Yesterday, I received separate posts from three organizations that are anti-industry, one of which dislikes FDA and one of which hates FDA. They are not alone in these feelings. There are many groups and individuals who believe that industry and physician professional societies run FDA. I don’t accept their premise or the “facts” from which they launch attacks.
On the same day, I got an update from Americans for Medical Progress (AMP), an organization that educates media and the public about the importance of animal testing in advancing human health. FDA could not do its job without animal studies, both their own and those submitted by sponsors. AMP is among the “good guys” and can always use more support for their work, www.amprogress.org.
I would like to say that all the advocates, such as AMP, are realists and advance the common good by advocating for NIH and FDA….and that all the extreme critics and haters are irrational and inflammatory. It isn’t that simple.
The FDA I know is a regulatory agency staffed by smart people trying to do their best. Given its mission, FDA is inherently imperfect and always vulnerable to criticism. The agency has been chronically understaffed and hasn’t been able to give every decision the attention it might deserve.
I am on my tenth FDA commissioner. Bad decisions were made during each of their tenures and they all experienced bad days when nothing seemed to work the way it should. Meantime, hundreds of drugs and devices have been approved without subsequent mishap. Our food supply is vulnerable because of globalization, yet it is the safest in the world.
Those who dislike or hate FDA focus almost exclusively on those bad decisions and on the agency’s most difficult days. In their minds, that is the FDA. They don’t see the rest of the days where things went well: public health improved, patients received new FDA-approved therapies and more than 300 million Americans ate food without an outbreak of foodborne disease.
Because they ignore the good days and focus only on the bad, the haters feel justified in concluding that the agency is corrupt and deserving of vilification. I disagree vehemently with this premise.
I see some of the same problems they do, but recognize the problems are only a small part of FDA’s mission and accomplishments. Given this wider perspective, it is misguided to impugn FDA and its staff. Bad days occur, but not because of impure motives or because agency officials blindly listened to the industry’s views.
Those who dislike and even hate FDA serve a purpose. Scrutiny makes everyone think and work a little harder to make good decisions. Companies with safe manufacturing plants can still get in trouble with FDA if they haven’t documented their safety-related activities. So, too, FDA needs to be able to show it has listened carefully and decided wisely. It can’t just assert its decisions are good ones. Better documented and more predictable decisions are needed.
All of this can be taken too far….so that over-cautious decisions become a source of delay or failure in meeting the needs of patient and consumers. The haters would certainly like it that way. The extreme critics serve some useful purposes in a narrow sense, but they are wrong about the big picture of FDA’s mission, intent and accomplishments. It is critical that we act civilly in the face of this hatred. That said, we must act to counter their arguments and make sure that the extreme version of FDA-bashing has no reputable standing in Congressional, media and public discourse.
Steven
More predictable decisionmaking at FDA was discussed in an earlier column.
In Praise of Predictability September 3rd, 2009
FDA has always found it challenging to make its actions predictable. This problem will worsen for a number of months while Dr. Hamburg redefines the agency’s mission, policies, actions and working assumptions. Once this has been accomplished, the agency will become dramatically more predictable to stakeholders, including Congress. Read the rest of this entry »
I received a few inquiries from readers asking who I was talking about that dislikes/hates FDA. While I won’t name names in this column, I realized there was more I could have said.
Of those who dislike or hate FDA, you can count the animal rights groups, the antipsychiatry groups, and one or two (maybe more) ex-FDA’ers who write screeds from time to time. Also, there are some anti-industry types who rope FDA in. Their reasoning is that industry influence could be defeated if only FDA was not corrupt.
Groups like Public Citizen’s were NOT who I meant. Dissent, calls for reform, and even a little anger are mainstream by comparison and don’t qualify as signs of dislike or hatred toward the agency.
In any case, the point of the column was to explain why these folks are so vehement and can’t really be reasoned with. Hopefully, I shed some light on how they think. Steven