NCHR’s Comments on FDA’s Best Practices in Drug and Biological Product Postmarket Safety Surveillance

National Center for Health Research, January 3, 2020

National Center for Health Research Public Comments on FDA’s Best Practices in Drug and Biological Product Postmarket Safety Surveillance for Food and Drug Administration Staff; Draft Document; Availability; Establishment of Public Docket; Request for Comments
[FDA-2019-N-3768]

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety.  We do not accept funding from companies that make products that are the subject of our work.

Although this draft document entitled “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff” seems to be a description of the status quo rather than proposing any changes, we note that this document lacks some essential information:

  • The document notes that FAERS reports are often incomplete, stating that “The quality of information provided in the ICSRs is highly variable.”  However, it does not mention that the quality of these reports has deteriorated in recent years, with even basic information such as age and gender now missing from about half of manufacturer reports.1,2
  • It describes how FAERS reports are supposed to be screened, but does not mention that manufacturer adverse event reporting requirements have not been updated for almost two decades.
  • It provides only a single paragraph to discuss the additional post-marketing studies required of manufacturers.  It does not provide any information about enforcement for these studies or about the poor industry compliance in completing the studies as promised in terms of diversity of patients, follow-up rates, or timeliness.3
  • Similarly, the document only devotes a single paragraph to the FDA’s Sentinel Initiative, despite its importance.
  • The FDA is supposed to post new safety information and potential signals on a quarterly basis.4  Unfortunately, only rarely does the FDA resolve the signals to indicate anything beyond “The FDA is evaluating the need for regulatory action.”

Thank you for the opportunity to comment on this draft document describing FDA’s practices for postmarket safety surveillance by FDA staff.

National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.

References

  1. Moore TJ, Furberg CD, Mattison DR, Cohen MR. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. Pharmacoepidemiology and Drug Safety. 2016;25(6):713-718. https://onlinelibrary.wiley.com/doi/abs/10.1002/pds.3979
  2. Institute for Safe Medication Practices. A Critique of a Key Drug Safety Reporting System. Quarter Watch. Jan 2015. https://www.ismp.org/quarterwatch/drug-safety-reporting-system
  3. Woloshin S, Schwartz LM, White B, Moore TJ. The Fate of FDA Postapproval Studies. New England Journal of Medicine. 2017;377(12):1114-1117. https://www.nejm.org/doi/full/10.1056/NEJMp1705800
  4. U.S. Food and Drug Administration. Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS). https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event-reporting-system