Given the cynical political manipulation of the FDA’s decisions over the past few years, it is hard to greet this as a victory:
By a vote of 93 to 1, the Senate passed a bill this afternoon that gives the Food and Drug Administration sweeping new power to police drug safety, order changes in drug labels, and restrict the use and distribution of medicines found to pose serious risks to consumers.
The bill calls for a fundamental change in the philosophy and operations of the F.D.A., requiring the agency to focus on the entire life cycle of a drug — not just the years prior to its approval, but also the experience of patients who later take it.
Senators said the bill was a response to a widespread loss of confidence in the ability of the F.D.A. to protect consumers against the dangers of drugs like Vioxx, a popular painkiller withdrawn from the market in 2004. The bill would carry out many recommendations from the National Academy of Sciences and appears broadly acceptable to the House. The Bush administration has not actively opposed the measure and many drug manufacturers support it.
The bill is widely seen as “must pass” legislation because it renews authority for the government to collect fees from drug companies to speed the review of their products. Without action by Congress, the authority would expire Sept. 30.
The cardinal rule for me is that anytime a bill receives complete bipartisan support, it is universally a bad thing. The possibility for further politicization and mayhem appears to be overwhelming.