Senators About To Propose Relaxing FDA Conflict of Interest Rules

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A few senators are about to introduce legislation to allow the FDA to relax rules on conflicts of interest for its advisors in determining drug, food and device safety. This is not unlike saying that we should allow Wall Street to determine the regulations put in place for the banking industry. Oh…wait. We did that and we all know how that turned out.

In fairness, there is a reason. These senators are concerned at the slow pace of approvals for new treatments coming out of the FDA. This is a real issue, but since the FDA already has a mechanism in place to allow it to ask for exemptions to the rules in order to get more qualified advisors and is not in fact using that system, it is hard to see that changing the underlying rules will help much either and it could very well hinder if  advisors with conflicts of interest turn out to be unscrupulous.

In the coverage, some of the companies complaining about the FDA refer to inconsistencies as well as delays in the approval process. This is a lot closer to the truth. The FDA has been inconsistent in the past and a fundamental revisiting of its procedures and policies might be more effective than allowing the organization and third parties to play fast and loose with the current system.

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