Sunshine on FDA Decisions

J0182630 The New York Times reports that the Obama Administration will announce today that a panel will be formed to make recommendations on how information about FDA decisions can be made more transparent related to approvals for drugs and devices.  That effort should go further and apply to all policy decisions made at the agency.

For example, the 14 letters from DDMAC.  Following the decision, I requested a follow-up podcast with FDA to talk about the motivation and reasoning (or lack thereof) behind the decision.  The FDA refused.  The only thing worse than a bad decision is the hubris associated with the perspective that the agency does not have to explain itself.  It does.  It should. 

The aim of the panel is to ensure that when the FDA has information about some concerns of drugs, that the information be revealed more completely than under the current system.  Specific drugs are named in the article as examples where the FDA knew of risks, did not reveal them, and then became problematic later.  Up until now, the FDA has retained information that is perceived as proprietary in nature – as trade secrets.  The balancing act may be difficult to strike, since there are indeed proprietary issues associated with the drug approval process, but clearly the FDA has dropped the ball in developing and executing a sound policy in this regard.  A measure to correct that could go a long way to re-establish lost credibility for the agency and for industry. 

It is in the interests of all that information be revealed and that context be provided, whether it is about a drug, a device or a policy decision by the FDA.  By the same token, scaring the hell out of the public about new drugs could also retard progress and raise undue concerns.  The approach that this task force takes needs itself to be carefully reasoned, and carried out in the same sunshine as the drug approval process. 

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1 Response to Sunshine on FDA Decisions

  1. Brian says:

    The FDA’s primary responsibility is approving high quality compounds that are effective for their labeled indication(s) and that the company provide directions of use that are complete and honest. Increasingly I hear from both the scientific and lay community the need for the FDA to increase it’s emphasis on a compound’s benefit to risk ratio, which is a very difficult balance. On the one hand as a society we desire innovative treatments to diseases that plague our loved ones and us. However, innovative compounds inherently come with risk. On the other side of the equation we are demanding greater safety profiles of compounds that enter the market. Again, a tough balance that will eventually be assisted with the emerging landscape of targeted treatments for specific genotypes. However, until then more transparency that does not hinder the drug approval process is welcomed.

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