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| FDA Commissioner Margaret Hamburg |
Margaret Hamburg gave a forceful recounting of her tenure at the agency in her final formal remarks as outgoing FDA commissioner.
The March 27 speech at the National Press Club in Washington, DC, seemed designed to hand the baton off smoothly to FDA Chief Scientist Stephen Ostroff, who has been widely cited as her presumptive replacement.
"Regulation, when it's done right, is not a roadblock," she said. "Smart, science-based regulation instills consumer confidence in the products and treatments. It levels the playing field for businesses. It decreases the threat of litigation. It prevents recalls that threaten industry reputation and consumer trust."
Hamburg insisted that safety and innovation are not mutually exclusive, a position that she implied is not widely understood on Capitol Hill via an anecdote from her 2009 confirmation hearing. At that time, some U.S. congressional representatives enumerated the number of times she said the words "safety" and "innovation" in order to determine which she favored more.
The commissioner devoted a large portion of her speech to recounting her success in improving the regulatory environment for the biopharma industry. "FDA approves drugs faster, on average, than all other advanced nations, and, the vast majority of the time, the U.S. is the first country in the world to approve important and novel medicines," she said.
Hamburg touted the proliferation of accelerated pathways that flourished during her 6-year term. Last year, the agency had its highest number of approvals in more than 20 years. The majority of these were reviewed under one of the expedited review pathways, such as fast track, priority review, breakthrough therapy designation and accelerated approval.
She encouraged the biopharma industry to tackle big scientific problems, such as discovering treatments for Alzheimer's disease, rather than point fingers at regulators for their absence. "It is foolish, in fact dangerous, to believe that reducing regulatory standards will make new treatments and inventions appear if the science is not there. Alzheimer's I think is a good example. I've heard comments of late that something must be wrong in FDA because we're not approving as many drugs for Alzheimer's as we are for cancer, and we're certainly not doing it as quickly. Yet the reality is not the problem of unnecessary hurdles, but the need for medical research to increase our understanding of the underlying disease process," Hamburg said.
On medical devices, she equivocated a bit. The U.S. still lags behind Europe in medical device approval times, although an accelerated pathway for critically necessary devices is in the works.
"We need to continue to look at how we regulate the world of devices because it is getting increasingly complex on one end, and then there's a whole set of other devices that really don't need much attention. This is an area where I don't think that the U.S. has gotten it completely right. I don't know that the European Union has gotten it completely right. It's an area that we need to continue to learn more about," Hamburg said.
She also noted the ongoing, ambitious unique device identification initiative, which she said will help drive understanding of the risks and benefits associated with the use of various devices.
The industry as a whole has largely been pleased with Hamburg's tenure, which was marked by increasing cooperation with the private sector and attempts to make faster regulatory decisions. Hamburg underscored the importance of continuing to work with industry, saying, "We need to understand those products that they make and we need to have full and open exchange of information, and in many instances, there's great value in having industry, academia and government actually work together in shaping research in critical areas."
The speech seemed designed to reaffirm the agency's importance and protect the regulations that keep consumers safe from harmful medical products and tainted food. A defense of the agency is timely and critical, since the new FDA commissioner will face the congressional 21st Century Cures Initiative to overhaul regulation of the healthcare industry, which is likely to relax some regulations that industry finds onerous. Hamburg expressed concern about the potential legislation, which is targeted for passage by year end.
She worried that the legislation would create "unfunded mandates" for an agency she described as already chronically underfunded, and said, "There's a misperception that you might be able to speed up innovation by lowering the standards for safety and efficacy, and I think that would be a terrible mistake that would not only just damage patients, but industry as well."
Hamburg retires on April 3. She said she has received offers to join the boards of some biopharma companies, but that she is in no rush to sort out her next move.
- read coverage of Hamburg's speech from the National Press Club
-- Varun Saxena (email | Twitter)