Biotech Manufacturers Face New Political Landscape - Changes on Capital Hill create uncertainty for healthcare reform, drug regulation, and biomedical research. - BioPharm International


Biotech Manufacturers Face New Political Landscape
Changes on Capital Hill create uncertainty for healthcare reform, drug regulation, and biomedical research.

BioPharm International


The Republican takeover of the House puts them in charge of the key committees with oversight of health and biomedical programs, and the new leaders plan to be much less friendly to the Obama administration health officials who run them. The new leaders of the House Energy and Commerce Committee are eager to grill HHS Secretary Kathleen Sebelius and her top aides on healthcare reform cost estimates and the effect of specific new policies on employer coverage, premiums, and benefits. The panel also plans hearings on FDA policies and what new initiatives should be added on to user fee renewal legislation.

Rep. Darrell Issa (R-CA) is in line to chair the House Oversight and Government Reform Committee, where he will be able to issue subpoenas to access desired government documents. At hearings this fall on the FDA's handling of Johnson & Johnson's recall of faulty over-the-counter medicines, Issa criticized the FDA for taking too long to shut down the noncompliant J&J plant and for withholding information sought by committee investigators.

Although Democrats retained control of the Senate, there will be changes in key health-related committees. Sen. Orrin Hatch (R-UT) will be the top ranking Republican on the Senate Finance committee, where he will continue to play a lead role in revising healthcare and crafting relevant pharmaceutical regulatory policies. He replaces Sen. Charles Grassley (R-IA), removing a long-time critic of pharma and the FDA from that position. The Senate Health, Education, Labor, and Pensions (HELP) committee lost two long-term members because of retirement: Chris Dodd (D-CT) and Judd Gregg (R-NH). Chairman Tom Harkin (D-IA) and Mike Enzi (R-WY) will be lead players in crafting FDA user fee renewal legislation.


With Congress unlikely to repeal the ACA, opponents of the law are looking to the courts to do the job; several states are challenging as unconstitutional the main tenet of health reform—the individual mandate for purchasing insurance. A case filed in Virginia challenges the individual mandate directly, while a group of 20 states have filed a case in Florida that opposes the federal government expansion of Medicaid, as well as the individual mandate and insurance market reforms. The federal judges hearing these cases decided recently that the issues deserve further consideration, even though another federal judge dismissed a similar case in Michigan in October 2010. With the more conservative jurists in the south likely to disagree, the issue most likely will end up before the Supreme Court in another year or two—but before the individual mandate is scheduled to go into effect in 2014. All sides—including insurers and payers—agree that without a requirement that everyone obtain healthcare coverage, insurance market reform may be unsustainable.

All of these developments create uncertainty about the prospects of reimbursement for new biomedical therapies, which discourages outside investment in sciences, noted Mark Heesen of the National Venture Capital Association at the October Mid-Atlantic BIO meeting. He and others will be looking to see if Republican leaders are more supportive of policies likely to stimulate small business growth and to address the effect of government regulation on emerging companies.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,

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