With Polls Closed and Votes Counted, What's in Store for the Device Industry?
BY LAUREN UZDIENSKI, NOVEMBER 5, 2008
The morning after this historic election, President-Elect Barack Obama and an incoming Democratic Congress promise government-wide change and progress. How will the medical device industry be affected by the new administration? While details of the new administration's healthcare proposals are yet to be revealed, Congressional composition, looming legislation and rumors of potential Cabinet and agency appointments could set the tone.
As of today, the Senate will have 56 Democratic seats (short of a 60-seat filibuster-proof supermajority) and 44 Republican seats. In the House, the Democrat/Republican ratio is 254-173, though there are several seats that are still undecided. The MDMA suggested in an e-mail to members this morning that a Democratic majority in Congress and a Democrat in the White House could mean less Congressional intervention with the FDA - the majority party tries to avoid addressing concerns in a public setting, though the lack of Congressional hearings could free up time and resources for increased investigations.
As for pending legislation, the 111th Congress is expected to address the Physician Payment Sunshine Act, which would require physicians to disclose payments received from industry. The information would be available on a website. Pricing could also become publicly disclosed if the Transparency in Medical Device Pricing Act, also introduced by Grassley, passes. The Patent Reform Act as well as the Medical Device Safety Act, which would overturn the Supreme Court's recent preemption ruling for medical devices in state liability cases, will also be under consideration by the incoming Congress.
Additionally, the WSJ Health Blog posted a list of potential heads of HHS and the FDA this morning. Among the names rumored to be under consideration for the HHS post: former Senator Tom Daschle, former NIH director Harold Varmus or DNC Chair Howard Dean. As for commissioner of the FDA, Steven Nissen, a Cleveland Clinic cardiologist who has been affiliated with the Obama camp, has been named as a contender. The Journal implies that Nissen has joined Sen. Grassley in questioning the relationship between the FDA and industry. Also on the Journal's list are Mike Taylor, former deputy FDA commissioner under Clinton; Mary Pendergast, also a former deputy commissioner; and Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research.
