Post-election status of Congress' perspectives on FDA, healthcare

As election-night meeting places get cleaned up, and television broadcasters begin to wonder what will fill in the gap left by billions of dollars of election-year advertising, Washington quickly begins to calibrate both what could happen in the lame-duck session, and how the 113th US Congress will shape up. The law firm Patton Boggs, which styles itself as the “first major law firm to integrate public policy capabilities with a traditional legal practice,” has issued its traditional post-election assessment.

The most significant healthcare and drug-industry result of the election is, of course, the continuation of Obamacare, the Affordable Care Act, the signature legislative activity of the President’s first term. Candidate Romney had threatened to repeal Obamacare on “Day 1;” but now, given the machinery moving into place in Washington and many states (and having passed through Supreme Court review in a squeaker), the program is all but a fait accompli. Patton Boggs expects quick action on the “doc fix” (the annual exercise of CMS reducing Medicare payments per regulation, and Congress re-instituting new funding for physicians’ fees) and the Independent Payment Advisory Board (IPAB), which the Affordable Care Act set up to address healthcare item costs. All this will be happening, however, in the broader context of the sequestration “fiscal cliff,” in which debt reduction is mandated unless new tax and spending policies are adopted.

In the new House, which continues under Republican control, a signal of House’s intentions will be whether they continue to pass repeals of Obamacare, which are guaranteed to fail in the Senate, says Patton Boggs.

FDA , the budget for which President Obama “been unusually protective,” will have some sequestration issues to be concerned with, but the passage of the FDA Safety and Innovation Act (PDUFA V) has already begun to expand its user-fee system to generic pharmaceuticals and medical devices. Patton Boggs expects a “schizophrenic” oversight of FDA in Congress, with Republican House committees tearing into purported FDA over-regulation, and Democratic Senate committees highlighting claimed inabilities to protect public health without more authority and resources. The law firm also says that “we are probably only a crisis or two away from a mandate at the federal level” for track-and-trace legislation, while noting that the current crisis over contaminated, compounded pharmaceuticals will likely receive congressional committee attention if not legislation. Track-and-trace regulation is a decades-long battle in Washington, and was an element of PDUFA V up to when the law was passed; a new effort is already under way and might actually be voted on during the lame duck session.

Among Congressional committees, Patton Boggs expects Senator Tom Harkin (D-IA) to continue as chairman of the health, Education, Labor and Pensions (HELP) Committee, but ranking minority member Mike Enzi (R-WY) might be replaced by Larmar Alexander (R-TN). The House Energy and Commerce Committee will have Fret Upton (R-MI) and Henry Waxman (D-CA) continue as chair and ranking member.