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Analyzing the state of DataIntegrity Compliance in the Indianpharmaceutical industryA survey by Fraud Investigation & Dispute ServicesIntroductionThe pharmaceutical industry is currently one of the most dynamic industries in India.Its compliance structure is more complex, given that several regulatory watchdogssuch as the Indian Food and Drug Administration, the United States Food and DrugAdministration, the United Kingdom Medicines and Healthcare Products RegulatoryAgency, and other regulators guard it. Currently, the pharmaceutical industry isgrappling with various compliance challenges like never before — increased regulation,mergers and acquisitions, push toward harmonization and the endemic — dataintegrity concern.Our country has also been subject to increasing inspections by global regulatorybodies in recent times. There has been an upsurge in enforcement actions takenby regulatory bodies for cases related to data integrity. This issue has tainted thepharmaceutical industry in India and has forced companies to rethink their methods ofensuring quality and compliance, and sustaining http://business.In line with this, EY Fraud Investigation & Dispute Services team conducted a surveyto study the state of data integrity compliance in the pharmaceutical industry in From the great nation of India! the report details, our findings suggest that while most industry professionals areaware of Good Manufacturing Practices (GMP) guidelines, more than 30% had stillreceived inspectional observations from regulators in the last three years.We feel that there is a strong need for companies to realign their quality andmanufacturing compliance framework in line with regulatory guidelines. Companiesneed to undertake regular data integrity assessments to identify potential gaps.This also applies to the growing contract manufacturing units and small and mediumenterprises (SMEs), with both segments now keen to upgrade their computer systemsand facilities to meet regulatory guidelines.We would like to thank all the respondents and business leaders for their contributions,observations and insights without whom, this report would not have been assuccessful.We hope this report will be a useful read for you and help in contributing to meaningfulconversations within your organization, among senior executives, boards and otherstakeholders.Arpinder SinghPartner and National LeaderFraud Investigation & Dispute ServicesRajiv JoshiPartnerFraud Investigation & Dispute ServicesArpinder SinghRajiv Joshi1 | Data Integrity SurveyForewordIntegrity of data is the foundation upon which we make decisions of quality, safety andefficacy. When we use medicine at home or in a hospital it is very difficult to judge itsquality. Many symptoms of diseases and side-effects from medicine can appear to besimilar. Recording of data and information with integrity protects life. Without it wecannot differentiate between a counterfeit and authentic medicine.Under the US laws and regulation making false claims and not following CurrentGood Manufacturing Practices (CGMPs) can be criminal offence. When a company issupplying medicines to the USA it has agreed to abide by US laws and regulations.Deviating from these – can cause the product to be considered Adulterated. Testingthe product is not sufficient to remove this ‘Adulteration’ charge. Many do notunderstand why this is so. Take for example the failure incident which occurred in2007; it is commonly referred to as the Heparin Disaster. In this incident, establishedtesting methods did not detect the contaminant. More than 100 patients died andmany more injured. Unfortunately, history reminds us of many similar incidents. Howmany such incidents are not detected – is always a serious concern in the minds of theregulators.Following CGMPs, is a commitment, it saves lives. We make medicines – our firstpromise is – ‘Do No Harm’. With our skills, awareness, and commitment to a cultureof quality – we work to provide the ‘healing touch’ – Confidence and Authenticity. Ourmedicine must be better than placebos.I am extremely happy that EY Fraud Investigation & Dispute Services has conducteda survey on a topical subject like data integrity. This survey should help to improveawareness of data integrity issues as these issues need attention. Awareness is thefirst step, and companies should reflect on this and consider what may be relevant totheir situation. The most optimal approach to ensuring reliable compliance is to beproactive – a company’s quality system can and should correct and improve; and notwait for a regulatory inspection.I am confident that this message is being recognized by more and more leaders of thepharmaceutical industry. This survey is a reminder – a means to improve awarenessand to communicate this important message.For the past two years several pharmaceutical companies have requested my adviceon how to strengthen their culture of quality. In most cases, unfortunately, suchrequests come following a serious CGMP deviations which is noted by inspectors fromUS FDA or other authorities. Lapses in the assurance of data integrity is one of themost serious deviation. Recovering the lost trust is very difficult. The path to recoveryrequires commitment to transparency and thorough analysis of the potential impacton patient safety, thorough investigation to get to the root cause, effective correctiveactions and evidence that such observations will not repeat.On several such assignments I have worked with EY – their expertise in auditing anddata forensics provides the rigor and sufficiency needed to get to the root cause ofdata integrity issues. Their observations help client to evaluate CGMP relevance ofobservations they noted and to bring forward an effective plan for remediation. EYdata forensics team is world renowned, with their assistance a company can identify,categorize and prioritize necessary corrections.I congratulate EY on publishing such a relevant report and hope they continue tocreate awareness and share insights with more of these thought leaderships andinitiatives.Sincerely,Ajaz S. Hussain Ph.D., Founder Insight Advice & Solutions LLC. Frederick, MD, USA. Former Deputy Director,Office of Pharmaceutical Science, US FDA.Ajaz S. HussainData Integrity Survey | 2Each consumer expects that drugs they consume to be safe and effective. To ensure this,regulatory bodies such as the United States Food and Drug Administration (US FDA), theUnited Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA) and theIndian Food & Drug Administration (FDA) have set regulatory standards, typically referredto as Good Manufacturing Practices (GMP). GMP assures proper design, monitoring andcontrol of manufacturing processes and facilities for various systems. This is supported byunderlying data to trace manufacturing processes, which can prove evidence that the drugshave been manufactured as per agreed protocols.According to the Indian Ministry of Commerce, India has the second-largest number ofmanufacturing facilities outside of the US (523 as of March 2014) registered with the USFDA.1 Furthermore, India’s drug exports to the US have risen from US$1.25 billion in FY10to US$3.45 billion in FY14.2 With the growing importance of the Indian pharmaceuticalindustry in the global market, the number of foreign regulatory inspections has alsoincreased considerably. According to the US FDA Deputy Commissioner for Global RegulatoryOperations and Policy, Mr. Howard Sklamberg, the increase in the number of inspections inIndia is a reflection of the increasing size of the Indian pharmaceutical industry.31“Impact of 2013 US FDA Actions on Indian Pharma”,India Ratings and Research, May 2014, p. 32“USFDA plans to shift to an incentive based from apenalty based audits,” Economic Times, 18 March 2015,via Factiva, © 2015 Bennett, Coleman & Co. Ltd.3“Indian companies not singled out for inspections, saysUSFDA,” Economic Times, 18 March 2015, via Factiva,© 2015 Bennett, Coleman & Co. Ltd.4“CDSCO asks health ministry to release Rs. 1600 crunder 12th Plan for strengthening regulatory apparatus,“ 4 April 2015, Pharmabiz.com, via Factiva, © 2015Saffron Media Pvt. Ltd5”Intensive Scare,” Business Today, 16 March 2014,p.51.6“USFDA’s warning letters reason to worry for Indiandrug makers,” Business Today, 3 February 2015, viaFactiva, © 2015 Living Media India LimitedDid you know?The CDSCO has urged the Indianhealth ministry to release the US$2.9billion allocated to the department ofpharmaceuticals under the Twelfth FiveYear Plan, to strengthen its regulatorymechanism at the Central and State levelregulatory bodies.42000 2004 2008 2012YearNumber of inspections250200150100500JapanGermanyUnited KingdomFranceCanadaChinaIndiaIndiaHow India compares with other countries in FDA inspectionsThe most watched nations in FDA inspections5At the same time, the increase in foreign regulatory inspections has marred the image ofthe Indian pharmaceutical industry, with 8 out of the 19 US FDA warning letters issued tocompanies in India in 2014.6Data integrity – Currentlandscape in India3 | Data Integrity SurveyCase study FDA inspections on Indian pharmaceutical industries7Note: FDA’s fiscal year ends on 30 September. None = no inspection found or very minor inspections, voluntarymeans violations found but regulatory action not recommended and official means regulatory action has beenrecommended.There has been a subsequent rise in inspections by local regulatory bodies in India.In December 2014, Maharashtra FDA inspected more than 50 facilities to assesscompliance with GMP requirements. It has been reported that representatives of theState FDA have identified 250 companies certified by the Central Drugs StandardsControl Organisation (CDSCO) for conducting surprise checks.8The US FDA has invited Indian officials, both at Central and State Government levels,to accompany its team while inspecting pharmaceutical units within the country.This will help Indian regulators mature with respect to conducting inspections, liaisewith international regulators, and communicate GMP compliance expectations ofinternational regulators to the Indian pharmaceutical industry.11315128 2746 6118655448 5326020406080100120FY 10 FY 11 FY 12 FY 13 FY 14OfficialVoluntaryNone7“Drug firms remain in US FDA cross hairs, “ Mint, 30 March 2015, via Factiva, © 2015 HT Media8 “Pharmexcil to meet Maharashtra State FDA commissioner on Dec 11 Pharmexcil to meet Maharashtra StateFDA commissioner on Dec 11,” Express Pharma, 5 December 2015, via Factiva, © 2014 The Indian ExpressLimitedRepercussions of GMP non-complianceA leading company received a warningletter from a regulator for one of itsplants. Soon after, inspections wereconducted on other plants owned by thecompany. The result was the issuanceof another warning letter for CGMP noncomplianceto the http://company.An import alert was issued on select sitesafter the company failed to implementcorrective measures satisfactory tothe regulator. The approval of pendingAbbreviated New Drug Applications(ANDAs) was also jeopardized, therebyweakening its future business estimates.Other domestic and internationalregulators also followed suit, andeventually the company’s drugs wererecalled from multiple nations.Data Integrity Survey | 4Most regulatory bodies such as the US FDA, the UK MHRA, the India FDA and othersconduct inspections on pharmaceutical manufacturing sites or facilities to check if theycomply with the defined GMP standards. Inspection observations such as Form 483 areissued if the drug is manufactured under conditions that are non-complacent with GMPstandards. If a manufacturer fails to take satisfactory corrective action, the company maybe hit by a warning letter, import alert, or any other regulatory action. These regulatoryactions not only impact the revenue stream of the company, but also affect the drugmaker’s ability to get approval for new drug applications.Probable Implications of violating GMPsBusinesslossReputationaldamageRegulatoryinfluenceCompetitivedisadvantageDiversion toremediation andincrease inattrition rateIssuance of warning letters can lead to product recallsor import alerts, as well as a fall in the stock prices oflisted companiesList of companies violating guidelines are posted on aregulator’s website, making the information publiclyavailable, which can be further picked up by the media,thereby tarnishing the company’s reputationAdditional inspections can be carried by otherregulatory bodies or customers tarnishing thecompany’s reputationCompetitors can leverage this opportunity to enhancetheir market shareDiversion of management and employees’ attention fromtheir daily activities, to focus on Corrective Action andPreventive Actions. The lengthy remediation processtends to cost time, money and often loss of talentDid you know?Import alerts issued against Indian plantsin 2013 accounted for 49% of the total43 imports alerts issued by the US FDAworldwide.99 “Impact of 2013 US FDA Actions on Indian Pharma, “India Ratings and Research, May 2014, p. 3Violations of GMP5 | Data Integrity SurveyWarning letter extract10“There was incomplete raw data to support the test method validation/verification activities for the test methods used for your APIs.”“Our investigators identified calibration and media preparation recordsthat were not authentic in that the persons that signed each record ashaving performed the activity were not at work on the day the work wasaccomplished.”“Our investigators found that laboratory analysts did not document thebalance weights at the time of sample weighing. Specifically, sampleweights used in calculations were created after the chromatographic runs.The analyst admitted that the sample weights that were represented as rawdata from the analysis actually were backdated balance weight printoutsproduced after the analysis and generated for the notebooks. These sampleweights were used to calculate related compounds and impurities used insupport of method validations submitted in FDA drug applications.”The survey states that although 87% respondents signed off their understanding andcompliance with GMP norms, it was noted that 30% still responded to have receivedinspection observations from a regulatory body over the last three years. This could raisequestions on the effective implementation of GMP norms. It is also critical to understandif prevalent GMPs in the companies are effective enough to have invited inspectionalobservations by these regulatory bodies.Q: Do your employees have a sign offto confirm their understanding andcompliance with cGXP such as currentgood manufacturing practices (CGMPs)and current good laboratory practices(cGLPs)? 87% 30%Q: In the last three years, has yourorganization received any letter froma regulatory body entailing theirobservations from their inspection of yourfacility (e.g. Form 483, Warning letter)?10 US FDA, Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and ActivitiesWarning Letters, 2014Data Integrity Survey | 6Manufacturing drugs for patient well-being is the most important responsibility of a pharmacompany; and so is maintaining data to ensure traceability of a batch to its origin.Dataintegrity asserts that data records are accurate, complete, attributable, legible, and intactand maintained within their original context, including their relationship to secondary datarecords. This definition applies to the data recorded in electronic and paper formats or ahybrid of both.Considering that raw data acts as an evidence that drugs are safe, efficacious andmanufactured as per appropriate quality standards required, violation of data integrity isconsidered to be grave by leading regulators such as the US FDA, the UK MHRA, HealthCanada, Therapeutic Drugs Administration (TGA) and the Indian FDA, all of which mandatedata integrity.Recently, the drug controller in Karnataka, a state in Southern India has insisted onpharmaceutical companies in India adhering to data integrity and security mandated inSchedule L1 of the Drug & Cosmetic Rule 1945.11 In March 2015, the UK MHRA releaseda fresh guidance document stating their expectations from companies on data integrity.12In fact, the US FDA, in its warning letter to companies, typically recommends that thecompany undertake comprehensive and global assessment measures and hire a thirdparty auditor experienced in detecting data integrity problems. Hiring a third party auditorprovides greater assurance to the agency of the independence and reliability of findings.These expectations of regulators highlight the growing criticality of data integrity.Did you know?Karnataka Drug Controller mandatedcompanies to adhere to data integrity asprescribed in Schedule L1 of the Drugs &Cosmetic Rule 1945.11 “Karnataka DC insists on adherence to Para 15 C of Sch L1 in D&C Rule for data integrity compliance, “20 January 2015, Pharmabiz.com, via Factiva, © 2015 Saffron Media Pvt. Ltd12 “MHRA issues GMP data integrity definitions & guidance document for pharma cos, “ 31 January 2015,Pharmabiz.com, via Factiva, © 2015 Saffron Media Pvt. Ltd13 “US FDA expects Indian pharma to seek third party audits to resolve data integrity issues”, 23 March 2015,Pharmabiz.com, via Factiva, © 2015 Saffron Media Pvt. LtdQ: To address the data integrity observations, has your organization done an audit or areview to assess potential gaps in assurance of data integrity?67% respondents have conducted an auditor a review to assess potential gaps in theassurance of data integrity, while 33% havenot conducted a data integrity review. 67%“US FDA has been noticing thatespecially with Indian companies, it didnot rely on their capability to resolvethe data integrity problems withoutexternal support. Now it expects Indianpharma to seek the expertise of thirdparty auditors and consultants toresolve data integrity issues and ensuretotal compliance.”13Getting a stamp of reliabilitythrough data integrity7 | Data Integrity Survey“The new challenge before the industry is the current regulatoryexpectation of assuring the accuracy and consistency of the datagenerated over the product life cycle that is pivotal to productquality. It is noteworthy to highlight that the Indian industry hasresponded to this challenge with a learning mindset. There hasbeen a paradigm shift in industry’s approach moving from areactive to proactive compliance with visible and demonstrablesenior management engagement. This initiative will helpcompanies in creating a culture of quality such that compliancewith the required quality attributes of data is engrained in theorganisational culture and will become the way of life.”S.M. Mudda Chairman, Regulatory Affairs Committee, IDMAMember, Committee of Administration, PharmexcilEY insights: Proactivitysees a winning streakRegulatory actions such as import alerts or warning letters createan immediate need for companies to conduct data integrityreviews. In our experience, the Indian pharmaceutical industry isnow taking major strides and becoming proactive. Over one thirdof the total data integrity reviews conducted by EY were doneproactively by GMP compliance conscious companies across large,mid and small enterprises. Industry stalwarts opine that proactivedata integrity review and GMP compliance is now the need of thehour to circumvent regulatory actions around data integrity noncompliance.Data Integrity Survey | 814 US FDA, Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and ActivitiesWarning Letters, 2014Q: Does your organization have a clearlydocumented Standards OperationProcedures (SOP) on backup and Deletionof Laboratory data such as files generatedby HPLC/GC/UV/IR?Q: Is Quality Assurance (QA) adequatelystaffed to witness and review themanufacturing and testing of all theproducts independently? 13% 18%13% do not have clearly documentedStandards Operation Procedures (SOP) onbackup and Deletion of Laboratory datasuch as files generated by HPLC/GC/UV/IR.18% do not have adequately staffed towitness and review the manufacturing andtesting of all the products independently.Did you know?The UK MHRA recently releasedguidance in March 2015 emphasising ondata integrity.57%Q: Is there work pressure on themanufacturing personnel to meet KeyPerformance Indicators (KPI) such asvolume of output, low rejection ratio,overall equipment effectiveness?Our survey indicated that over 57% ofthe employees agreed to have seen workpressure on the manufacturing personnelto meet Key Performance Indicators suchas volume of output, low rejection ratio,overall equipment effectiveness.Warning letter extract14“Your firm lacked accurate raw laboratory data records for API batchesshipped by your firm. The inspection revealed that batch samples wereretested until acceptable results were obtained. In addition, your qualitycontrol (QC) laboratory failed to include complete data on QC testingsheets. Failing or otherwise atypical results were not included in theofficial laboratory control records, not reported, and not investigated.”9 | Data Integrity SurveyShortage of manpower: Shortage of staff and excessive workpressure can lead to inaccurate and incomplete documentation.Quantity over quality: Employees may be forced to compromisethe acceptable quality levels in order to meet production targets ordispatch timelines.Lack of awareness: Often, employees are not trained or inadequatelytrained to understand GMPs. This causes employees to consideractivities as a chore rather than understanding their relevance in lightof GMP.Effectiveness of trainings: While the company may hire the bestinternational trainers, employees mentioned that there werelanguage and accent barriers, which prevented the employees fromunderstanding the content, thereby making the training redundant.Key root causes of dataintegrity issues as per EY’sexperience:Data Integrity Survey | 10A company’s standard operating procedures (SOPs) describes how processes are to beperformed while manufacturing a particular drug or formulation. During implementation ofthese processes, the US FDA registered company needs to comply with Title 21 of the Codeof Federal Regulations (CFR) – Part 11, commonly known as “21 CFR 11”. 21 CFR Part11 establishes the criteria under which electronic records and signatures are stored and isconsidered trustworthy, reliable and equivalent to paper records by the US FDA.According to the US FDA 21 CFR 11.10e,“Use of secure, computer-generated, timestampedaudit trails to independently record the date and time of operator entries andactions that create, modify or delete electronic records. Record changes shall not obscurepreviously recorded information. Such audit trail documentation shall be retained for aperiod of at least as long as that required for the subject electronic records and shall beavailable for agency review and copying.” This indicates US FDA’s expectation that audittrails are enabled.Q: Are you aware of 21 Code of FederalRegulations (CFR) Part 11 compliancerequirements?25% of the respondents indicated thatthey were not aware of 21 CFR Part 11compliance requirements. 25%Q: Are audit trails on laboratoryequipment always enabled in yourorganization?21% stated that audit trails on labequipment are not always enabled in theirorganizations.21%Case studyAdvantage - Proactive reviewA pharmaceutical major approached EY to conduct a proactive data integrityassessment at multiple sites. The scope was focused on the review of data associatedwith laboratory testing, such as test data of High Performance Liquid Chromatography(HPLC), Gas Chromatography.Basis on the extensive forensic data analysis exercise, EY managed to pull out datafiles that were deleted, re-processed, re-run, and potential trial runs. The company isnow investigating and assessing the root cause of the improper data files, and puttingCorrective Action and Preventive Action (CAPA) in place.Did you know?• The UK MHRA stated in theguidance note dated March 2015,that companies should focus onthe lab when examining the dataintegrity of contract manufacturersas most of them reintegrate the datato save time and money.• The guidance note also directs thatfull retention of audit trails shouldbe implemented to show all thechanges made to the data fromprevious to original. The details ofthe person making the changesshould be recorded with the timeand reason.Requirements under21 CFR Part 1111 | Data Integrity SurveyQ: Are the employee login ids and passwords for laboratory systems such as HPLC, GC’sshared in your organizations?33% mentioned to have shared employeelogin ids and passwords for laboratorysystems such as HPLC, GCs. These numbersindicate that organizations still need tomake a significant headway in terms ofbeing compliant with 21 CFR 11 http://standards.It is important that the management paysmore attention to these requirements, asfailure to do so can invite regulatory and/orpenal actions on the company.Q: Who has administration rights for laboratory systems such as HPLC, GC’s. in yourorganization?Nearly 72% users in the quality control department have IT administration rights forlaboratory systems such as HPLC, GC.56%28%16%Quality control analystInformation technologyadministratorAll quality control users 33%15 US FDA, Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and ActivitiesWarning Letters, February 201416 US FDA, Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and ActivitiesWarning Letters, 2014Warning letter extract16“Your firm did not have propercontrols in place to prevent theunauthorized manipulation of yourelectronic raw data.”“There was no written explanationfor deletion events observed onaudit trails for your standaloneHPLC units.”“Our investigators identifiedthe practice of performing trialinjections for HPLC analyses priorto running the release and stabilitytests that are then reported.”“Good manufacturing practice (GMP)deviations detected during inspectionsrelated to electronic data submissionswas elementary and urgentlyrecommended companies to get a thirdparty auditor or pharma consultant.These experts could first perform anin-depth GMP review and ensure dataintegrity deficits are removed.”15Data Integrity Survey | 12Over the last few years, corporate India has seen the rise of a new kind of crusader – thewhistle-blower. These champions have tried to uncover many corporate scams relatedto financial fraud, bribery and corruption. In the pharmaceutical sector, there havebeen instances when issues around drug adulteration and misrepresentation have beenunearthed due to whistle blowing. With the growing maturity of global regulations,protection offered to whistle-blowers and the possibility of being awarded bounties, therevolution of whistle-blowing has gained significant momentum.Reviewing the legalitiesIndiaThe Companies Act 2013 has made it mandatory for listed companies or such class ofcompanies to establish vigil mechanisms for their directors and employees, in order to reportgenuine concerns in the recommended manner. Clause 49 of the SEBI listing agreement alsolays down similar provisions.Since drugs relate to patient safety, a sensitive subject, the CDSCO has devised a rewardscheme for blowing the whistle on spurious or fake drugs.USAUnder the Dodd-Frank Wall Street and the False Claims Act, an individual with knowledgeof fraud committed by a business may blow the whistle to defined regulatory bodies. If theclaim is proven valid, the whistle-blower is entitled to a percentage, or “bounty”, of the sumrecovered. Additionally, the Department of Justice (DoJ) has enforced CGMP violationsunder the False Claims Act.Case studyA bounty-ful rewardAn employee of a leading companyblew the whistle on the company’squestionable manufacturing practices.This was corroborated by providingevidence to the regulatory authoritieson the company falsifying drug data andviolating good manufacturing practices.The investigation resulted in the drugmaker pleading guilty to the wrongdoingand paying a hefty sum in settlement.The whistle-blower was awarded asignificant sum from the regulator.Whistle-blowing, the nextbig wave13 | Data Integrity SurveyDid you know?• The CDSCO has implemented areward scheme for individuals whoreport companies manufacturingfake or spurious drugs.• Association of Certified FraudExaminers reports that whistleblowingis the most powerfulmethod of identifying fraud inorganizations.Q: Does your organization have a whistle-blowing mechanism to report and investigatequality concerns, if any?Whistle-blowing, a salvage opportunityOur survey revealed that while 47% of the respondents had whistleblowing policies andmechanisms implemented internally, 28% indicated that their organizations did not havesuch frameworks in place. This means that while a lot of the stakeholders may genuinelywant to help companies by flagging any unethical acts or wrongdoing, the lack of whistleblowing mechanisms offered by the companies could force them to report the potentialfraud http://externally.In fact, there has been an uptick in whistle blowing complaints in India over the last twoyears. According to the last released data from the Central Vigilance Commission (CVC),India received close to 450 complaints in just the first half of 2014, while the annualnumber stood at 698 complaints in 2013.1725%37%10%28%My organisation has awhistle-blowing policyand a mechanismoutsourced to a thirdparty service providerMy organisation doesnot have a formalwhistle-blowing policyMy organisation has awhistle-blowing policyand a mechanismMy organisation has awhistle-blowing policy17“More disclosures of corruption in the govt?,” Hindustan Times, 10 August 2014, via Factiva, © 2015 HT MediaLimitedData Integrity Survey | 14Proactive approach to quality and complianceWith Government of India’s focus on the “Make in India” initiative, and commitment tobattling fraud and corruption, the pharmaceutical industry is being very closely watched torecoup and lead the initiative. The government is more vigilant and is emphasising on GMPcompliance guidelines set by global, central and state regulators. While the pharmaceuticalindustry is committed to gearing up on quality and compliance, the remedy for the industrynow is to get more proactive in its quality compliance drives. The same can be done byadopting regular internal and external data integrity assessments to identify gapsif any, such as to identify if laboratory test data files have been deleted outside ofroutine archiving process, monitor data to identify potential trial runs, re-processedfiles and use of common or shared login id and password. The company is to then divulgeinto the root cause of these issues and address the gaps without camouflaging or hidingfacts, as data integrity essentially is, “do as you say, and say as you do.”In fact, even companies with a good track record with regulators and regardless of theexisting or anticipated GMP compliance concerns should initiate periodical proactive dataintegrity assessments to assess their current state of quality compliance. This not only actsas self-assurance, but may also provide comfort to regulators, customers, investors on themanagement’s commitment to quality and compliance.Harmonization, the bridge to inclusive growthCountries are now evolving their individual regulatory frameworks so that they are closelyaligned to global standards. Harmonization of regulatory standards will help companiesimprove efficiency by following a single guidance note or dossier. As such, regulators from thewestern world are typically seen to lead the way, and hence, compliance with requirementssuch as 21 CFR Part 11, data integrity, will soon be minimal compliance requirements for theIndian pharmaceutical industry to abide http://by.It is then imperative that the Indian pharmaceutical industry do more sooner than later oncompliance with essentials of 21 CFR 11, such as enable audit trail of laboratory systems,respect unique user id and password at all times, ensure administration rights arewith the right people and department, that computer systems are validated and so on.Having an integrated periodical proactive data integrity assessment program, accompaniedby upgraded computer systems in line with 21 CFR 11, will not only aid the progress of Indianpharmaceutical companies but also improve the industry’s tarnished image.“Running away from any problemonly increases the distance from thesolution. The easiest way to escapefrom the problem is to solve it.I believe and practice the abovestatement. With the hugeopportunity and growth potentialthat the pharmaceutical contractmanufacturing space has in India,I think the time has come for theindustry to become more proactiveby doing detailed data integrity selfassessments.Proactiveness comes with faith,courage and commitment to the cause,giving the entire initiative a positiveenergy, whereas reactiveness is drivenby fear. Support this proactivenesswith apt training to employees,technology upgradation, continuousmonitoring reviews, and this willlay the foundation for creating andsustaining the highest level of qualityand regulatory compliance by anycompany. “Mehul Shah,Head – Contract Manufacturing,Indian Drug Manufacturer’sAssociation (IDMA)Looking ahead15 | Data Integrity SurveyThis report is based on the responses received from over 170respondents from the Pharmaceutical Industry in India during theperiod January–March 2015. The principal respondents were fromBusiness Management, Corporate quality, and Legal and Compliancedomains. They represented a mix of active pharmaceutical ingredients,formulations excipients and others supplying domestically as well asexporting to countries such as the USA, Europe, Japan, Australia, ZETC Bollywood addition to the survey results, the report also includes the casestudies and insights which are based on EY’s experience over a periodof time, views of industry personnel and the recent incidents reportedin news.Survey methodologyNote: Not all questions were answered by all respondents; hence the total percentage is derived bases the total number of responses received for each question.Data Integrity Survey | 16Dealing with complex issues of fraud, regulatory compliance and business disputes candetract from your efforts to achieve your company’s potential. Enhanced management offraud risk and compliance is a critical business priority — whatever the industry sector. Withour more than 2,000 fraud investigation and dispute professionals around the world, we willassemble the right multi-disciplinary and culturally aligned team to work with you and yourlegal advisors. In addition, we will provide you the benefit of our broad sector experience, ourdeep subject matter knowledge and the latest insights from our global activities.FIDS India• Deep competencies: Our FIDS team has specific domain knowledge along with wideindustry experience.• Forensic technology: We use sophisticated tools and established forensic techniquesto provide requisite services to address individual client challenges.• Global exposure: Our team members have been trained on international engagementsand have had global exposure to fraud scenarios.• Market intelligence: We have dedicated field professionals, who are specificallyexperienced and trained in corporate intelligence, and are capable of conductingextensive market intelligence and background studies on various subjects, industries,companies and people.• Thought leadership: We serve a variety of leading clients, which gives us deep insightinto a wide range of issues affecting our clients and business globally.• Qualified professionals: We have a qualified and experienced mix of CharteredAccountants, Certified Fraud Examiners, Lawyers, CIAs, CISAs, engineers, MBAs andForensic Computer ProfessionalsSOURCE-https://webforms.ey.com/Publication/vwLUAssets/ey-data-integrity-compliance-in-the-pharma-industry/$FILE/ey-data-integrity-compliance-in-the-pharma-industry.pdfTHANKS FOR UPVOTE

There are many ways in which a thing can be true, and not all of them are equal.While ProPublica’s story is mostly true in a narrow sense, it’s also concerningly simplistic. It gives us a taste of the truth — enough to make us drunk with outrage. But what it doesn’t do is arm the reader to participate in the sort of discussion that might solve the real problems underneath.Compounding this, the dozens of clickshare re-writes of ProPublica’s story by other outlets have almost all been worse. What the ProPublica version lacked in breadth, the rest lack in depth (and also breadth).While we’re going to going to tackle those themes a bit more while unpacking the main elements of the tax story itself, just two bits of house-cleaning first:My main interest here is bias. Not political bias, mind you. More in the vein of what Jon Stewart suggested was the default bias of all mainstream media: “sensationalism, conflict, and laziness”.Some angles of this story get into murky territory, especially as it concerns legal recourse. I’ve done my best to be transparent about where I’m sure and where I’m speculating. As ever, I offer financial rewards for all corrections and meaningful improvements.Ok, on we go.Historical ContextBack in 1998, Congress passed the IRS Restructuring and Reform Act, which, among other things, spelled out one notable big-letter goal: “having 80% of Federal tax and information returns filed electronically by the year 2007”.Fast forward to 2002. The Bush II administration announced a new policy related to achieving that 80% goal: the creation of Free File Inc. (hereafter FFI) as part of the Free File Program (FFP).The basics:FFI is a consortium of a dozen major tax-prep companies.FFP is a deal that FFI made with the IRS wherein they would create software that allowed the bottom 60% (now 70%) of US earners to file their taxes electronically for free (no cost to the IRS or the filer).In exchange, the FFI demanded a non-compete agreement from the IRS. For as long as FFI was supplying these freebie filing options, the IRS couldn’t go and create their own.The FFP wasn’t law. Just a department policy predicated on a renewable contract between the IRS and the FFI. (This contract is referred to as a “memo of understanding”, or MOU.)Now, there are many ways of parsing this. On the one hand, free electronic filing for 60% of taxpayers was a win. Plus the government didn’t have to bother with creating this software from scratch. On the other hand, FFI members had motivations beyond charity and civic pride. In exchange for their “donation”, they got to ensure the IRS wouldn’t cut their revenue streams by creating a better option of their own. (They knew that most filers would end up buying a paid product regardless of free options, which is something we’ll get to.)All said though, this being a negotiated contract meant it was mostly a win-win. The IRS got to focus elsewhere, and taxpayers got something useful. And in the event that the deal no longer made sense, the IRS was free to either renegotiate or try something new.What Happened This WeekThe House passed the Taxpayer First Act of 2019 this past Tuesday. Section 1102 of said bill began with this clause:The Secretary of the Treasury, or the Secretary’s delegate, shall continue to operate the IRS Free File Program as established by the Internal Revenue Service and published in the Federal Register on November 4, 2002 (67 Fed. Reg. 67247), including any subsequent agreements and governing rules established pursuant thereto.The force of this is pretty simple: the FFP (and the MOU underlying it) would graduate from department policy to federal law.But before we get into the implications of that, I want to contrast the above with a clause from a previous (unpassed) bill:The Secretary of the Treasury, or his delegate, may not establish, develop, sponsor, acquire, or make available individual income tax preparation software or electronic filing services that are offered under the IRS Free File program, except through the IRS Free File program, the Internal Revenue Service’s Taxpayer Assistance Centers, Tax Counseling for the Elderly, and volunteer income tax assistance (VITA) programs.Note the difference: in this second version, the non-compete aspect would have been part of the federal legislation itself (as opposed to it being a clause in an MOU referenced by the law). It also would have limited the IRS from sponsoring private partners outside the confines of the FFP. This is the kind of bill that lobbyists really wanted. What they got this week was a distinctly lesser win.Anyway, as for the MOU in question (now in its 8th version, having been renewed late last year), there are a few clauses in play here:In recognition of this commitment [of FFI members to offer free filing software to the bottom 70% of earners], the federal government has pledged to not enter the tax preparation software and e-filing services marketplace.But while this exchange is a classic quid pro quo, this isn’t to say the deal is entirely equal.Any unilateral changes imposed by the U.S. government on FFI whether by statute, regulation, or administrative action will result in an immediate re-evaluation of the decision to continue FFI, and could result in an immediate suspension of free services upon the decision of each Member.This is where things get really interesting, and where FFI lobbyists clearly earned their money. The new bill, while less onerous than previous attempts at codifying the MOU, does include one slippery sentence: it mandates that the government “shall continue to operate” the FFP.Here’s why this matters: if the IRS decides to revise the MOU to remove the non-compete angle, the FFI would have a powerful incentive to exercise the above clause. The presumption is that they’d then argue something to the effect of “the government’s unilateral decision forced our hand, and now the FFP is basically dead, and the law says that the government needs to keep the FFP alive”. (I’m not sure how successful this argument might be, but it certainly seems that the legislation was crafted to allow the FFI to make it.)But there’s one more thing from that MOU that represents a curveball:Should the IRS commit funding to offer Services for free to taxpayers, the IRS shall notify FFI immediately.This clause has been in the MOU since the first draft. It basically allows the FFI to stop offering the free services if the IRS begins their own. But this is somewhat in tension with the unilateral changes bit. If the IRS exercises an option that’s always been part of the MOU, does that weaken a potential claim by the FFI?(To be clear, I don’t know how this would play out in court. Different judges could rule differently — though there are surely precedents I’m unaware of that might make certain outcomes more or less likely. What is clear though is that there would be non-trivial litigation risk for the IRS if they were to drop the non-compete and the FFI were to object.)Anyway, there’s more to the MOU that we need to look at, but I want to set up that discussion by reviewing a few other things first.There Must Be A Better Way!The crux of this week’s commentary has mostly been “man, it would be great if the US could be like other countries and have an option where the IRS just sends out a pre-filled postcard, and all we need to do is verify and sign it”.The easy narrative here is that this system doesn’t exist solely because of the FFP (i.e., the companies that make up the FFI don’t want to lose revenues, and have thus thrown lots of lobbying dollars at Congress to keep the FFP in place, and that’s why we can’t have nice things).While there are other problems with this narrative, I think it’s worth getting into a fuller list of cautions that past studies have raised as it concerns the US pursuing such a program (pulling mostly from this 1996 GAO report, though leaving out all the arguments that have been obviated by tech advances):At the time, 55% of filers would have needed to make amendments to any pre-filled form the IRS could have come up with (or else would have needed to just do their own filing from scratch). While that number would be lower now, the complexities of US tax regimes (at both federal and state levels) combined with the backwater efficiency of most inter-governmental data-sharing systems would keep this number from being quite as low as that of most other developed countries.Tax prep companies pay lots of tax on their profits, and they employ lots of people who pay lots of tax on their wages. If you eliminate those jobs, the government takes in less money. Plus governments have to pay benefits to unemployed people until they find new work.Lots of US citizens don’t trust the IRS, which could mean that lots of pre-filled forms would be challenged, thus increasing the overall workload. In contrast, the selling point of “we’re going to help you pay the fewest dollars to the big bad government” is compelling to lots of Americans, and often solicits more trust (even if it shouldn’t).There was a fear at the time that people would be less likely to declare side income if their filing was pre-filled (I’m sure there’s relevant data from other countries who use this system — would love a link if any reader happens to know of quality research here).Employers are really bad a sending on forms in a timely way, making it hard for the IRS to gain the needed data to make correct calculations while also maintaining their current tax calendar.We can add two more things to this list:The IRS is intentionally under-funded (down nearly 20% this decade, despite a host of new responsibilities). It’s hard to imagine either party giving them loads of money to institute new programs in the current climate, whatever their potential benefit. It’s just an electoral nightmare. Lobbyists and messaging consultants have done too effective a job at poisoning that particular well.US government agencies are generally bad at managing software projects. It isn’t at all clear that they’d get further developing their own system vs. forcing the FFI members to improve their existing offerings.Now, those arguments vary in power. I’m skeptical that even taken together they mean that the IRS shouldn’t try a large-scale pilot. But the last two are definitely non-trivial. Giving the IRS a larger budget is widely considered a non-starter, and changing political perception there would be a massive undertaking. But if you had to get them more money for either oversight or building their own program, oversight would be a whole lot cheaper, and may have a higher ROI.Bad Faith EffortsYou might be wondering: if the FFP has been around since 2002, why do only ~3 million people a year use it? (A number that’s been trending downward.)There are a handful of high-level answers here:Per the MOU (4.35), it’s actually the IRS’s responsibility to market the FFP. Doing this well would require them having a budget to do so (and them having the institutional competency to use that money well).Also per the MOU (4.15.4), FFI members are responsible to advertise the free service from their “Free File Landing Page”. They are not responsible to make this landing page easily accessible. In most cases, said pages are only reachable via the IRS’ little-known FFP program page.Most of the FFI’s FFP offerings suck (on purpose). The IRS has the right of review, but doesn’t use it very effectively. (As the FFI largely sees improving these offerings to be contrary to their financial interests, they’re only going to go as far as they’re pushed.)Some FFP offerings suck less, but the FFI is dominated by Intuit (TurboTax) and H&R Block (i.e., the two players most opposed to improvements).Free options aren’t generally good at helping you find all eligible deductions, leading most filers to opt for a paid service they perceive to be better at that.Filing taxes normally via TurboTax or a local outfit isn’t all that hard or expensive, and most taxpayers just aren’t bothered enough to seek an alternate solution.Of those factors, I want to focus on 3 and 4. To illustrate what bad faith means here, let’s look at how TurboTax goes about fulfilling their FFP obligations.Now, you might be thinking “well, that’s no so bad at all! — after all, the free option is clearly marked in an attractive way”.But then you click on that “simple tax returns” subheader and you’re greeted with a curious disclaimer:Hmm. Now why would these things not be covered? The obvious answer would be that artificial restrictions are useful for pushing customers to premium options. Pretty normal practice. But doesn’t the MOU forbid this type of upselling on FFP offerings?Trick question! The above offering has nothing to do with the FFP.TurboTax does have an FFP option, which does cover all those situations from the disclaimer. It’s just hidden. The only way you’d ever find it is if you came in via a link from the IRS’ FFP program page. The fact that the two offerings share a confusingly similar name (“Free Edition” vs. “Free File”) is, ahem, a bit of poor luck. They say it isn’t their fault if consumers are confused, as it isn’t their job to educate them.And this is hardly the only kind of spirit-violating nonsense that FFI folks have gotten up to. Remember how the MOU demanded that the lowest 70% of earners all be given free options? Well, the MOU didn’t demand that each provider meet that goal individually — just collectively. The natural consequence? Each FFI provider has seemingly arbitrary restrictions on location and age/income ranges. While you’re guaranteed (if under the income cap) that one of them will work for you, the same one might not work for your sibling or next-door neighbor. It may not even work for you two years in a row! It’s complicated enough that the IRS had to develop a lookup tool that requires you to complete a survey to match you with the right offering. Friction, friction, friction.Why Governments Suck, Part IIf you read through the MOU, you might find yourself surprised at some of the clauses.4.36.3 - IRS and FFI mutually agree to support and promote Free File as an “Innovation Lab” to test, pilot, and offer capabilities to simplify taxpayer compliance, such as data importation offered by industry as described herein, and such as IRS’s Application Programming Interface (API) projects […]Yep, you read that right: the FFI actually has a mandate to create the sort of tax-filing experience we all dream of. (There’s a whole section on this.) On the balance, the MOU is honestly pretty taxpayer-friendly. The problem isn’t here — it’s in the fact that the US government is terrible at private-sector oversight, rendering most of these deals somewhere between one-sided and meaningless.This is why all those battles that Roger and Paul and Grover and Newt and Ralph fought in the 80s/90s mattered. They weren’t conservatives fighting against the encroachment of progressive values or the nanny-state. They were power-brokers looking to get paid by corporations keen to reduce oversight to something of a farce. (And they definitely had their allies on the left in this effort.) Now, sure, reasonable people can disagree on how much oversight the market needs. That’s why we have a democratic system that necessitates healthy compromises. Good legislation should certainly aim for balance, and so on. But what those men did was use the “government vs. markets” debate, not to shift the compromise, but to obscure what they were really doing: making sure that whatever compromises Congress reached would be toothless anyhow.The reality here is that the MOU itself is largely fine, as is the new law. The litigation risk of backing out of the non-compete, however severe, is mostly a red herring. The IRS is still free to help other competitors (like CreditKarma) enhance their free services, and there’s no reason that FFI offerings couldn’t be made to be as good or better than whatever the IRS could come up with themselves. That the current options suck isn’t about who is building the software. It’s about the IRS having no real resources to either enforce/sweeten the MOU or market the FFP.And that, in turn, is a problem with public perception. The US can easily afford to properly fund the IRS (it would actually be a net savings on a longer timeline). But elected representatives are terrified of trying, largely thanks to the efforts of the Grovers of this world — along with a little help from the media.Why Governments Suck, Part IIIt isn’t a new observation that good governance requires an informed public. This has been a maxim since the first Greek experiments with democracy. Literacy and engagement are the central pillars of any nation worth living in.So why is the press doing such a poor job informing the public in a way likely to arm them with the data and context required to engage well?Let’s start with the ProPublica piece that set off this whole dialogue:Congress Is About to Ban the Government From Offering Free Online Tax Filing. Thank TurboTaxSetting aside the misleading implications of the headline as worded, let’s look at the article’s first paragraph:Just in time for Tax Day, the for-profit tax preparation industry is about to realize one of its long-sought goals. Congressional Democrats and Republicans are moving to permanently bar the IRS from creating a free electronic tax filing system.Note those words: “permanently bar”.Remember that Stewart line from the beginning about “sensationalism, conflict, and laziness”? Keep that in mind as you parse what exactly “permanently bar” might mean. It isn’t a term of art. Congress has no power to ban anything forever. That’s not how the law works. The closest we could get is a constitutional amendment, but even those can be re-written and re-interpreted. Laws, by their nature, are transitory things.The real focus of this new legislation isn’t permanence, but difficulty. The FFI hardly expects the status quo to last another 17 years, much less indefinitely. They just expect that litigation risk (and two-branch support) will act as a speed bump on change. Their monopoly is still written in pencil, but the erasers are now just that little bit extra harder to come by, which makes their clients happy.Now, you might object that I’m being over-sensitive to the meaning of words here, and that ProPublica’s take wasn’t all that bad. And this is where we have to get a little philosophical. Some believe that every journalist’s responsibility is something to the effect of “collect some facts, avoid outright mistakes, and work with an editor to make your story marketable”. To me, this is the equivalent of requiring them to “tell the truth and nothing but the truth” while leaving out the bit about “the whole truth” as either unimportant or impractical. The story that ProPublica told was true, but it agitated more than it informed. The FFI likely read it and said “well, this will make this week suck, but the outrage isn’t well-directed to any end that represents a real obstacle to us, so, hey, whatever”.Look, good journalism is hard. I get that. And there’s certainly value to communicating key facts quickly. Not every news bulletin can wait on an exhaustive search for whatever we might consider a realist approximation of “the whole truth”. But it seems undeniable to me that the current model is broken. And this is nowhere more evident than in how primary reporting is reprocessed by secondary publishers in their quest for clickshare.Say you thought “permanently bar” was wrong but not very wrong. How do you feel about the first sentence of TechCrunch’s repackage?Thanks to pressure from tax preparation industry, Congress is getting ready to ban the IRS from ever building a free electronic tax filing system.Does TechCrunch say “ever” here if ProPublica didn’t use “permanently” first? If I was a casual reader, I’d assume that “ever” implied some real finality, like a door being shut that couldn’t be re-opened. (Where the reality here is that this particular door can be sprung with precisely the same force with which it was closed.)In the same vein, consider this follow-on by Popular Mechanics:Filing Your Taxes Could Be Way Easier, But Congress and Tax Companies Are Conniving To Make Sure It Stays TerribleConniving! Reminds me of that old saw about how one shouldn’t ascribe to malice what’s better explained by incompetence (or, in this case, inadequate resources).Anyway, as to the article itself:Tucked away in section 1102 of the bill, which relates to the IRS Free File Program that ensures fee-free filing for people under a certain income threshold, is language that subtly prevents the IRS for developing its own system by mandating that the agency continue to work with the private sector in this endeavor. In other words, the legislation locks us all into the status quo.I credit ProPublica with at least this: however narrow their perspective was, at least they did their homework. Their bias was more toward sensationalism and conflict than laziness. Popular Mechanics (and dozens of others) went for the full trifecta, in a much more brazen way.As a non-exhaustive list of problems here:While, yes, filing your taxes could be “way easier”, shifting the software burden to the IRS would be no guarantee of making this so.Section 1102 was the 3rd of 47 sections. If their goal was to hide it in the stack, the crafters did a poor job.There’s a deep confusion here between the bill and the MOU.The actual non-compete language is the opposite of subtle.This is like the game of Telephone. Most secondary publishers do near-zero research and just repackage the primary article, leaving the signal to degrade with each step.And then we have Twitter.Who says there is no common ground in politics?Democrats and Republicans in the House just unanimously passed a bill that makes it illegal for the IRS to create a system to let Americans file their taxes for free online— Judd Legum (@JuddLegum) April 10, 2019This system already exists! It’s called the FFP. That the IRS can’t create their own competing system to the one they already manage is a much narrower issue.(Also, for the record, passing a bill by acclimation isn’t the same as passing one via a unanimous vote.)It's hard to find a clearer example of Congress sabotaging the public good than a bill -- lobbied for by TurboTax -- prohibiting the Internal Revenue Service from developing a free online system for filing your taxes.https://t.co/4HuIZc9ZKO— Justin Wolfers (@JustinWolfers) April 10, 2019Ditto to above. This system already exists, and was developed under the auspice of the IRS.Also, the linked NYT piece (from their editorial board) includes this gem: “Instead of barring the I.R.S. from making April a little less miserable, why isn’t Congress requiring the I.R.S. to create a free tax filing website?”Umm, because the IRS already mandated the creation of several such websites? The assumption that the IRS would create a better one on their own is plausible, but (really) far from certain.Two facts:1. H&R Block and the makers of TurboTax spent $6.6 million lobbying last year. They want to ban the IRS from offering its own free, simple tax filing service.2. Congress is about to pass a law doing exactly that. https://t.co/giatnNh5mD— Eric Umansky (@ericuman) April 9, 2019The IRS isn’t getting “banned” from anything. They voluntarily signed a non-compete 17 years ago, which they renewed less than six months ago. (And this is from a ProPublica editor!)The extent to which all Americans suffer an annual cost in time and money to protect the monopolies of TurboTax and H&R Block is astounding. Is there any issue where Congress is more out of step with citizen desires? https://t.co/GIRijGpS9Y— Garrett M. Graff (@vermontgmg) April 9, 2019Like, I get the desire for simpler taxes. But is $40 and 15 minutes really “suffering”? (And, again, for the lowest 70% of earners, they don’t even have to shell out the $40 if they don’t want to. Though I guess you could say that using existing FFP sites is a form of suffering, if in an excessively first-world sense.)Congress can’t muster the political will to eliminate the carried interest tax break for private equity titans, but it can get together to prevent free tax preparation for others: https://t.co/3pEfW8EPnF— Matt Taibbi (@mtaibbi) April 10, 2019No free preparation! Except for 70% of you! And a handful of other special classes!Anyway, I could go on. But the point is that if the goal is to get voters to hold politicians accountable, it would certainly help if the voters knew what was happening, and why, and where the real problems are.It’s difficult to see how all the current coverage supports such a cause.More Adventures in Water-MuddyingConsider this quote (from the original ProPublica piece, but re-used in several secondary articles):“This could be a disaster. It could be the final nail in the coffin of the idea of the IRS ever being able to create its own program,” said Mandi Matlock, a tax attorney who does work for the National Consumer Law Center.This is, um, pretty hyperbolic. Is there any justification for this? Does it aid clarity? Or does it just lend to the ever-marketable dynamics of sensationalism and conflict?Also consider the irreconcilable set of quotes in ProPublica’s sequel (published after lawmakers reacted to the first one).“The IRS chief counsel confirmed to his office that the Taxpayer First Act does not bar the agency from implementing a direct-file program.”“My staff pushed back on a long-standing policy that blocks the IRS from competing with private tax preparation companies […]”“Senate Republicans fit in some bitter pills and some problematic provisions,” said [Rep Katie Hill], who supported the bill as a whole, speaking on the House floor. “One of these is a piece that came to my attention today — which the corporate tax lobby has spent years and millions of dollars to get — which would bar the IRS from creating a simple, free filing system that would compete with their own.”I find this stuff infuriating, on three levels:Those who want to get quoted have biases and motives. Readers aren’t equipped to unpack those. Journalists need to do more than just “report the controversy”. Maybe that works for an AP news bulletin where speed is of the essence. But who is doing the work of coming in after and deconstructing for the reader why each party might have said what, and how their statements relate to their bios?Far too many journalists rely on services like HARO, where the experts are unknowns who respond to a call for a quote (vs. people with whom the journalist has an established relationship based on a keen understanding of competencies and incentives and likely spin). I know personally how low the bar is to getting quoted via HARO. I was never asked once to verify my identity or defend my position. What I said was just copied-and-pasted into a piece on the strength of a one-sentence self-supplied credential and my email address.Just because a politician has a quote doesn’t mean you should print it. It’s pretty clear that most who’ve commented on this legislation so far had/have (at best) a vague sense of what it contains, much less all the MOUs and external docs referenced in the bill. This isn’t uncommon. Only so many politicians have the right staff (and even then there are just hard limits on scope and priorities). Journalists ought to push back more to ensure that they aren’t just printing “um, I don’t reaaally know, but here’s my strong opinion that I’m told will play well to my base” quotes (or at least journalists need to carefully qualify those quotes when printing them).The Path ForwardI’ve written a lot over the past year about the failures of modern journalism — especially the hot-take/rapid-response/clickshare machine. There are things we can do to fix it, including some simple adjustments that could go a long way.In the absence of those changes, corporations like Intuit and H&R Block are going to have a field day. Their lobbyists will do what they’re paid very well to do, and our selective and ever-moving outrage will do nothing to solve the underlying problems. The MOU, whether law or policy, will continue to be enforced so poorly as to be one-sided, and tax innovation will be forever three or five years away.And so on and so on we’ll go, never to actually get anywhere, until we eventually decide that enough is enough, that the current model belongs in the dustbin of history, and that the time to make these changes is now.Note #1: I’m generally a fan of ProPublica. I thought their rundown last year was excellent, which has been true of a lot of their past coverage on this issue. I can’t really account for why this one missed the mark in relative terms.Note #2: An open question for any lawyer reading: could taxpayers sue the IRS for failing to meet the requirements set out in section 4.35 of the MOU (a promise to make “consistent, good faith efforts” to market the FFP)?

That would be my divorce. Judge Angela Arkin admitted to a bribe scheme in a Triple Paid Guardian Ad Litem Court Scam.You will not believe it unless you read actual law books: Read your state’s Introduction to the Rules of Professional Conduct available from your local law library. They will send it to you by email for a fee. You won’t be able to appreciate how deteriorated the courts are without reading actual law books….I started writing a book and realized I’d be slaughtered over it. So here’s a partially written chapter.6. Contempt of Court; Jail"You are going to jail," a friend predicted ominously, almost hysterically, more than a year earlier. "You'll be found in contempt of court."The harder the courts tried to socially isolate me through defamation, the harder I strived to communicate with the world. As part of my daily online effort I posted the police report from the domestic assault. With each document I posted online I shared whatever information I had about the courts and the way they operate. In all truthfulness, I did mention that the case was sealed now.Regardless, David Japha filed a Motion for Contempt of Court. His writing was purposely vague and ambivalent to open it to several interpretations. He didn't mention a particular Court Order or the way in which it might have been violated. There was naturally no reference to any law.His Motion stated that he asked me by email to take the police report offline and that I failed to do so.A few days before the Contempt of Court Advisory Hearing was to take place Virginia Fraser Able emailed me to say that David Japha and she cancelled the hearing. She was actually referring to the Permanent Orders Hearing scheduled for 5/18/2015. No one was ready for that hearing, I naively thought. We hadn't exchanged up to date financial disclosures or other documentation. It never occured to me that the Hearing would be held.When I read Virginia Fraser Able's email, therefore, I assumed that she was talking about the Contempt Hearing scheduled for 5/17/15 - just one day before. I spent a relaxed day at physical therapy. Upon my return I got a telephone message from a police officer. They said they had an arrest warrant against me for missing a court date and suggested that I show up the next day at 7am and get on the judge's docket.I was in the Courthouse at 7am the next day. Just for safety, I carried a folder with my medical records from my osteopath's office with me. It so happened that Judge _______________ had no hearings that day, Thursday. She was going to show up in the Courthouse until the next Monday. I was arrested and was to spend four days in jail. I had previously graduated from the Boulder City Citizen'sPoliceAcademy. I took tours of the Boulder County Jail and spend a day as a volunteer at the Douglas County Jail too. This training helped me now.In my mind, at the time, I was the innocent party. I was not in any kind of real trouble. I was living, so I imagined at the time, in a democracy that would protect my civil rights. The criminals are presiding. I approached jail time as a type of reality TV experience. I remembered Nelson Mandela. One must descend to the belly of the beast to understand the depth of societal corruption, I felt. So my time here won't be lost.Regardless, jail was tough. My coccyx was broken and I was under a doctor's orders not to seat on hard surfaces. A policewoman forced me to sit on a hard cement bench and I could feel my coccyx break again. I would have to embark on recovery from scratch when I left jail.Thankfully, I was referred to a jail nurse before being assigned to the Cherry pod, my cell and my bunk bed. The nurse gave me a questionnaire. I was asked whether I feared getting raped in jail. I took a deep breath of relief. My coccyx was broken. Regardless of any other disadvantages, discomforts and health threats brought about by rape, my coccyx would not have survived it. I might have ended up in surgery. This was not a good time for me to get raped. I later saw large signs in the jail pod: "Rape is Not Part of Your Sentence."The nurse went over the paperwork I brought. I complained that I was forced to sit on a hard surface. The policewoman was dismissive. He gave her a stern look and she didn't attempt this again. Otherwise there were not many provisions the nurse could make for me. I was going to get a lower bank bed. I suffered cold chronically because the glands regulating my temperature were injured. The jail was uncomfortably cold. Because my vertebrae were not fused, shivering was going to put damaging stress on the ruptured, slipped and bulging disk. I was not going to get extra blankets. I was given three pairs of sox which I could wear all at once.Four days were hard. I feared being exposed to impulsive individuals. I didn't have the muscles to fend off even a light push. The potential for injury was high. I preferred to stay in a temporary space. People stay there while they make arrangements for bail. The electronic doors were very loud and hurt my ears. My meal tasted like burnt car tires. I suspected it had to do with the rubber tray in which they were served. I elected to forgo jail meals and subsist on the bagged sandwiches people receive when they first arrive. This facility was a 23 hour lock-down facility. I soon developed a traumatic reaction to lock-down.On Monday I finally stood before Judge Slade. She was relaxed and smiling and conducted a lay conversations. All signs, I later learned, of an unrecorded hearing. I didn't know this was an Advisory Hearing. It wasn't mentioned. Whenever I tried to get the Register of Record for this case the clerks turned me down. I'm not sure what's behind it. In order to charge me in contempt of court David Japha reopened my husband's domestic assault case temporarily. As soon as my contempt of court case No. ___________ closed both were sealed. To this day I don't know what the official written record of my case states.I was not a flight risk. I lived less then 20 minutes from the courthouse in a house that I owned. But Judge Slade sent me back to jail and set a bail of $5000 "to cover attorney fees." Bail money is not intended for attorney fees. It is intended to ensure that the constituent shows up for their court date. This was definitely irregular, not to say unconstitutional. I had no intention of posting bail as I had no doubt I won't get the money back.Talking to other inmates a pattern emerged of judges illegally misappropriating bail money. It appears that employees of the Douglas County Human Services play into the financial interests of judges and attorneys. They double cross the inmates. One woman said she lost $2000 in bail money when an armed person stepped into Wendy's where she worked. She is a felon and may not possess weapons. She likely had no idea of what the written record of her case stated. Although the jail is in the Courthouse, inmates don't have access to their Register of Action. Electronic systems of communications exist in jail, but inmates can't defend themselves pro-se by filing pleadings electronically.I took the opportunity to educate myself onDrug Court. Drug Court appears to be nothing but a rue to generate as much litigation profits as possible. Constituents are dragged in and out of court to the point of homelessness. I suspect that the written record always parts from what constituents hear in court. Homeless people generate huge revenues to the court system. They regularly end up in jail. Several cities testify that they save tax money by providing homes for the homeless.Inmates shared that a program called Clean and Sober Home is a court-free, safe and helpful alternative toDrug Court. People actually get off drugs and get a chance to turn their lives around. I started propagating this information to as many inmates as I could speak to. When theWashingtonowner of the Clean and Sober Home was charged with drug possession I couldn't help but suspect that the courts were fighting back. I later explain the mechanisms by which judges work around the police to file false charges against constituents.Contempt of Court Hearings are when people use "objection, irrelevant," or "objection, this was merely a negotiation." I didn't bother to study the procedures. I suspect it would take quite a bit of studying. But in unrecorded hearings legal arguments are unlikely to change the results.When I arrived, handcuffed despite my skeletal injured, to my Contempt of Court Hearing (if that's what it was) my husband flatly admitted that he had already contacted the website that hosted the police report and was in a position to remove the posting himself.David Japha's choice of a writing technique that is purposely vague and uncommitted allowed Judge Slade to wonder from topic to topic trying to find some cause that I would consider reasonable for a contempt of court conviction. She wound around and around for a while. She was able to use clear sentences because, unlike David Japha's written pleading, the hearing was not recorded.The judge claimed that I got a letter in the mail advising me that it is contrary to court orders for me to post the police report online. She may have referred to a letter informing me that the case was now sealed in an envelope in the courthouse and not available for public searches. At the time of that hearing I assumed that a letter with an actual court order implicating me actually existed but that my husband received some of my mail to his new address due to sloppy work at USPS.Most of the discussion was lay. Finally, my husband's attorney got to conclude his position. He "concluded," not based on anything that had been demonstrated in court, that I'm habitually, continually and always ignoring court orders and violating them. I suspect that part of the hearing was recorded in full. The fact is that this was my first ever Contempt of Court hearing. Moreover, there were exactly zero court orders for me to follow in this case - which was my first encounter with the court system.The judge then made up her mind on how to proceed. She had previously agreed that I was not in knowledge of any court order or of a violation thereof. Knowingly violating a court order is a prerequisite for a contempt conviction. The Judge finally stated that since she is holding me to the standard of an attorney, being a pro-se party, she is waving that prerequisite and that I've been convicted.She sentenced me to 9 days in jail. At the time I had served 10, which meant that I could be released right away. The Judge said that she is scheduling another hearing. At that hearing I am to show the judge proof that I removed the posting. She would then expunge my misdemeanor conviction.The hardest thing about Douglas County Jail turned out to be the jail slippers. They didn't grip my feet and somehow by the time I left jail I suffered knee pains and forgot how to walk. I couldn't remember where my ankles go. I couldn't remember how to position my legs. I feared I would have to get knee surgery, but my osteopath showed me these were merely muscle pains. I started attending Reformer Pilates Integrated Physical Therapy three times a week. Walking was no longer an option for physical exercise. For the longest time I was either in bed or at Physical Therapy. Between my weekly osteopathy sessions and my three Physical Therapy sessions I started drawing close to $500 weekly from our HSA account.On a hunch, I decided to leave my mark on the written record of the case. I filed a Position Statement one day before the hearing. I was throwing as a curve ball to the judge as it takes 24 hours for the clerks to enter a pleading into the Register of Record. She would not be able to see my pleading before the hearing. My Position Statement clearly delineated my understanding of what happened in court, what my violation was, what I was ordered to do to comply, as well as the fact that my husband was in a position to remove the posting himself. Judge Slade turned a funny color when she saw my pleading. She accepted my proof of compliance and said she was expunging my misdemeanor. I still wonder what the case was really about. Whatever I heard it court - it was not it.It was around the time I got out of jail that an acquaintance told me that she's divorcing after 30 years of marriage. Her legal entitlements far exceeded what her husband offered, so she had commenced on litigation. I explained to her that the offer she got had more to do with the price of buying "justice" and less with any of our excellent Colorado Statutes or the Constitutions. She shared that her attorney advised her to avoid Magistrate Moss. He also suggested a GAL. Most intriguingly for me, he told her that this would be the excellent Judge Arkin's last season in court as she is expected to retire soon. Judge Arkin was not at retiring age.