Here is the link to the uncorrected pre-publication proofs of The Future of Drug Safety: Promoting and Protecting the Health of the Public, the Institute of Medicine's long anticipated report on the FDA and the drug approval process. (200+ page PDF) It will cost you significant dollars to buy the typo-free version once it comes out, so if you're a health policy junky, this will save you enough for a trip to Dunkin' Donuts, or preferably the produce aisle.
The key recommendations, as usual, are another open door crashed through. If you've been reading this space, you know that everything they say has been said before by health care policy drones in every corner of the land. But that's how it works -- once the grunts, laboring in their anonymity, break the door down, the brass can stroll in and find themselves shocked, shocked, at what goes on here. Some highlights:
- (Ooh, this is a good one!)3.3: The committee recommends the Secretary of HHS direct the FDA commissioner and Director of CDER [Center for Drug Evaluation Research], with the assistance of the Management Advisory Board, to develop a comprehensive strategy for sustained cultural change that positions the agency to fulfill its mission, including protecting the health of the public. (Damn, that's nasty.)
- 3.5: To restore appropriate balance between the FDA’s dual goals of speeding access to innovative drugs and ensuring drug safety over the product’s lifecycle, the committee recommends that Congress should introduce specific safety-related performance goals in the Prescription Drug User Fee Act IV in 2007.(Whoops! guess they forgot a teeny weeny little item last time. Well, those Congress people have a lot to think about, what with having to raise money and all . . .
- 4.1: The committee recommends that in order to improve the generation of new safety signals and hypotheses, CDER (a) conduct a systematic, scientific review of the AERS [Adverse Event Reporting System] system , (b) identify and implement changes in key factors that could lead to a more efficient system, and (c) systematically implement statistical-surveillance methods on a regular and routine basis for the automated generation of new safety signals.
- In addition, CDER’s ability to test drug safety hypotheses is limited. Wait a minute -- isn't that supposed to be, like, their job? I keep getting the feeling that I'm missing something here . . .
4.2: The committee recommends that in order to facilitate the formulation and testing of drug safety hypotheses, CDER (a) increase their intramural and extramural programs that access and study data from large automated healthcare databases and (b) include in these programs studies on drug utilization patterns and background incidence rates for adverse events of interest, and (c) develop and implement active surveillance of specific drugs and diseases as needed in a variety of settings. In other words, they should start to collect the actual data that would be necessary in order to evaluate drug safety. Golly, that does sound like a good idea.
And so it goes, with a whole series of recommendations that just make me say, "Well duhhhhh." Shorter IOM:
The FDA needs to develop the intention and the ability to protect the public. Neither of which it currently has.
(Thanks to Badri for the tip.)