Avoiding the Gray Twilight

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  • 04/17/2013

Far better it is to dare mighty things, to win glorious triumphs even though checkered by failure, than to rank with those poor spirits who neither enjoy nor suffer much because they live in the gray twilight that knows neither victory nor defeat. – Theodore Roosevelt

Gray twilight be damned!

According to Rick Pazdur, if all drugs cleared for accelerated approval succeed in their confirmatory studies, then the FDA is being overly conservative in its use of the expedited approval pathway.

At the American Association for Cancer Research annual meeting in Washington, D.C., the Office of Hematology and Oncology Products Director said that if none of the drugs receiving accelerated approval is ever withdrawn, then the agency is taking an overly conservative approach in its approval of products under the pathway. “If you are demonstrating the correct degree of regulatory flexibility, there are going to be successes and there are going to be failures … If there are no failures, you … are being over-regulatory and over-conservative.”

Dr. Pazdur made his remarks while moderating a panel discussion among former chairpersons of the agency’s Oncologic Drugs Advisory Committee. A portion of the two-hour discussion focused on the FDA’s actions to withdraw accelerated approval of Avastin’s metastatic breast cancer claim -- and the lasting impact of that regulatory action on the accelerated approval pathway.

Pazdur: “If you take a look at the resources that went into that public hearing for Avastin, it would be impossible for the FDA to do that on a repeated basis,” he said. “I would just guesstimate that millions of dollars in resources, FTEs etc., lawyers, trying to do that hearing in a coherent fashion were spent, and probably even a greater amount by the company.”

Attention Policy Makers: Regulatory creativity, and innovation costs money.

 Pazdur: “I want to put forth a general principle here. If … the agency is using accelerated approval appropriately, there will be drugs that will have to come off the market,” he said. Accelerated approval may be granted based on a surrogate endpoint that is reasonably likely to predict clinical benefit, he noted. “That doesn’t mean that it’s a definitive demonstration.”

“You have to have a balance of drugs that make it and drugs that don’t if you are really going to be demonstrating the correct degree of regulatory flexibility. If all the drugs make it basically, why call it accelerated approval?



Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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