FDA Vulnerable To Meddling In Climate Of Distrust – Commish Hamburg

An atmosphere of distrust in government makes FDA vulnerable to congressional meddling, Commissioner Margaret Hamburg suggested in a July 25 presentation to consumer group Public Citizen.

There has been a mixed history of trust in the agency, she noted, and currently, with members of Congress pushing for limited government, the commissioner has concerns.

The Republican-controlled House prioritized limited government in its fiscal 2012 appropriation for FDA, which includes "some amendments that certainly raised red flags for me," Hamburg remarked.

Among those are amendments that prohibit FDA from using appropriated funds to regulate the abortion pill RU-486 (mifepristone), which the agency approved in 2000 for termination of early term pregnancy, or approve genetically engineered salmon.

Another amendment Hamburg found troubling – requiring FDA to base its regulations and guidance on "hard science" – did not make it into the final House bill (Also see "House Cuts WIC Funding In Appropriations Bill" - Pink Sheet, 20 Jun, 2011.).

Hamburg said the "hard science" concept "sounds like a good idea, but nobody really knows quite what that means and it clearly could have very, very concerning implications for our ability to take actions in a whole range of critical areas."

"It's very worrisome to me that we would start to see these kinds of potential actions focused on very specific products that would ... hinder our ability to address important issues," she said.

Quieting The “Drumbeat” Of Criticism

Increasingly heated complaints that FDA is stifling medical product development could undermine public confidence in regulatory standards and approved products, Hamburg said.

As in other recent speeches, she rejected the notion that FDA is too slow to approve new drugs and devices. However, she took her July 25 remarks a step further, suggesting that the increasingly ugly tone of the debate could result in negative repercussions for the approval process.

FDA is under growing pressure from industry, the venture capital community, patient groups and some lawmakers to change its operations in a way that helps to spur new product development.

Proposals from biotech and VC industry representatives have included approving products based on a “weight of the evidence” standard, incorporating innovation in FDA’s mission statement and placing an innovation advocate on agency advisory committees.

At the BIO International Convention in June, Hamburg said the agency is looking at different approval pathways to get drugs to market more quickly (Also see "FDA Thinking "Seriously, Deeply" About Range Of Approval Strategies – Hamburg" - Pink Sheet, 4 Jul, 2011.).

At the Public Citizen forum, the commissioner expressed disconcertment over “an increasing drumbeat of concerns raised from certain quarters about the FDA as a bureaucratic regulatory agency impeding innovation.”

She noted that FDA has been accused of compromising the ability to get important new products to market, increasing the cost of medical product development, driving U.S. companies overseas and undermining U.S. global economic competitiveness.

“This discussion is a complex one and we need to take it very seriously. We need to recognize, I think, that advancing innovation is very important for our nation on many levels,” she said.

The commissioner stressed that medical product development involves a “complex ecosystem,” and FDA regulation is only one factor in whether and when new products reach market. She cited a host of other factors at play, including intellectual property concerns, economic policies, underlying investments in science and research and reimbursement issues.

Addressing what she characterized as a “misconception,” the commissioner pointed to results from a recent study published in Health Affairs that showed the agency approved more novel cancer drugs and biologics faster than the European Medicines Agency during an eight-year period.

“It’s also important to recognize that some of this discussion that has become rather heated in certain quarters has the potential to have broader, negative implications for regulatory standards and practices,” Hamburg warned.

"I think that some of this rhetoric and the level of heat associated with it can potentially have negative reverberations in terms of the importance of the FDA's commitment to standards for review and the numbers of new drugs," she said.

"The speed of their delivery matters, but the most important foundation of all that we do, and what really makes a difference in the near and long term for the American people, is that they can have trust and confidence that the products reviewed are reviewed in accordance with science-based standards for safety and efficacy and that our agency has the commitment to that regulatory oversight process that is unwavering."

The rhetoric also impacts the agency's ability to recruit and retain personnel, Hamburg noted.

By Sue Sutter, Carolyn B. Phenicie