FDA moves to strengthen drug safety program

The FDA announced in early November that it was strengthening its safety program for marketed drugs. Lester M. Crawford, DVM, PhD, acting FDA commissioner, says that he has authorized the Center for Drug Evaluation and Research (CDER) to take the following measures:

  • Sponsoring an Institute of Medicine (IOM) study of the drug safety system. The study will emphasize the post-market phase, and assess what additional steps could be taken to learn more about the side effects of drugs as they are actually used. The IOM committee will examine the FDA’s role within the health care delivery system and recommend measures to enhance the confidence of Americans in the safety and effectiveness of their drugs.
  • Implementing a program for adjudicating differences of professional opinion. CDER will formalize a program to provide an improved process to ensure that the opinions of scientific reviewers are incorporated into its decision-making process. CDER’s program provides for a review of the involved differing professional opinions by FDA and outside experts. An ad hoc panel, whose members were not directly involved in disputed decisions, will have 30 days to review all relevant materials and recommend to the center director an appropriate course of action.
  • Appointing a director for the Office of Drug Safety. CDER will conduct a national search to fill the currently vacant position of director of the Office of Drug Safety, which is responsible for overseeing the post-marketing safety program for all drugs.
  • Conducting drug safety/risk management consultations. In the coming year, CDER will conduct workshops and advisory committee meetings to discuss complex drug safety and risk management issues. These may include emerging concerns for products that are investigational or already marketed. These consultations will include experts from the FDA, other federal agencies, academia, the pharmaceutical industry, and the health care community.
  • Publishing risk management guidances. By the end of this year, the FDA intends to publish final versions of three guidances that have been developed by the agency to help pharmaceutical firms manage risks involving drugs and biological products. These documents are "Premarketing Guidance," covering risk assessment of pharmaceuticals prior to their marketing; "RiskMAP Guidance," which deals with the development and use of risk-minimization action plans; and "Pharmacovigilance Guidance," which discusses post-marketing risk assessment, good pharmacovigilance practices, and pharmacoepidemiologic assessment. These guidances, which were first issued as draft guidances in May 2004, are designed to assist manufacturers in the management and minimization of risks of pharmaceutical products throughout their life cycle.