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    Tuesday, July 16, 2002

    Slow Learners: As if to prove they've learned nothing from the recent business scandals, Congress is debating whether or not to let medical device companies choose their own inspectors and third-party reviewers, rather than having the FDA police them. The bill is part of an attempt to get the companies to pay the FDA user fees, like drug companies do now. Self-regulation is the suggestion of the companies in response to those user fees. They want something back for their money, and that something is a system in which they only have to answer to themselves. That Congress and the FDA is even considering allowing companies to do this in the wake of the recent Enron and Worldcom scandals is amazing. They apparently haven’t learned anything about the ethics of the business world, or as one consumer advocate put it, “they don’t know a conflict-of-interest when it hits them on the head”:

    Some consumer and patient groups who follow the issue say they are alarmed by the proposals, which they say could weaken safety precautions. According to Diana Zuckerman, president of the National Center for Policy Research for Women & Families, the willingness of the FDA to entertain the proposal shows "they don't know a conflict-of-interest when it hits them on the head."

    "These review and inspection companies know that they have to do a certain kind of job to be selected again," she said. "If they reject an application or find problems during an inspection, it's unlikely they'll get chosen the next time, so they have real incentive to overlook a company's problems."


    We depend on the FDA to protect us from corporate malfeascence in the drug industry. Unfortunately, the FDA is underfunded and not up to the task. Their appropriations committee is the same one that doles out agricultural subsidies, so they get slighted. Too bad our Congressmen can’t break themselves of their pork habits enough to distribute our tax dollars responsibly.
     

    posted by Sydney on 7/16/2002 05:30:00 AM 0 comments

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