Wednesday, January 26, 2005

Perspective on the FDA

The US Food and Drug Administration has been in the spotlight lately.  The one article that is likely to have the most influence is the one posted by the New England Journal of Medicine recently.  It is not open access, but here are some excerpts.
Today's FDA
Eve E. Slater, M.D.
January 20, 2005

The Food and Drug Administration (FDA) is responsible for the safety and efficacy of most food products and all human and veterinary drugs, biologic products, medical devices, cosmetics, and products emitting radiation that are sold within U.S. borders — a list that accounts for an estimated 20 percent of consumer spending, valued at approximately $1.5 trillion. [...] 
That gives us the background, highlighting the enormous significance of the work of the Agency.  Dr. Slater goes on to mention the impact of the the Prescription Drug User Fee Act (of 1992), the FDA Modernization Act of (1997), and the Public Health Security and Bioterrorism Preparedness and Response Act of (2002).  She notes also the fact that the agency has almost doubled in size since 1992, and that about 18% of their funding now comes from user fees.  She points out that the agency has made progress in reducing the time required for premarketing review and approval of new medications.  Despite this, the time that elapses, on average, between the discovery of a new drug, and its subsequent marketing, has increased.  This is due to scientific and technical issues; not regulation. 

Dr. Slater informs us that there has not been stability of leadership at the FDA:
Evolving FDA regulations have prompted the pharmaceutical industry to develop a powerful infrastructure in order to allow timely compliance in a highly competitive environment, whereas the growth in infrastructure at the FDA has lagged behind. This has often resulted in an imbalance when the FDA has attempted to counter industry assertions during negotiations over the approval or labeling of drugs. The problem has been seemingly compounded by several interruptions in FDA leadership. Since 1980, the FDA commissioner has been appointed by the president, subject to confirmation by the Senate. Almost two years have elapsed between the tenures of the past three commissioners, each with distinguished credentials, and the position has been vacant since March 2004 — a problem that is reflective of the political process and stands in contrast to certain overseas regulatory bodies in which heads of agencies serve fixed terms. Thus, the FDA has lacked a continuous voice to articulate policy, advise Congress, and inform the public.
In simpler terms, what she is saying is that the FDA sometimes has problems in negotiations with industry regarding the marketing of drugs.  Many people do not know how much negotiation takes place.  For example, the FDA may recommend a particular warning, or want more testing.  The pharmaceutical company will listen to the proposal, and come back with a counterproposal, and basically they duke it out until some kind of compromise is reached.  Since industry has a bigger team, with more money, the FDA may have difficulty conducting these negotiations from a position of strength.  Also, she implies that there is a problem with the fact that the office of the FDA commissioner is filled by political appointment.  Despite the key role of the office, it has been vacant now for almost a year!

Dr. Slater concludes with commentary about post-marketing surveillance (monitoring for problems, after a drug is released on the market), dissemination of information about risk, and the potential role of the FDA in managing the cost of pharmaceutical prices.  She also includes some recommendations, which seem like good ideas.  Specifically, she would like to see improved post-marketing surveillance, better data collection for public health purposes, and improvements in systems to reduce medication errors:
[T]he FDA has available to it a wealth of information from placebo control groups, which, if compiled, could provide one of the largest comparative epidemiologic databases. The announced transition to nationwide computer-assisted prescribing of bar-coded medications must proceed promptly to provide an electronic template for the rapid linking of events to prescriptions. Finally, the FDA must more readily prosecute lapses in the reporting of adverse events and enforce penalties for failure to complete post-approval studies.
Although there would be substantial costs involved in implementing these suggestions, she points out that there would be significant savings as well.  Her conclusion:
Debate about the relationship between the FDA and the pharmaceutical industry is healthy, but the discussion should expand to consider the true potential of the FDA. It is not merely a matter of too fast or too slow, of too many or too few regulations, or of Democrat or Republican solutions. We must envision the FDA as more than a counterpart to the pharmaceutical industry. It is time for the agency to realize its full potential as both protector and promoter of the public health.
Of course, the notion that any reforms could take place in a nonpartisan effort probably is unrealistic.  I just hope that if some of these reforms are debated in Congress, that the industry representatives could exercise some restraint in their lobbying efforts.  The industry must have a voice, to be sure, but these issues are too important to let any one group dictate the terms of the debate.