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FDA Bashing: The Wrong Way to Improve FDA

FDA is imperfect in many ways: it can be hard to predict, maddeningly slow to decide, and inflexible in the face of complex situations. Yet, FDA does remarkably well at carrying out its difficult public health mission. Plus, the agency is constantly striving for improvement.

These points seem lost on agency critics bent on bashing the agency. To believe many of them, FDA is bureaucratically and culturally driven to be ineffective…. and heedless of the impact of its actions on industry innovation and patients in medical need. FDA Matters says: nonsense!

FDA bashing is not a victimless crime. It is a slur on the agency’s good name and many accomplishments. It impedes rational efforts to improve FDA process and performance. It is a barrier to fruitful dialog between FDA and its stakeholders. It drains agency resources and threatens its funding.

FDA bashing is also an incendiary, fostering an environment of “simple, neat and wrong solutions” aimed at fixing the agency.*

FDA bashers make it seem like the world would be a better place if the agency didn’t exist or if its powers were dramatically circumscribed. It’s hard to make FDA a more effective public health and regulatory agency in the midst of such misguided rhetoric. FDA was created–and further empowered over the last 100 years—precisely because regulatory oversight is necessary to assure a safe food supply and safe and effective medical products.

When FDA makes predictable, science-based decisions, patients and consumers benefit from quality products…and industry has the level playing field needed to assure fair competition. This works well most of the time. I’ve heard it said: the world only notices FDA when something goes wrong. That’s largely true.

Believing in FDA and its mission does not require silence or uncritical booster-ism. Let’s all agree that FDA needs to do a lot better before it can be considered the model  for a modern food and drug regulatory agency.

There is a bright dividing line between FDA bashing and working to improve the agency. FDA Matters has praised the Biotechnology Industry Association (BIO) for its positive agenda, even while expressing reservations about BIO’s specific proposals for independent agency status for FDA and a new progressive approval pathway. There have been many positives (and much progress) in the negotiations over medical device user fee reauthorization, even as industry and the agency have bickered privately and in public about the direction of the program.

FDA Matters has been disappointed by many others–industry, patients, Congress, media, and think-tanks–who have emphasized agency bashing at their meetings and in their public communications. Often, the bashing starts with the wrong premise (the agency is largely broken) and concludes with the wrong prescription (break down the agency’s culture and processes and rebuild anew). Not only are these wrong, but they crowd out practical and constructive dialog about agency improvement.

FDA has (in my view) gone out of its way to welcome comments and respond thoughtfully. There is so much more to do….but the agency is not hiding from criticism or arguing reforms are unnecessary.

Other stakeholders seem to be responding in kind. I am involved with at least two efforts to build FDA reform agendas and would welcome the opportunity to participate in others.

FDA Matters believes the right way to improve FDA is through constructive recommendations and thorough discussion. FDA and our nation deserve better than vitriol about how FDA is destroying jobs and is “the enemy.”

Steven

* After H.L. Mencken’s admonition that “for every complex problem, there is a solution that is simple, neat and wrong.”

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