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WSJ: The FDA Should Approve Drugs Based on Safety and Leave Efficacy Testing for Post-Market Studies

From EyewireToday.com — 2/14/2012
FDA Approval/Clearance

In an article that appeared in Tuesday's Wall Street Journal, columnist Andrew Von Eschenbach challenged the regulatory procedure of the FDA, calling it slow, outdated, and unable to keep up with the innovation of the companies it regulates.

The column, titled “Medical Innovation: How the U.S. Can Retain Its Lead,” Mr. Eschenbach says there is a growing recognition—at the agency, in the industry and among patients' groups—that the FDA is at serious risk of falling behind its core responsibility of evaluating new medical products in a timely and predictable manner.

“Other countries such as Israel, Singapore and China are already preparing to leapfrog the U.S. for leadership of the global life-sciences industry. And investors and companies are shifting jobs and research abroad as part of an offshore strategy to cut costs and reach the market faster.”

According to the article, unanticipated side effects of high-profile drugs like Vioxx have pushed the agency to require more data and larger clinical trials from companies to search for rare adverse events. It cites the Tufts Center for the Study of Drug Development, which reported that clinical trials from 2003-2006 were nearly 70% longer than those from 1999-2002.

“Longer and more complicated trials have led to skyrocketing drug-development costs. High costs discourage investment in much-needed new therapies for conditions like obesity, diabetes and heart disease.”

Mr. Eschenbach calls on Congress and the Obama administration to make reviewing and modernizing the FDA a top priority. Congress is currently considering legislation to reauthorize the agency to collect the fees companies pay for the review of every new drug and medical device application submitted to the FDA. This presents a rare opportunity to examine the FDA's overall needs and performance, he says.

“Congress should not only set the fees and add resources for the agency but also modernize it from the bottom up. This includes a comprehensive external review of the agency's regulatory processes. It also means creating FDA pilot programs to bring promising therapies to patients more quickly by allowing them to be approved based on safety, with efficacy to be proven in later trials.”

One example he uses is that of regenerative medicine and the impact on age-related macular degeneration.

“If a company can grow cells that repair the retina in a lab, patients who've been blinded by macular degeneration shouldn't have to wait years while the FDA asks the company to complete laborious clinical trials proving efficacy. Instead, after proof of concept and safety testing, 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.”

To read the article in its entirety, visit http://online.wsj.com/article/SB10001424052970203646004577215403399350874.html?mod=WSJ_Opinion_LEFTTopOpinion

Dr. von Eschenbach is the chairman of the Manhattan Institute's Project FDA. He is former director of the National Cancer Institute and Commissioner of the U.S. Food and Drug Administration (2005-2009).

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