Drug approvals fall. Who’s to blame?

The FDA approved 38 drugs through July this year, down 31 percent from 55 approvals for the same period last year.

Who’s to blame? According to Friedman, Billings, Ramsey, the FDA. Why? Vioxx.

For details on extra scrutiny being applied by the FDA, see this CNNMoney summary.

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  1. Neil S
      September 6, 2007

    I found the following quote from the CNNMoney article to be strangely disconcerting:

    “Hawthorne said that the regulatory policy ‘cycle always turns,’ and that the FDA will eventually lower the bar again, as patient advocacy groups complain that the sluggish review process keeps people from getting the drugs they need.”

    Do we really want the FDA to “lower the bar”? Patient safety should be at the top of the FDA’s priority list, not at the number of drugs that make it to the market. I guess this raises the question, is the bar too high right now or is at an appropriate level?

  2. BiotechBlog
      September 7, 2007

    Drug safety is a tricky balance. It is impossible to ensure that all drugs are absolutely safe. The best one can hope to accomplish is to develop a system that is as effective as possible at measuring the safety of drugs.

    In focusing on safety, however, you’ve got to balance loss of access to drugs. Improving safety often means increased costs and longer development times. An extreme focus on safety would necessarily mean that some drugs would not be developed due to high development costs, and that some other drugs (maybe even life-saving drugs) would be needlessly delayed by excessive safety controls. Overly-emphasizing access to drugs isn’t a good solution either, because it would yield too many unsafe drugs. So what’s worse — succumbing to a disease because drugs aren’t yet available or succumbing to unsafe drugs?

    So the bar for safety is continually moving as regulatory sentiments favor access or safety.