Sign in Subscribe
Pharmaceutical industry

FDA's Post-Approval Study Mandate: A Critical Gap in Regulatory Compliance

Strategic Insights

— 1 min read

Congress is exploring the authority to grant the FDA the power to mandate post-approval studies of drugs, following the recent recall of Vioxx and other medications. This move aims to address concerns over the safety and efficacy of pharmaceuticals. FDA experts and industry professionals emphasize the need for rigorous post-marketing safety surveillance to prevent litigation and ensure regulatory compliance.

Key Takeaways:

  • The FDA lacks authority to mandate post-approval studies, despite the growing concerns over drug safety and efficacy.
  • A clinical trial of 3,000 people is insufficient to reveal rare adverse events, which can occur in 0.1% of the population.
  • Post-marketing safety surveillance is essential to prevent costly litigation and ensure public safety.
  • Industry professionals advocate for rigorous post-marketing safety surveillance, vigorous IRB oversight in the clinical stage, and support for accredited IRBs.
  • Pharmaceutical companies must implement effective post-marketing study surveillance and comply with regulatory requirements to avoid litigation and penalties.
  • The HHS Office of Inspector General plans to update the review of compliance with post-marketing study commitments and FDA oversight in 2005.
  • Pharmaceutical companies must stay current on evolving pre-emption law and policy, as changing requirements demand unprecedented vigilance throughout sponsor organizations.

Statistics:

  • To show a rate difference from 0.01% to 0.03%, a sample size of 175,000 people would be required, with a potentially affected group of 800.
  • To show a rate difference from 0.01% to 0.02%, a sample size of 500,000 people would be required, with a potentially affected group of 400.
  • 5 "Dear Doctor" letters, press releases, postings on the Janssen and FDA websites, inclusion in national pharmacy databases, direct notices to large pharmacy chains, and face-to face visits by detail people were conducted to inform doctors about possible adverse events for Propulsid.
  • In the Vioxx case, some patients who used the drug for more than 18 months had an increased risk of heart attack and stroke.

Sources:

  • Dec. 2 "Washington Post" op-ed by William Schultz, former FDA Deputy Commissioner for Policy.
  • FDLI conference address by Lourdes Frau, M.D., former global head of pharmacovigilance and epidemiology at Aventis Pharmaceuticals.
  • FDLI speech by Hector Izurieta, M.D., of the Division of Epidemiology in FDA's Center for Biologics.
  • FDLI presentation by Sol Weiss, esquire, Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley, P.C.
  • FDLI speech by Mathew Van Hook, senior counsel at the law firm Holland & Knight.

Read more