Tom Coburn and Project FDA

As the newly former Senator Coburn takes a look back at his former colleagues in Congress, and a look ahead to the work he will be doing at the Manhattan Institute for Policy Research, the former physician is lamenting the FDA’s processes. “There are drugs all over the world that can’t be used here because we have a bureaucracy that doesn’t bend with the times”, he told the Washington Examiner in a recent interview. But the FDA takes flack from those who want more regulation and, on the other side, from those who want a streamlined approval process rather than the mulit-year billion dollar slow moving conveyor belt that exists today for any new drug to be FDA approved. It’s a tough place to be in, and they seem to do a poor job of it.

A Vanity Fair article a few years ago revealed the use of clinical trials in what are called 'rescue countries' like Morocco or Hungary or Tunisia, that come to the rescue of a drug like Ketek that was approved after people were arrested in America for falsifying clinical trial data. The trials moved overseas, and the drug was approved to disastrous results as patients began to have adverse reactions, some even dying. At the hearings held in Congress in the wake of the Ketek scandal, former FDA officials, insiders with lots of experience, criticized the agency for breaking its own rules. So the question becomes: how do pharmaceutical companies innovate without harming people? And what role is the right one for the FDA in that process?

Former Senator Coburn has a set of clear ideas on this, and needs to be listened to. Whether his work at Project FDA will resonate in the halls of Congress, and actually bring about a change of culture in the FDA itself, remains to be seen. There is a powerful monopoly in place, shielded by the regulations that the FDA, at least in theory, enforces. Ron Paul's attempt at allowing competition in his Health Freedom Protection Act, back ten years ago, may not have pleased the drug industry. But it was an attempt to allow supplements to advertise claims backed up by clinical trials. If it works, according to a well designed clinical study, a supplement should be allowed to claim those results. They are not, because they are classified as foods. Another FDA regulation. Somewhere between claiming that belladonna can replace all anesthetics, and suppressing all clinical trials that do not fit the drug manufacturing lobby needs, there should be a pragmatic approval process. One that uses science, but allows innovation and competition. Let's hope the former senator is listened to in the months and years ahead.

Posted by Keeley at April 20, 2015 8:05 PM
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