12:00 AM
Nov 08, 2010
 |  BioCentury  |  Politics, Policy & Law

Surfing the GOP tidal wave

U.S. elections: More sympathetic for biopharma; but more reliance on user feesFDA, BIO, PhRMA dickering over longer review times in PDUFA V

While the biopharmaceutical industry's long-term agenda for the new Congress centers on PDUFA reauthorization, it will be at least a year before lawmakers turn their attention to the user fee legislation. In the near term, lawmakers will consider other issues importance to the life sciences community, ranging from budgets for science and oversight to implementation of healthcare reform.

For both sets of issues, Republican victories in last week's congressional elections cut two ways. With the GOP in control of the House, it is far less likely that PDUFA will become a vehicle for piling on new drug safety regulations, or imposing comparative effectiveness hurdles.

But the Republican majority in the House could create stress at FDA by targeting it for budget cuts, attempting to restrain any agency initiatives that look like an extension of government regulatory reach, and forcing FDA's political leadership to devote time and resources to responding to aggressive oversight.

Rep. Eric Cantor (R-Va.), who is set to become House Majority Leader, last week released a plan that calls for reducing government payrolls and expenditures to 2008 levels and creating a "culture that prioritizes oversight."

"One thing that could be troubling for FDA in the new Congress is the potential for a lot of oversight hearings and subpoenas," said Frank Sasinowski, a partner at the law firm Hyman, Phelps & McNamara P.C. and chairman of the National Organization for Rare Disorders. "Strict oversight of the Obama administration's FDA Commissioner is too tempting a target for the Republicans to pass up."

In a divided government, executive agencies like FDA and CMS "are forced to negotiate with the other party by virtue of congressional control over appropriations and its oversight powers," noted Dan Mendelson, CEO of Avalere Health, a healthcare consulting company. Mendelson experienced divided government when he served from 1998 to 2000 as associate director for health in President Clinton's Office of Management and Budget.

FDA's plans to broaden its regulation of laboratory-developed tests and revamp the review process for other medical devices have already attracted the attention of Republican staffers.

Every aspect of the Patient Protection and Affordable Care Act (PPACA) will come under scrutiny, as Republicans have vowed to first try to repeal the law and then attempt to eliminate or replace it piece by piece.

FDA's plan to collaborate with CMS on a voluntary parallel review initiative also will be on the radar screen (see BioCentury, Oct. 18).

In addition, House Republicans are certain to attempt to derail or defund the Independent Payment Advisory Board, now dubbed the "IPAD," which was created in PPACA to make Medicare cost-cutting proposals that would automatically be adopted unless Congress enacts alternative cuts of the same size.

Republicans are also skeptical of the law's mandates for government to conduct and disseminate comparative effectiveness research.

Capitol Hill hearings on the biosimilars pathway created in PPACA are likely as well.

Musical chairs

Committee chairmen control the legislative and oversight agendas in Congress, so the Washington offices of biopharma companies are watching with great interest the three-way fight to lead the House Energy and Commerce Committee, which has jurisdiction over FDA operations.

Rep. Joe Barton (R-Texas), the ranking Republican on the committee, has announced he'd like to become chairman. This would require a waiver from term limits for committee leadership that incoming Speaker John Boehner (R-Ohio) is unlikely to grant. Barton is politically radioactive after publicly apologizing to BP for the Obama administration's treatment of the company in the aftermath of the Gulf of Mexico oil spill.

John Shimkus (R-Ill.) is also in the running,...

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