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.”
Hi Steve,
I agree that mindless bashing of the agency is useless or worse, but FDA has helped maintain the vitriol by characterizing EU patients as guinea pigs (in the context of device approvals) and by blaming all the delays in the 510(k) program on industry. In both instances, that was Jeff Shuren, MD, director of the Center for Devices and Radiological Health.
I would be interested in seeing some examples of what you see as excessive rhetoric, but I think you might include Congress in all this. The idea that Capitol Hill is not part of the problem simply doesn’t pass the sniff test if you ask me. I think it’s also a bit short of an exhaustive review of the issues to leave out the mainstream media, which are not particularly adroit at telling the full story. [Editor’s note: I agree with Mark on these points and have amended the article to list Congress and the media as sources of FDA bashing]
And finally, one might also factor in the letters from FDA staffers to the Obama administration and members of Congress in 2008 and 2009 complaining about being overruled on device applications. FDA is indeed part of the problem, as is Capitol Hill. To omit all this almost seems to suggest that government itself in its many forms is not a major contributor to these problems. In fact, government is manifestly part of the problem. That should be part of the discussion.
I think we should insist the industry itself (primarilty big Pharma CEOs and their exec teams) take the major portion of responsibility for the issues we now see. Let us not forget that the proliferation of outsourcing, virtualization, in/out licencing, multiple service providers etc etc has resulted in an industry so fragmented that it is almost impossible to hold anyone accountable – so the FDA get to be piggy-in-the-middle. We shouldn’t blame the police for crime and neither should we hold FDA to account for dysfunction in the industry – all FDA can do is pull the right levers and current indications seem to be that they are doing that in many cases.
Fm: Abigail Alliance for Better Access to Developmental Drugs http://www.abigail-alliance.org
You obviously have not had to deal with the FDA blocking help for your child fighting for her life, as was the case ten years ago with my twenty-one year old daughter Abigail, or your wife, as was the case with our Abigail Alliance cofounder Steve Walker. You obviously do not know of the fifty or more meetings the Abigail Alliance for Better Access to Developmental Drugs has had with high level FDA people over the past ten years, including all the commissioners. It is not bashing! It is genuine frustration with the FDA preventing tens of thousands of people over the past ten years from being able to live, and hundreds of thousands of people having the right to fight for their lives. Do you remember how the AIDS folks felt some years ago?
Frank Burroughs, President, Abigail Alliance for Better Access to Developmental Drugs