Hamburg Says Distrust Leaves FDA Vulnerable To Meddling
This article was originally published in The Tan Sheet
|
An atmosphere of distrust in government makes FDA vulnerable to congressional meddling, says Commissioner Margaret Hamburg. There has been a mixed history of trust in the agency, but times like the present – with members of Congress pushing for increasingly limited government – are particularly worrisome, she said July 25 in a presentation to the consumer group Public Citizen. 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 said. Among these 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 measure (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 continued. Quieting The "Drumbeat" Of Criticism Increasingly heated complaints that FDA regulation is stifling medical product innovation actually could undermine the approval process by reducing public confidence in agency regulatory standards and approvals, Hamburg said. She continued the defense she has made in other recent speeches against claims that FDA is too slow to approve new drugs and devices. However, she took her remarks a step further, suggesting that the increasingly ugly tone of the debate could result in negative repercussions for the approval process. The commissioner's remarks suggest both a growing fatigue within agency leadership over complaints that the agency is hindering the speed of new product development as well as heightened concern about the tenor of the rhetoric. FDA is coming 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. Hamburg said the blame-laying at FDA's feet worries her. "You may be aware of an increasing drumbeat of concerns raised from certain quarters about the FDA as a bureaucratic regulatory agency impeding innovation." FDA has been accused of compromising the ability to market important new products, increasing the cost of medical product development, driving U.S. companies overseas and undermining U.S. global economic competitiveness, she said. "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. Yet, medical product development involves a "complex ecosystem," and FDA regulation is only one factor in whether and when new products reach market, she said. She cited other factors at play, including intellectual property concerns, economic policies, underlying investments in science and research and reimbursement issues. "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. Unfounded Complaints Can Hit Performance Not only are the complaints about FDA sluggishness unfounded, they are potentially harmful, she asserted. "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. Responding to a question about turnover in the Center for Devices and Radiological Health, she said: "The more embattled FDA becomes and the more difficult the work environment, the harder it will be to recruit and retain as well. So that's another reason why I would like to see the tone of some of the discussions get a little less heated and a little more focused on what do we really need to do and how can we get that important work done." |