Press Release

Health Subcommittee Examines FDA Regulatory Process


WASHINGTON, DC – The House Energy and Commerce Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), today discussed reauthorization of the Prescription Drug User Fee Act (PDUFA), which expires on September 30, 2012. Working properly, this program helps bring life-saving drugs to patients and promotes significant job creation while keeping America the hub of medical innovation. The subcommittee also examined how to improve the Food and Drug Administration’s regulatory process, as the FDA has become less transparent and increased the time it takes for products to reach those who need them. Members pressed FDA Director Janet Woodcock on how the FDA’s regulations create uncertainty that stifles American innovation, costs American jobs and hurts patients.

“Americans are the most innovative people on earth,” said Pitts. “Given certainty, predictability and transparency in the approval process, venture capitalists will continue to fund new research, and companies will continue to develop new and innovative drugs. What we have heard, however, is that certainty, predictability and transparency oftentimes do not characterize the FDA’s approval process, frustrating both the drug sponsors and the public, who are waiting for treatments and cures to everyday maladies, chronic illnesses, and terminal diseases.”

President and CEO of OncoMed Pharmaceuticals Paul Hastings testified, “When it comes to venture-backed start up biotechnology discovery companies, our industry is facing a crisis. Regulatory uncertainty, longer drug development timelines, and an increasing regulatory and Congressional focus on risk instead of reward in pharmaceutical innovation deters limited partners from investing in biotech venture capital firms and subsequently deters venture capitalists from investing in biotechnology discovery companies.”   Explaining why this is important to the job market, Hastings noted that bioscience  “accounts for over 7 million direct and related jobs.”

Chairman Fred Upton (R-MI) said, “Another area of concern is the risk/benefit analysis used by FDA when approving drugs and whether the agency is striking the right balance on this delicate issue. There are concerns that FDA is failing to consider the views of patients who need access to life-saving drugs, including those drugs that carry some risk. Our goal must be to ensure America remains the leader in medical innovation. When the law works properly, this field creates new jobs and ensures American patients have access to the best therapies available.”

Rep. Sue Myrick (R-NC) and Rep. Brett Guthrie (R-KY) addressed the risk/benefit analysis specifically and questioned Woodcock on the recent decision by the FDA, currently under appeal, that the cancer-fighting drug Avastin would no longer be approved for the treatment of metastatic breast cancer. Despite countless testimonies from breast-cancer patients, Woodcock suggested FDA’s rationale was that studies failed to show a “better quality of life of the people or longer life. That does not mean that Avastin is not an active drug perhaps for some women, but we do not know what women.”

Rep. Michael C. Burgess, M.D. (R-TX) countered Woodcock’s explanation by pointing out a lack of experts on the deciding panel.

“Just looking at the list of people who were on the advisory panel last week who rendered this opinion, I don’t see anyone that would have had the ongoing daily treatment of breast cancer patients under his or her control. You had a lot of experts and a lot of oncologists, but I didn’t see a specific specialist in the specialty of metastatic breast cancer,” said Burgess.

Marc Boutin, of the National Health Council, suggested the FDA improve the process by “developing and implementing a plan to integrate a benefit-risk framework in the drug review process that places the drug’s intended recipient into the equationFor patients with a rare or incurable condition, especially those with few or no treatment options, restricting access to a new drug is potentially devastating.”


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