Saturday, September 23, 2006

Mr. Fox Has the Keys To the Henhouse

The Food and Drug Administration is just the latest federal agency to come under scrutiny over the way it carries out its mandate. Like most of the others, the FDA received poor grades. From the NY Times

The nation’s system for ensuring the safety of medicines needs major changes, advertising of new drugs should be restricted, and consumers should be wary of drugs that have only recently been approved, according to a long-anticipated study of drug safety.

The report by the Institute of Medicine, part of the National Academy of Sciences, is likely to intensify a debate about the safety of the nation’s drug supply and the adequacy of the government’s oversight.

...The report made these recommendations, most of which would require Congressional authorization:

¶Newly approved drugs should display a black triangle on their labels for two years to warn consumers that their safety is more uncertain than that of older drugs.

¶Drug advertisements should be restricted during this initial period.

¶The F.D.A. should be given the authority to issue fines, injunctions and withdrawals when drug makers fail — as they often do — to complete required safety studies.

¶The F.D.A. should thoroughly review the safety of drugs at least once every five years.

¶The F.D.A. commissioner should be appointed to a six-year term.

¶Drug makers should be required to post publicly the results of nearly all human drug trials.

...Critics of the food and drug agency have long been divided into two warring camps. Some say the agency fails to approve life-saving medicines quickly enough, while others say that it is so intent on rapid approvals that it fails to ensure the safety of the drugs.

The institute’s report champions the latter view by calling for greater caution. It suggests that one of the agency’s biggest problems is a deal struck in 1992 between Congress and the drug industry in which drug makers agreed to pay millions in fees to speed reviews. This deal has increased pressures on drug reviewers to act quickly, and it has limited “the ability of reviewers to examine safety signals as thoroughly as they might like,” the report said.
[Emphasis added]

While the report presents clear and doable recommendations for fixing some of the most glaring deficiencies, the fact that Congress has to authorize the solutions presents the biggest problem. PHARMA is one of the largest and most powerful lobbying groups in Washington. The defective Medicare drug plan is evidence of that.

The pharmaceutical industry is likely to fight at least some of the proposals, said Charlie Cook, a Washington political analyst.

“One should never underestimate the influence of the drug industry,” Mr. Cook said. “But I would think that at least the outlines of many of these recommendations would have a decent chance of getting through Congress.”

A decent chance? Would that be an adequate description for that zone best characterised as "zero to none?" I recommend against holding one's breath for reasonable corrective legislation from Congress in this regard. Until Congress is elected under a system that does not require massive infusions of cash from special interest groups of all stripes, decent reform is just not going to happen.


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