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Thursday, June 07, 2007

Avandia Controversy Proves the Need for Better Regulatory Authority

The Washington Post recaps yesterday's House Oversight and Government Reform Committee hearing on the safety of the diabetes drug Avandia manufactured by GlaxoSmithKline. According to the article, a New England Journal of Medicine analysis "concluded that Avandia increases the risk of heart attack by 43 percent." However, FDA is "still analyzing conflicting data" about the drug's effects.

There may not be consensus on the exact side effects of Avandia, but one thing is for sure: Avandia has been on the market for years and no one — not FDA, GlaxoSmithKline, Congress, or the public — is confident of its safety.

Such obvious lapses beg a solution. The FDA reform bill passed by the Senate last month would expand FDA's ability to force drug makers to conduct prompt post-market safety studies. Some aspects of the bill (expanding the agency's user-fee program) are problematic, but this provision is a must pass.

Similar drug safety problems are bound to occur in the future. But there is no excuse for being unsure of a drug's side effects for so long. Drug makers and the FDA should stop trying to cover their mistakes. The American people are smarter than they think. Knowledge breeds confidence. FDA should be in the business of providing the public with knowledge.