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Warnings and Withdrawals

Drugs approved since legislation to speed up the approval process at the US Food and Drug Administration are more likely to have received black box warnings or been withdrawn from the market, according to a new analysis appearing in Health Affairs.

The Prescription Drug User Fee Act was implemented in the early 1990s — and renewed several times since then — to allow FDA to collect fees from drug companies to speed the approval process. Since then, the researchers note, the time to approval for a drug has decreased from 33.6 months to 16.1 months.

Boston University's Karen Lasser and her colleagues examined drugs approved between 1975 and 2009. In that timeframe, FDA approved nearly 750 new molecular entities, of which 114, or 15.2 percent, received one or more black box warning and of which 32, or 4.3 percent, were taken off the market for safety reasons. The researchers also calculated that there were 34.0 withdrawals or new warnings per 100 drugs in 25 years of follow-up.

Half of the warnings for a drug occurred within its 12 five years on the market, and half of the withdrawals occurred within five years of being on the market, they note.

Drugs approved after PDUFA were more likely to receive a black box warning or be withdrawn from the market — 26.7 events per 100 drugs versus 21.2 evens per 100 drugs — at 16 years of follow-up, according to the researchers' calculations.

"The FDA is under constant pressure to rush new drugs through the pipeline to approval," says first author Cassie Frank from Cambridge Health Alliance and Harvard Medical School in a statement. "In its hurry, the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through."

FDA tells Pharmalot at the Wall Street Journal that the act has helped the agency modernize. "PDUFA has enhanced pre-market review and created a modern post-market drug safety system that follows products across their full life cycle," it says. "Specifically, PDUFA provides FDA revenue to hire additional reviewers and support staff and upgrade its information technology systems to maximize the efficiency of the application review process for new drugs and biological products without compromising FDA's high standards for approval."

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