Regulatory Focus™ > News Articles > Former FDA Commissioner: Approve Drugs Based on Safety, Prove Efficacy Later

Former FDA Commissioner: Approve Drugs Based on Safety, Prove Efficacy Later

Posted 14 February 2012 | By Alexander Gaffney, RAC 

Former US Food and Drug Administration (FDA) Commissioner Andrew Von Eschenbach has an op-ed in the 14 February edition of the Wall Street Journal in which he calls for some drugs to be approved based on only premarket indications of safety, with testing on efficacy and effectiveness to be left for postmarket studies.

"[T]here is a growing recognition-at the agency, in the industry and among patients' groups-that it is at serious risk of falling behind its core responsibility of evaluating new medical products in a timely and predictable manner," writes Eschenbach. "Without an FDA that is as innovative and sophisticated as the companies it regulates, patient health and US-based innovation will suffer."

Eschenbach notes that "unanticipated side effects of high-profile drugs like Vioxx" have caused FDA to demand larger and larger clinical trials in an attempt to root out adverse events before the products reach consumers. According to a Tufts Center for the Study of Drug Development study cited by Eschenbach, "clinical trials from 2003-2006 were nearly 70% longer than those from 1999-2002."

The solution, according to Eschenbach, who led the agency from 2005 to 2009, is to modernize the agency by launching "FDA pilot programs to bring promising therapies to patients more quickly to be approved based on safety, with efficacy to be proven in later trials."

Instead of premarketing clinical trials, "the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies."

Industry observer Merrill Goozner, however, noted that industry already fails to complete many postmarketing trials mandated by FDA, and that the idea is likely a non-starter.

Writing on the website PharmaLot, Ed Silverman said that "the pharmaceutical industry would benefit, since fewer trials would be required prior to approval, which would lower development costs."

But Silverman also mirrored Goozner's point by saying that "the industry has a poor track record of initiating post-marketing studies promptly, or even at all," and that it is unclear "how long such a scenario would exist."

WSJ - Medical Innovation: How the U.S. Can Retain Its Lead


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