September 21, 2007
Increased FDA Scrutiny of Legacy Drugs
Editorial in the Wall Street Journal -- The FDA vs. Small Pharma. Here's an excerpt:
Western Europeans began using quinine as a medicine in the 17th century. Then again, they didn't have to comply with the modern FDA.
In a little-noticed program announced last June, the Food and Drug Administration is cracking down on remedies like quinine. These belong to a class known colloquially as legacy drugs: That is, they are generally recognized as safe and effective, and have been prescribed by physicians for decades, in some cases before the modern FDA regime was created in 1962. But since they lack a formal FDA stamp of approval, they're being yanked from the market.
In a more rational political world, legacy drugs might be "grandfathered in," since the risks they pose are so few. The FDA, however, remains under intense scrutiny for handling of pharmaceutical safety in the aftermath of the Vioxx furor. So the agency is pulling out all the bureaucratic stops to mollify its Capitol Hill critics like Pete Stark and Chuck Grassley.
... [T]he FDA is requiring them to be put through the same regulatory wringer. Some must complete a New Drug Application, which requires clinical trials and can cost between $5 million and $10 million per legacy drug. The alternative, an Abbreviated New Drug Application, still costs over $1 million. That's a lot of money to reinvent the wheel.
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