Postmarketing Surveillance – An Imperfect System

The FDA does not and cannot guarantee that all the medical treatments it approves are safe and effective. Thus, it is left to the postmarketing period to identify inferior products, especially those that have deadly side effects. Finding and removing inferior products falls to FDA's post marketing surveillance (PMS) program, but unfortunately the current system is inadequate. The PMS relies primarily on the lowest level of research methods — case reports, which are sent to the agency where they are analyzed and remedial steps taken if the evaluation shows there is an unanticipated problem. However, it was taking the FDA too long to identify a significant problem and decide what to do about it and in the interval; people were suffering and dying needlessly. There were numerous suggestions on how to improve the system, but FDA's response tends to be judged as unresponsive by its critics. To meet the postmarketing challenge the FDA needs the authority to require (1) independent teams to investigate serious adverse reactions; (2) the use of cohort studies to monitor the performance of newly approved drugs and (3) the employment of clinical trials to investigate unresolved efficacy and safety issues.

Keywords

Adverse reaction drug labeling drug safety market withdrawal postmarketing surveillance 

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Chapter 24 — Postmarketing Surveillance

Cited References

  1. Bennett C, Nebeker J, Lyons E, et al. The research on adverse drug events and reports (RADAR) project. JAMA 2005:293;2131–2140.PubMedCrossRefGoogle Scholar
  2. Committee on the Assessment of the US Drug Safety System. The Future of drug safety. Institute of Medicine. http://www.iom.edu/CMS/3793/26341/37329.aspx Sep 22, 2006.
  3. Editorial. Half a step on drug safety. New York Times Feb 17, 2005:A28.Google Scholar
  4. Food and Drug Administration. The Future of drug safety —promoting and protecting the health of the public FDA's response to the Institute of Medicine's 2006 Report. http://www.fda.gov/oc/reports/iom013007.html Jan 30, 2007.
  5. Furberg C, Levin A, Gross P, et al. The FDA and drug safety. A proposal for sweeping changes. Arch Intern Med 2006:166;1938–1942.PubMedCrossRefGoogle Scholar
  6. General Accounting Office. Drug safety improvements needed in FDA's postmarketing oversight process. http://209.85.165.104/search?q=cache:537MckWKkJIJ:www.gao.gov/ Mar 25, 2006.
  7. Health and Human Services, Office of Inspector General. FDA review process for New Drug Applications (OEI-01-01-00590) Mar 2003.Google Scholar
  8. Lasser K, Allen P, Woolhandler S. Timing of new black box warnings and withdrawals for prescribing medicines. JAMA 2002:287;2215–2220.PubMedCrossRefGoogle Scholar
  9. Mangano D, Tudo J, Dietzel C. The risk associated with Aprotinin in cardiac surgery. N Engl J Med 2006:54;353–365.CrossRefGoogle Scholar
  10. Moore T, Psaty B, Furberg C. Time to act on drug safety. JAMA 1998:279;1571–1573.PubMedCrossRefGoogle Scholar
  11. Olson M. Pharmaceutical policy change and the safety of new drugs. J Law and Econ 2002:45; 615–616.CrossRefGoogle Scholar
  12. Shah R. Can pharmacogenetics help rescue drugs withdrawn from the market? Pharmacogenomics 2006:7;889–908.PubMedCrossRefGoogle Scholar
  13. Smith S. Sidelining safety — the FDA's inadequate response to the IOM. New Engl J Med 2007:357;960–963.PubMedCrossRefGoogle Scholar
  14. Union of Concerned Scientists. FDA scientists pressured to exclude, alter findings; scientists fear retaliation for voicing safety concerns. http://www.ucsusa.org/news/press_release/fda-scien-tists-pressured.html. July 20, 2006.
  15. Vlahakes G. The value of phase 4 testing. N Engl J Med 2006:54;413–415.CrossRefGoogle Scholar
  16. Willman D. How a new policy led to seven deadly drugs. Los Angeles Times Dec 20, 2000:A1.Google Scholar
  17. Wood A, Stein C, Woosley R. Making medicines safer — the need for an independent drug safety board. N Engl J Med 1998:339;1851–1855.PubMedCrossRefGoogle Scholar

General References

  1. Agency for Healthcare Research and Quality. CERTS overview. http://www.ahrq.gov/clinic/certs-ovr.htm Feb, 2007.
  2. Centers for Education and Research on Therapeutics (CERTs). Risk assessment of drugs, biolog-ics and therapeutic devices: present and future issues. Pharmacoepidemiol Drug Saf 2003:2;653–662.Google Scholar
  3. Fontanarosa F, Rennie D, DeAngelis C. Postmarketing surveillance — lack of vigilance, lack of trust. JAMA 2004:292;2647–2650.PubMedCrossRefGoogle Scholar
  4. Food and Drug Administration. Postmarketing surveillance programs. http://www.fda.gov/cder/regulatory/applications/postmarketing/surveillancepost.htm Apr 9, 2004.
  5. Gardner A. Experts urge major FDA overhaul. Live Science. http://www.livescience.com/health-day/535418.html Oct 10, 2006.
  6. Gottlieb S. Opening pandora's pillbox: using modern information tools to improve drug safety. Health Affair 2005:24;938–948.CrossRefGoogle Scholar
  7. Harris G. F.D.A. to create advisory board on drug safety. New York Times Feb 16, 2005:A1.Google Scholar
  8. Harris G. F.D.A. widens safety reviews on new drugs. New York Times Jan 31, 2007:A17.Google Scholar
  9. Kaufman M. Many workers call FDA inadequate at monitoring drugs. Washington Post Dec 17, 2004:A8.Google Scholar
  10. Kramer B, Wilentz J, Alexander D, et al. Getting it right: being smarter about clinical trials. PLoS Med 2006:3;e144.PubMedCrossRefGoogle Scholar
  11. MacPherson K. MDs ring the alarm on safety of drugs. The Newark Star Ledger Oct 10, 2006:2C.Google Scholar
  12. Psaty B, Furberg C, Ray W, et al. Potential for conflict of interest in the evaluation of suspected adverse drug reactions. JAMA 2004:292;2622–2631.PubMedCrossRefGoogle Scholar
  13. Ray W, Stein C. Reform of drug regulation – beyond an independent drug-safety board. New Engl J Med 2006:354;94–201.CrossRefGoogle Scholar
  14. Siebenaler J. FDA postmarketing commitment studies. Regulatory Affairs Focus Magazine Archives. http://www.raps.org/s_raps/rafocus_article.asp?TRACKID=&CID=61&DID=27043 Apr 15, 2006.
  15. Trontell A. Expecting the unexpected-drug safety, pharmacovigilance, and the prepared mind. New Engl J Med 2004:351;1385–1387.PubMedCrossRefGoogle Scholar
  16. World Health Organization. The importance of pharmacovigilance - safety monitoring of medicinal products. http://www.who.int/medicinedocs/en/d/Js4893e/#Js4893e.1 Dec 21, 2002.

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