New President Elected, Now What?

The device industry has mane concerns, but changes will happen under President-elect Barack Obama's watch?The industry is already abuzz with speculations about who will be nominated for the position of FDA commissioner. Among the numerous rumored candidates are Steven Nissen, MD, chair of the department of cardiovascular medicine at The Cleveland Clinic; Susan Wood, PhD, former director of FDA's Office of Women's Health; and Josh Sharfstein, a licensed pediatrician and the commissioner of Baltimore's public health department (along with being former staffer to Oversight Committee Chairman Henry Waxman).As for the next Secretary of Health and Human Services, former senator Tom Daschle (D--SD) has been named as a possibility. Other sources suggest former presidential hopeful Howard Dean, MD, now the chairman of the Democratic National Committee, and Kansas Governor Kathleen Sebelius. We can expect to see an announcement of the nominees much closer to the inauguration.During a recent meeting held by AdvaMed, its government affairs team named several issues on the agenda for the next Congress. Controversy surrounding federal preemption for Class III PMA-approved devices will continue. Last spring's Riegel vs. Medtronic decision effectively affirmed existing statutory and regulatory framework for regulating such devices, and then spurred legislation in the House and Senate to reverse the Riegel decision. According to the AdvaMed team, this is just one example of how preemption issues will be appearing across various industries and at the forefront of the agenda's of trial lawyers, consumer groups, and other organizations.More scrutiny, at both the federal and state level, will be placed on industry's disclosure of physician payments as well as payment limits. Congress is also expected to stronger focus on the direct-to-consumer advertising of devices next year (something traditionally examined in the drug industry).Other areas up for discussion include the comparative effectiveness program--research that is supposed to help doctors and patients make treatment decisions by comparing different treatments, import safety, and patent reform. Potential changes are also in store for 510(k) legislation (a report by the Government Accountability Office examining the program is expected soon).