Grassley Inquiry Into Fast-Tracking Of Drug Applications Could Hurt Cancer Drug Development, Patients, Op-Ed States

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 30 May 2008 - 12:00 PDT

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Sen. Chuck Grassley's (R-Iowa) request that the Government Accountability Office investigate whether FDA acted appropriately in granting "accelerated approval" to a cancer drug "will have a catastrophic effect on America's ability to develop new drugs," Mark Thornton, a former medical officer in FDA's Office of Oncology Drug Products and president of the Sarcoma Foundation of America, writes in a Wall Street Journal opinion piece. The drug, Avastin, was granted accelerated approval for treating women with metastatic breast cancer after showing early evidence of an effect on the "surrogate endpoint" known as "progression-free survival," according to Thornton.

Grassley "implied in his GAO request that something sinister occurred during the FDA's premarket deliberations and that surrogate endpoints were the new bogeyman," Thornton writes, adding, "Nothing could be further from the truth." He states that evaluating a cancer drug's effect on surrogate endpoints, as opposed to impact on overall survival, to potentially allow "expedited" approval of drugs has "won near-universal acceptance within the cancer community."

Grassley "is demanding a full-scale review of each and every product ever approved and is asking for a re-judgment by GAO 'to ensure that drugs approved on surrogate endpoints are both safe and effective,'" according to Thornton. However, the senator's "bully tactics" could cause cancer drug development to "slow to an absolute crawl" because the "extremely cautious and protective" FDA "will respond to such intimidation by being even more protective," Thornton writes.

He adds, "U.S. cancer drug development stands on a precipice overlooking a new dark age in which each new product's development is longer and costlier than the last," and drug makers may "decide it is not financially viable to even bother developing new drugs." Thornton writes, "Mr. Grassley's legacy could be thousands of additional cancer deaths" (Thornton, Wall Street Journal, 5/29).

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