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

  1. Kerry Donahue says:

    FDA SAYS, “WAIT” TO DYING MEN
    COAST-TO-COAST PROSTATE CANCER DEMONSTRATIONS ON MAY 30th IN PROTEST OF FDA FAILURE TO APPROVE SAFE, EFFECTIVE IMMUNOTHERAPY
    On May 30, 2008, CareToLive will take to the streets with coast-to-coast protests in Chicago, New York, Philadelphia, Cleveland, Madison, Atlanta, Seattle, Dearborn, and Tampa. Joining us will be the Cancer Cure Coalition, the Abigail Alliance, and A Right To Live. We are asking all patient advocates to come out and attend a protest.
    1 in 6 men get prostate cancer. 75 American men die from it every day. The FDA has not approved a treatment for stage IV prostate cancer in over 43 years.
    CareToLive, a not for profit corporation, seeks transparency and accountability from the FDA, as to why they disregarded the advice of their hand selected Congressionally mandated Advisory Panel of experts, who voted Provenge overwhelmingly safe and effective. Without cause or explanation, in an unprecedented action, the FDA denied licensure. We are seeking immediate access to Provenge for all men with end stage prostate cancer.
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    The dysfunctional FDA’s reason for delay has never been explained, as it was not science based, since survival and safety have been clearly demonstrated.
    CareToLive filed a Citizens Petition for the FDA to reconsider the wrongful denial, (the only recourse the FDA allows), on July 26, 2007. The FDA has failed to follow Federal regulation and to this day they have not properly responded to our Petition, which seeks immediate access to Provenge for these desperate men. The FDA also refuses to respond to the CareToLive Freedom of Information Act request, which they know would prove that a few FDA insiders, who cared more about serving their own interests, rather than the best interest of the patients, purposely sabotaged Provenge.
    “In memory of our members who have recently passed away, never having been given the chance Provenge recipient Eduardo Garcia had, we will continue to fight on, every day, in every way we can. Please come out and join us,” CareToLive spokesperson, Mike Kearney, said.
    LOCATIONS:
    Seattle, Washington — 1 PM PDT
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    Coordinator – Jason Burdine jnaburdine@comcast.net
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    Chicago, Illinois — 3 PM CDT
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    Coordinator – Mike Kearney – publicrelations@caretolive.com
    Co-coordinator- Rory Kearney – rk@caretolive.com
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    Memorial Sloan-Kettering Cancer Center — 1275 York Avenue
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    For more information go to http://www.CareToLive.com