1. Sponsor an Institute of Medicine (IOM) Study of the Drug Safety System
An IOM committee, under an FDA contract, will study the effectiveness of the United States drug safety system with emphasis on 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 committee will examine 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.
2. Implement a Program for Adjudicating Differences of Professional Opinion
CDER [the FDA's Center for Drug Evaluation and Research] will formalize a program to provide an improved process to ensure that the opinions of scientific reviewers are incorporated into its decision-making process. In most cases, free and open discussion of scientific issues among review teams, and with supervisors, managers and external advisors, leads to an agreed course of action. Sometimes, however, a consensus decision cannot be reached, and an employee may feel that his or her opinion was not adequately considered.
Such disagreements can have a potentially significant public health impact, so 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.
3. Appoint Director, 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. The Center is seeking a candidate who is a nationally recognized drug safety expert with knowledge of the basic science of drug development and surveillance, and has a strong commitment to the protection of public health.
4. Conduct 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. Examples of input that might be sought include whether a particular safety concern alters the risk to benefit balance of a drug; whether FDA should request a sponsor to conduct a particular type of study to further address an issue; what types of studies would best answer the question; whether a finding is unique to one product or seems to be a drug class effect; whether a labeling change is warranted and, if so, what type, and how to otherwise facilitate careful and informed use of a drug.
These consultations will include experts from FDA, other federal agencies, academia, the pharmaceutical industry and the healthcare community.
5. Publish Risk Management Guidances
By the end of this year, FDA intends to publish final versions of three guidances that have been developed by our 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 steps come late in a turbulent year for the FDA, which has increasingly struggled to respond to criticisms from the public, the media (including medical journals), Congress, and its own scientists on a range of issues:
- The FDA's May 6 decision, going against its own advisory committee, to reject the application to make Plan B, an emergency contraceptive, available over-the-counter (rather than restricted to prescription use), a move widely regarded as politically motivated rather than based in science (see Washington Post story)
- The FDA's slow response to mounting concerns about the safety and suicide risk of antidepressants in children and adolescents (see CNN story)
- The flu vaccine shortage, where the FDA was apparently caught off guard by problems identified by British regulators at Chiron's vaccine production facility (see Washington Post story)
The growing controversy around the FDA's role and competence has been compounded by a perception that the agency is biased towards protecting the interests of the pharmaceutical industry over patients and the public health. Such bias would align the agency firmly with the positions of the Bush White House, and indeed the FDA has played an unusually prominent and outspoken role in opposing re-importation of medicines from Canada.
The agency's strident opposition to drug re-importation based on supposed concerns about drug safety echo the rhetoric of the pharmaceutical industry and the Bush administration. The FDA has made little headway in the re-importation debates and -- like the Plan B debacle -- threaten to tarnish the agency's image further as having let partisan politics override science. This danger is evident when the FDA's Acting Commissioner, Dr. Lester Crawford, suggested in an interview in August that terrorists might exploit drug re-importation to poison Americans (see AP story).
Dr. Crawford, by training a veterinarian, has been acting commissioner since the former commissioner appointed by Bush, Dr. Mark McClellan, took over as head of the Centers for Medicare and Medicaid Services (CMS) in March. Most observers expected a new, permanent commissioner to be appointed after the elections, though the Pink Sheet Daily is reporting that Thomas Scully, former CMS administrator, is predicting that the White House will leave Dr. Crawford in his current position and not seek other candidates.
What's clear is that the FDA needs to reorient itself and reassert its ability to protect the nation's health through effective regulation of drugs. Until the FDA can restore its credibility, continued scrutiny will mar not only the agency's reputation, but the public's confidence in our medicines.