This year, Senators Charles Grassley (R-Iowa) and Max Baucus (D-Mont) have been on more of a tear than usual regarding the FDA. A lot of their focus this year has been on post-marketing surveillance of drugs and devices. They are concerned with drug safety, but not benefit.
In November 2006, the Breckenridge Institute issued a report that was not available to the public, but which contained an independent review of the system used by the FDA to conduct such surveillance. A partial copy of the Breckenridge report is available. Senators Grassley and Baucus issued a letter to the FDA asking that the agency account for the findings of the report.
Then in late May, Avandia hit the fandia. The Finance co-chairmen were once again in touch with the FDA sending a memorandum demanding answers about FDA’s handling of Avandia. On Thursday, May 24, Senator Grassley made a statement on the floor, asking why a black box warning had not been put on Avandia by the FDA. This is despite the fact that no one knows what the effect of a black box warning really is on prescribing practices. Still, apparently, this action would have made the Senator feel better.
On Friday, the two Senators introduced new legislation – The Access to Medicare Data Act of 2007 - that would give researchers at federal agencies and university-based and other research organizations highly controlled access to data on hospital, physician and prescription drug benefits that are provided to Medicare beneficiaries. The link provides you with access to both the Grassley press release and the text of the bill, which is not yet on reporting services. Perhaps spurred by the Avandia safety issue, which also brought comment from Senator Grassley, the legislation is a re-introduction of legislation the two proposed in the 109th Congress.
By the way, GlaxoSmithKline has set up a whole Web page about the recent cardiovascular issues associated with Avandia.
Yesterday, Dr. Scott Gottlieb, former Deputy Commissioner at FDA, current fellow at the American Enterprise Institute, and local Washington snappy dresser, had an op-ed in the Wall Street Journal (subscription required). Among other things, he said:
While there are "questions" whether Avandia is associated with certain heart risks — so far unsupported by more rigorous, randomized studies and extensive review by the FDA and other authorities around the world — the NEJM study doesn’t add much new insight into those issues because of its own limitations… The Lancet, NEJM’s British sister-publication, said of the study, "Alarmist headlines and confident declarations help nobody."
Further studies are needed to determine safety of a valuable drug, but now there will be trouble recruiting people for those studies and the market share of the product has plummeted to zero. One has to ask oneself if the hysterical reactions of many, including policy makers – who aren’t medically qualified, aren’t doing more harm than good as diabetes patients are asked to trade a proven benefit out of fear of an unproven risk.