Post-Vioxx Report: Experts Fault FDA for Unsafe Drugs, Call for Center for Drug Safety

Tuesday, Christopher Lee of the Washington Post reported that five expert FDA advisors involved in the Drug Safety and Risk Management Advisory committee have charged that the Agency doesn't adequately protect the public from unsafe drugs. Among their criticisms:
  • Current procedures can miss serious problems, both before and after approval
  • FDA currently doesn't have the legal authority to pull potentially dangerous drugs, force changes in drug labels or sanction drug companies for lax monitoring.
  • The Agency still can't insulate itself from the influence of drug manufacturers.
The experts suggest the following:
  • Ban advertising for newly approved drugs until they've been available long enough for problems to show up
  • Empower FDA to fine drugmakers for lax pharmacovigilance
  • Expand the types of experts on drug data review panels
The experts also called for the establishment of a Center for Drug Safety outside of the CDER and increased FDA funding for safety monitoring, through a nominal fee on each prescription.  To read the article, click here. Below is the abstract of the report:  The FDA and Drug Safety A Proposal for Sweeping Changes Curt D. Furberg, MD, PhD; Arthur A. Levin, MPH; Peter A. Gross, MD; Robyn S. Shapiro, JD; Brian L. Strom, MD, MPH Arch Intern Med. 2006;166:1938-1942. The current Food and Drug Administration (FDA) system of regulatingdrug safety has serious limitations and is in need of changes.The major problems include the following: the design of initialpreapproval studies lets uncommon, serious adverse events goundetected; massive underreporting of adverse events to theFDA postmarketing surveillance system reduces the ability toquantify risk accurately; manufacturers do not fulfill the majorityof their postmarketing safety study commitments; the FDA lacksauthority to pursue sponsors who violate regulations and ignorepostmarketing safety study commitments; the public increasinglyperceives the FDA as having become too close to the regulatedpharmaceutical industry; the FDA's safety oversight structureis suboptimal; and the FDA's expertise and resources in drugsafety and public health are limited. To address these problems,we urge Congress, which is ultimately responsible for the FDA'sperformance, to implement the following 5 recommendations: (1)give the FDA more direct legal authority to pursue violations,(2) authorize the adoption of a conditional drug approval policy,at least for selected drugs, (3) provide additional financialresources to support the safety operations, (4) mandate a reorganizationof the agency with emphasis on strengthening the evaluationand proactive monitoring of drug safety, and (5) require broaderrepresentation of safety experts on the FDA's advisory committees.
Author Affiliations: Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC (Dr Furberg); Center for Medical Consumers, New York, NY (Mr Levin); Departments of Internal Medicine, Hackensack University Medical Center, Hackensack, NJ, and New Jersey Medical School, University of Medicine and Dentistry of New Jersey, Newark (Dr Gross); Center for the Study of Bioethics, Medical College of Wisconsin, Milwaukee (Dr Shapiro); and Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, and Center for Education and Research in Therapeutics, University of Pennsylvania School of Medicine, Philadelphia (Mr Strom).