The Chilling Effect of Congressional Micromanagement on Drug Approvals

Ph03349iThere is an excellent opinion piece in the Wall Street Journal today called Grassley’s War on Cancer Patients – which though the content is right on, the headline is a bit off. 

The point of the article is that Congress in general, and Senator Grassley in particular, are overzealously reviewing FDA decisions to the point that it will have a chilling effect on the FDA’s ability to approve new drugs in the future.  It was written by Dr. Mark Thornton, former medical officer in the division of Oncologic Drugs at FDA.  His article focuses on the fact that in February Senator Grassley asked the GAO to review the FDAs decisions regarding the use of surrogate endpoints in the approval of three drugs, as reported here at Eye on FDA on March 5.   In fairness the request to examine the use of surrogate endpoints was broader than cancer, involving other therapeutic categories.  Senator Grassley’s war is less on cancer patients than on surrogate endpoints.

Nevertheless, the article is testament to the fact that zeal exists in Congress right now for second-guessing FDA decisions based on political expediency, rather than a fundamental medical and scientific understanding of surrogate endpoints.  In fact, members of Congress (MOCs) have, in general, looked for mistakes made by the FDA ever since the problems surfaced with COX-2s.  And since that time, the FDA has provided many, many reasons for MOCs to question the agency with respect to actions and inactions of the agency.

Still, the extent to which Congress is willing to micromanage individual drug approval decisions may reach a ludicrous level.  After all, if Congress is so good at scrutinizing the efficacy of government, our foreign relations would be a LOT better than they are right now.  I don’t think public confidence in the safety of drugs is going to be shored up by Congressional investigation into FDA decisions given the fact that public confidence in Congress itself is not exactly riding high.  Therefore, one has to question whether or not the risk of Congressional micromanagement of FDA decisions is worth the benefit, if there is one.

But also, with respect to surrogate endpoints, the fact is that much of the future development of drugs and pharmacogenomics and personalized medicine are going to have to rely on personalized medicine.  And, to Dr. Thornton’s point, there are a number of very promising oncologic drug candidates in the pipeline.   

The fact is, as Dr. Thornton pointed out, that surrogate endpoint approvals have brought us some major medical breakthrough’s and were created largely in response to the overwhelming desire by the HIV community to gain faster access to promising therapies.  That was in the 1990s.  Today in the 00’s, the emphasis is less on access than it is on safety.  For those patients waiting for the next breakthrough, Congressional micromanagement to second-guess FDA, particularly on surrogate endpoints is not only political folly, it may be medical folly as well.   

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1 Response to The Chilling Effect of Congressional Micromanagement on Drug Approvals

  1. Kerry Donahue says:

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