Congress should not reauthorize FDA Prescription Drug User Fee Law, Opinion Piece states

Feb 26, 2007--"It's time to take the FDA back" from pharmaceutical companies, Marcia Angell, a senior lecturer at Harvard Medical School, writes in a Boston Globe opinion piece.

According to Angell, "Congress put the fox in the chicken coop" in 1992 with the passage of the Prescription Drug User Fee Act, under which pharmaceutical companies agreed to pay user fees for reviews of new medications.

Most of the user fees, which last year totaled about $300 million, are "earmarked to speed up the approval process," and the fees in effect place FDA "on the payroll of the industry it regulates," Angell writes.

She writes that the user fees have "drastically changed" FDA operations, with a "disproportionate emphasis on approving brand-name drugs in a hurry" and less focus on efforts to monitor prescription drug safety and manufacturing standards.

"More tellingly, the office that approves generic drugs is so small that approval time for generics is twice as long as for brand-name drugs" -- a delay that "is worth billions of dollars to the drug companies whose high prices depend on not having generic competition," she adds.

FDA also approves brand-name medications on the "basis of less evidence than in the past," with approval often "contingent on companies conducting further safety studies after the drugs are on the market," but the "companies usually don't honor that commitment," according to Angell. In addition, she writes that the "agency's coziness with industry is underscored by the composition of its 18 advisory committees," whose members often work as consultants for pharmaceutical companies.

She recommends that Congress not reauthorize the user fee law and "substitute its own support," adding that "Congress can easily afford to buy this vital agency back for the public" (Angell, Boston Globe, 2/26).