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    Faster Drug Approvals Linked to Safety Issues

    By Larry Hand
    Medscape Medical News

    Aug. 14, 2014 -- In the years since the FDA sped up its drug-approval process, the rate of black box warnings on prescription drugs, as well drug withdrawals, has increased, according to an article in the August issue of Health Affairs. The agency imposes black box warnings to highlight side effects that could be disabling or life-threatening.

    Cassie Frank, MD, an instructor of medicine at Cambridge Health Alliance in Massachusetts, and colleagues looked at the history of 748 new drugs approved by the FDA between 1975 and 2009.

    They compared the records of those approved before and after the 1992 passage of the Prescription Drug User Fee Act (PDUFA). That law allowed the FDA to collect fees from pharmaceutical companies to pay for resources needed to speed up the drug-approval process. PDUFA has been renewed four times since 1992.

    Of the new drugs approved for the entire period, 114 (15.2%) had received one or more black box warnings, and 32 (4.3%) were withdrawn from the market for safety reasons.

    In total, label changes for all black box warnings plus withdrawals came to 208 (27.8%). Half of the warnings were issued within 12 years of approval, and half of the withdrawals happened within 5 years of approval.

    The researchers found that drugs approved after enactment of PDUFA were more likely to be withdrawn or to receive a black box warning. The rate of warning or withdrawal climbed from 21.2 per 100 drugs before PDUFA to 26.7 per 100 afterward.

    "New drugs have a one-in-three chance of acquiring a new black-box warning or being withdrawn for safety reasons within twenty-five years of approval," the researchers conclude.

    "We believe that the ultimate solution is stronger U.S. drug approval standards. In the interim, with the rare exception of truly breakthrough therapies, doctors should preferentially prescribe drugs that have been on the market longer and hence have a more established track record of safety."

    FDA, Industry Counter Findings

    The FDA issued a two-paragraph statement in response to the article: "PDUFA has enhanced pre-market review and created a modern post-market drug safety system that follows products across their full life cycle. 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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