CQ's Armstrong Discusses Obama's Stem Cell Order, Congressional Health Reform Efforts, Follow-On Biologics, FDA Leadership

Main Category: Stem Cell Research
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry;  Public Health
Article Date: 17 Mar 2009 - 3:00 PDT

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Drew Armstrong, a Congressional Quarterly staff reporter, discusses an executive order that repeals limits on federal funding for embryonic stem cell research, congressional efforts to overhaul the health care system, a bill to allow generic versions of biotechnology drugs and the nomination of an FDA commissioner in this week's "Health on the Hill from kaisernetwork.org and CQ."

Armstrong says that President Obama's executive order to repeal the restrictions on federal funding for embryonic stem cell research requires NIH to develop guidelines for such research within 120 days. Democratic lawmakers are considering legislation, twice vetoed by former President George W. Bush, that would require a majority vote in Congress to undo the new policy, he says. He adds that passing such a bill likely would not be a problem in the House, but that the effort "could be more difficult" in the Senate because Democrats would not be able to prevent a Republican filibuster.

Armstrong also speaks about a joint effort by the chairs of the House Energy and Commerce Committee, the House Ways and Means Committee and the House Education and Labor Committee to bring health care overhaul legislation to the House floor before the August recess. According to Armstrong, this timeline is similar to that put forward by the Senate. He says, "It's important for supporters" of an overhaul to "move fast," because with an issue of such magnitude the president and Congress "only have so long before all the political capital is spent and the will to move a bill disappears." Armstrong also says that Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.) and his staff are working with lobbyists and advocacy groups, but he notes that the committee has not released its own timeline. Nearly all lawmakers support expanding access to health care, covering the uninsured, reducing costs and improving health care as part of an overhaul this year, and there is "still consensus that health care can happen, politically," Armstrong says. However, he adds, Republicans have expressed concerns about Democratic plans to introduce a public insurance option that would compete with private insurers and reduce to Medicare Advantage payments and funding for comparative effectiveness research. According to Armstrong, "It's too early to tell" whether Republicans eventually will vote for a comprehensive bill, but the issues they have brought up appear to be among those that "Democrats are likely willing to compromise on."

In addition, Armstrong discusses a bill (HR 1427) introduced last week by House Energy and Commerce Committee Chair Henry Waxman (D-Calif.) that would allow FDA to approve generic versions of biotech drugs, which supporters say would lower the cost of the drugs and make them more widely available. He says that the bill would create a generics approval process similar to that for traditional drugs. Biotech firms would have five years of market exclusivity for their products, which would be applied retroactively, plus an additional three years if they develop a new use for the drug. Armstrong notes that for biotech companies, this system would not be as favorable as a deal struck with generics makers during the last Congress, which included 12 years of exclusivity. Biotech companies are expected to oppose the bill by claiming it would hurt their ability to develop new drugs and make a profit. Armstrong says that lawmakers whose districts include biotech companies will face pressure to vote against the bill. In addition, he says, "Congress has a lot on its plate right now, and there isn't a timeline for the legislation."

Armstrong also discusses Obama's nomination of former New York City Health Commissioner Margaret Hamburg as FDA commissioner, and Baltimore Health Commissioner Joshua Sharfstein as deputy commissioner. According to Armstrong, the reaction in Congress and among consumer groups to these choices has been "very positive." He adds that senators during their confirmation hearings "won't miss the chance to air their concerns about the agency to Hamburg and Sharfstein" (Armstrong, "Health on the Hill from kaisernetwork.org and CQ," 3/18).

The complete audio version of "Health on the Hill," transcript and resources for further research are available online.

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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