Categorized | Opinion Editorial, QbD News

von Eschenbach: Why FDA Lags Behind

    von Eschenbach: Why FDA Lags Behind

    Former FDA Commissioner Andrew von Eschenbach took to the Wall Street Journal this week to weigh in on the problems of his former employer, and to encourage Congress to better support the Agency. FDA doesn’t have the “scientific tools and resources” it needs, von Eschenbach writes. (Registration required for full article.)  “Congress has starved the agency of critical funding, limiting its scientists’ ability to keep up with peers in private industry and academia. The result is an agency in which science-based regulation often lags far behind scientific discovery.”

    As result, he says, FDA is slow to assess and approve new treatments, leading to litigation from innovating companies and disillusionment among patients.

    “FDA scientists typically have little contact with the scientists who know the most about these innovative technologies,” he continues. “This is not because they don’t want to. But consumer groups distrustful of industry have led Congress to erect ever greater barriers between regulators and those they regulate. The FDA can convene advisory committees of outside experts, but these experts weigh in only at the end of the regulatory process. Worse, congressionally mandated conflict-of-interest rules keep many of the most knowledgeable academic and industry scientists off advisory committees out of fear that industry ties might bias their judgment.”

    He concludes: If it expects FDA to truly lead innovation, Congress must give the Agency “the resources to be the world’s foremost science-based regulatory agency,” provide support to better train its staff, and allow freedom to collaborate with scientists everywhere.

    Here again is the link to the article.

    –Paul Thomas

    Related posts:

    1. Moheb Nasr Exits FDA for GSK
      One of the architects of QbD has decided to leave the Agency after 22 years....
    2. Surveys Examine Pharma’s, and the Public’s, Views of FDA
      In two new surveys, Price Waterhouse Cooper analysts examine industry's and the public's views of FDA. Although they note improvement...
    3. Can Regulatory Harmonization Be More Effective, and Equitable?
      A new not-for-profit will champion global regulatory “capacity building,” and aims to correct what it views as failures by the...
    4. Draft Guidance: Qualifying Drug Development Tools
      The FDA issues draft guidance for biomarkers and patient reported outcome tools, and hopefully much more....
    5. FDA Maps Out Its Own Scientific Future
      Hot off the press: a report on how FDA plans to upgrade its own regulatory science to facilitate advances in...

    One Response to “von Eschenbach: Why FDA Lags Behind”

    1. zasmine says:

      It is a very state indeed when the regulator doesn’t know what they are regulating.


    Leave a Reply

    You must be logged in to post a comment.