The Future of Drug Safety: Promoting and Protecting the Health of the Public - Institute of Medicine

The Future of Drug Safety: Promoting and Protecting the Health of the Public - Institute of Medicine:

"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......

"During its research, the committee found that

1. There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry.
2. 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.
3. 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.
4. 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."

Read the Washington Post story triggered by the release of the study.

Comment: This suggests problems in the knowledge base and the way knowledge is used in the drug safety process in the United States that probably go beyond the Bush Administration's unwillingness to listen to the science if it conflicts with their ideology. I suspect that the FDA could do better now than ever before in assuring drug safety because of the improvements that have taken place in the National Information Infrastructure. We can now link together doctors into a national reporting system and create data bases of drug trials in ways not possible in the past. Unfortunately, I suspect that the pressures of the industry to simplify regulatory processes, and the responsiveness of politicians to such pressures may militate against the FDA doing the best job possible for the public.

If there are problems of this kind in the United States of America, I suspect that they are much worse in developing nations. Most poor countries depend on the drug safety processes of the OECD nations to give them warnings of possible dangers. However, we increasing recognize that genetic differences exist in the response to disease agents and drugs, as well as the likelihood of metabolic and other non-communicable diseases. A genetically based pharmaceutical problem that affects one in a thousand persons in Western Europe or the United States may affect a much larger or even smaller portion of the population in Africa or Asia. Developing nations also should be worried about the problems identified in this U.S. Institute of Medicine study.