Life Science Compliance Update

April 24, 2018

9th Aggregate Spend and Open Payments Conference

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On June 11th and 12th, 2018, the Ninth Aggregate Spend and Open Payments Conference will be held in Philadelphia, Pennsylvania at the Sonesta Philadelphia Hotel Rittenhouse Square.

The organizers of the event recognize the importance of transparency reporting and the moving pieces that are involved in aggregate reporting of compensation data to avoid any conflicts of interest. Organizers note that while compliance leaders do their best to reduce any discrepancies prior to the Physician Payments Sunshine Act reporting deadline, they still spend millions of dollars annually to manage reporting errors. In an effort to continue working on reducing reporting errors, this conference is held so that industry leaders come together and discuss strategies to minimize the errors and optimize current processes.

The Ninth Aggregate Spend and Open Payments Conference is the industry’s premier event for strategies to optimize transparency reporting for compliance programs. This event will bring together professionals from across the compliance landscape to discuss past submissions and upcoming changes to better prepare their company’s system.

Some of the key topics to be discussed during the two-day event include: how to uncover ways to optimize your organization’s aggregate data reporting processes; how to avoid violations within high-risk areas of compliance; how to comply with CMS documentation guidelines through tangible data analytic and management processes; how to effectively communicate with healthcare providers across national and global data reporting landscapes to ensure speaker program compliance; and how to consider frameworks for conducting internal audits designed to prioritize risks and measure success.

Some of the confirmed featured speakers include: Chairperson Frank Orlowski, Senior Director, Finance Leader Emerging Markets and Transition Sites (Retired), Pfizer; Ishita Arora, Compliance Manager, Horizon Pharma PLC; Elias Shamiyeh, Global Head of Project Management Transparency, Sanofi; Amie Phillips Pablo, Associate Director, Government Reporting, Novo Nordisk; Michael O’Connor, Former Senior Director, Global Head Compliance and Ethics Operations, Alexion Pharmaceuticals; Derek Devgun, Legal Director, Restorative Therapies Group, Medtronic; and Ann N. James, Ph.D., J.D., Senior Research Compliance Contract Manager, Research Management Group, School of Medicine, Stanford University.

If you are interested in attending, you can register here or by calling (866) 207-6528.Those who register by Friday, May 4, 2018, will receive the early bird pricing rate of $1,895 per person, a $200 discount. There are group discounts available.

April 10, 2018

The Day After Tomorrow – The Drug Pricing Transparency Chorus Grows Louder

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Drug pricing transparency, as a concept at least, is here to stay. However, the details of what that means and the new obligations that pharmaceutical companies will need to deal with are yet to be determined. For pharmaceutical compliance professionals, 2018 will continue to be a time of high uncertainty and an ever-increasing workload. This article examines the current state and what the future may hold.

Breaking with the tradition of past Food and Drug Administration (“FDA”) heads, Dr. Scott Gottlieb continues to speak out on drug pricing and competition; topics usually considered outside of the Commissioner’s purview. However, Dr. Gottlieb is not alone.

The chorus of advocates calling for transparency in drug pricing transparency has rapidly grown from citizen activists and academics to legislators at all levels of government and now the FDA Commissioner. What is remarkable is the uniformity of their reasoning why transparency is necessary and the disparity of their ideas of what drug pricing transparency looks like.

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March 28, 2018

FDA Transparency Blueprint Issued

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Most everyone even tangentially related to the pharmaceutical industry knows and understands that right now, transparency is a hot topic. In Winter 2017, The Journal of Law, Medicine & Ethics published a Special Supplement to Volume 45:4, a written companion to a January 16, 2018 symposium entitled, “Blueprint for Transparency at the U.S. Food and Drug Administration.”

According to the Letter from the Editor included in the Special Supplement, “guest editors Anna L. Davis, James Dabney Miller, Joshua M. Sharfstein, and Aaron S. Kesselheim and their co-authors have tackled the challenging topic of transparency at the respected government agency. A team of researchers from various universities wrote the main “Blueprint” article of this supplement issue, which is followed by six commentary articles.”

This blueprint includes a lengthy article written by a group of authors, with the subtitle, “Recommendations to Advance the Development of Safe and Effective Medical Products.” The Blueprint article recommends eighteen specific ways the FDA can be more transparent so that the public at large can be better informed about medical products, applications, and scientific studies.

The recommendations were all separated into five different “focus areas,” including: (1) the FDA should disclose more information about key milestones in the application process; (2) the FDA should disclose more of its own analysis and decision-making; (3) the FDA should disclose more about the application and review process for generic drugs and biosimilar; (4) the FDA should correct misleading information in the market; and (5) the FDA should disclose data from scientific studies to enhance understanding of medical products.

Some of the more specific recommendations include:

  • FDA should include in disclosures of investigational notices and marketing applications the class of medication and mechanism of action if known.
  • When FDA has issued or released a clinical hold related to safety or efficacy, the FDA should release a summary of the reasons within 10 days.
  • FDA should disclose whether a marketing application has been designated for an expedited development or review program and, if so, provide the scientific basis for that designation.
  • FDA should disclose written requests for pediatric studies at the time such requests are made, as well as other documents indicating agreement on changes to the initial request.
  • FDA should make public its clinical and statistical reviews of products not approved or for which the marketing applications are abandoned or withdrawn. FDA should issue guidance on the definition of abandonment.
  • FDA should make its pooled data sets, masked and de-identified as appropriate, and FDA’s analyses of these data sets, available to the medical and research community through clinical data repositories, such as through the National Institutes of Health Biologic Specimen and Data Repository Information Coordinating Center.
  • FDA should routinely disclose those portions of Complete Response Letters to generic drug manufacturers that relate to bioequivalence.
  • FDA should routinely disclose the filing of abbreviated biologics licensing applications, including the name of the sponsor, the reference biologic product, and whether the application is for “biosimilarity” or “‘interchangeability.”
  • FDA should correct misleading information where there is the potential for substantial confusion about the safety or efficacy of the medical product for both approved and unapproved uses.
  • FDA should disclose Clinical Study Reports that have been submitted to FDA in support of a marketing application. To the extent possible, FDA should harmonize standards on CSR release with the European Medicines Agency.
  • When there are clinical trial data, including patient-level data, that are not available to independent investigators through industry-sponsored websites, then FDA should make data available through clinical data repositories, such as through the National Institutes of Health Biologic Specimen and Data Repository Information Coordinating Center, with policies on deidentification to protect patient privacy.

The ultimate goal of the publishers of the article, the Special Supplement, and the symposium is for the FDA to disclose more throughout its review process, and do so without disrupting trade secrecy protections, in order to improve the public’s health.

While these recommendations have not been sanctioned or acknowledged by the FDA, it is still important to review them and be aware of the suggestions and the “publication blitz” (see here, here, here, here, and here, just to name a few) the authors of the study did.

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