In response to growing public concern with health risks posed by approved drugs, U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services announced a series of steps to address drug safety, including asking the IOM to convene a committee to assess the U.S. drug safety system and to make recommendations to improve risk assessment, surveillance, and the safe use of drugs.
In its report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, the committee considered the drug safety system as the sum of all activities conducted by FDA and other stakeholders to monitor, evaluate, improve, and ensure drug safety.
Although much of the committee's work was focused around the drug review, safety surveillance, and related activities of the Center for Drug Evaluation and Research (CDER), the committee also reviewed some key aspects of the roles and considered the potential contributions of the pharmaceutical industry, the academic research enterprise, Congress, the health care delivery system, patients and the public.
During its research, the committee found that
- There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry.
- Most stakeholders--the agency, the industry, consumer organizations, Congress, professional societies, health care entities--appear to agree on the need for certain improvements in the system.
- The drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement.
- FDA and the pharmaceutical industry do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.
Noting that resources and therefore efforts to monitor medications' risk-benefit profiles taper off after approval, the committee that wrote the report offered a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
- Labeling requirements and advertising limits for new medications
- Clarified authority and additional enforcement tools for the agency
- Clarification of FDA's role in gathering and communicating additional information on marketed products' risks and benefits
- Mandatory registration of clinical trial results to facilitate public access to drug safety information
- An increased role for FDA's drug safety staff
- A large boost in funding and staffing for the agency