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BioPharm Executive: FDA Gets the Message

10/24/2011 4:21:22 PM

FDA Gets the Message

We're all familiar with Wall Street banks, major pharmaceutical companies, and other corporations that settle various charges and investigations "without admitting any wrongdoing." Now it seems FDA may be doing something similar. After listening to years of accusations that it has become slow, unpredictable, and overly risk averse--charges it has traditionally redirected back at the shortcomings of industry--FDA is offering up a new plan to speed drug approvals.

FDA Commissioner Margaret Hamburg recently introduced a 40-page blueprint for reform, telling the audience at the 3rd Annual Washington Ideas Forum that "the number of new products in the development pipeline is not where we'd like it to be." That's a regret she certainly shares with most folks in industry, but does this proposal move the needle?

While short on details -- FDA has invited industry to pitch in with its own suggestions--the plan covers three broad areas where the agency has heard particularly vociferous complaints: 1) better understanding the needs and communicating more effectively with entrepreneurs and small business people; 2) updating technology to become more efficient; and 3) reorganizing bureaucracy and processes to expedite approvals.

More specifically, FDA proposes establishing a Small Business Liaison program that would hire people with entrepreneurial experience in the biomedical industry. They would in turn help train staffers on improving their communication and working relationships with smaller companies. And they would also offer fellowships to entrepreneurs, to give them first-hand experience on the workings of the agency.

Investing in new technologies is a major theme, particularly as it relates to personalized medicine and "regulatory science," which the agency defines as "the knowledge, tools, standards, and approaches necessary to assess the safety, efficacy, quality, and performance of FDA-regulated products." In a post on the White House Blog, Vicki Seyfert-Margolis of the FDA Commissioner’s Office acknowledges that "as the science that goes into developing these products becomes increasingly sophisticated, the FDA needs to be just as sophisticated in the way we review these products."

Finally, they agency aims to establish an "expedited drug development path" for drugs that target serious, unmet illnesses. How this will happen is still open to discussion, but one idea is to help target clinical trials to the patients most likely to benefit from a drug, thus increasing the efficiency and hopefully reducing the cost of the clinical trials process. And additional reorganization proposals are under consideration. As Seyfert-Margolis broadly notes on the White House blog, "we hear from Americans who want the FDA to work better as one agency, rather than functioning as several semi-autonomous "centers."

So why is all this happening now? In addition to the steady stream of complaints from industry, the Obama Administration has been putting pressure on FDA to step up the pace of innovation. The U.S. remains the clear leader in biomedical innovation, but that leadership has come under increasing threat. Ex-U.S. regulators are regarded as faster and more reliable conduits to approval, and the relative strength of emerging economies has most pharma companies moving both sales staff and R&D to Asia and elsewhere. At a time when jobs and competitiveness are supreme concerns, The White House has a clear interest in keeping the U.S. regulatory system as efficient as possible.

Venture capitalists have been among the most vocal critics of FDA. The day after FDA released its blueprint, a group of VCs went to Capitol Hill to present the findings of a recent survey of 156 venture firms, conducted by an affiliate of the National Venture Capital Association. The survey found that 39% firms have cut back on funding life sciences over the past three years, and they cite dysfunction at FDA as the chief reason.

Some VC groups are pushing to get better funding for FDA, and most are certainly likely to cheer the agency's effort to invest more in new technology. But most are also taking a wait and see attitude right now. There's little in the plan that truly breaks new ground, at least in the general form outlined. But with the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act up for reauthorization in 2012, there will be a chance to reshape how the agency does its work. Bureaucracy is slow to change, but FDA is showing some willingness, and come next year it may get a big push.

-Karl Thiel

Read the BioPharm Executive online newsletter October 26, 2011.

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