Drug Attorneys

Bashing big pharmaceutical companies is such the fashion in Washington that it is hard to see how the environment for drug and medical device companies can deteriorate more. But if Sen. John Kerry’s campaign rhetoric matches his governing style, then on Nov. 2 things could get much worse for the scientists and companies that make medical products.

While a Republican Congress can tie Kerry’s hands when it comes to new legislation, Team Kerry can hobble medical product makers with costly new regulatory requirements by controlling of the Food and Drug Administration and Medicare program–the two administrative agencies that regulate the development and pricing of new medical products.

As the biotech industry publication BioCentury recently noted, Kerry’s appointees to the helm of the FDA and the Centers for Medicare and Medicaid Services, not to mention the Secretary of Health and Human Services, could prove to be his most enduring impact on America’s health care. The buzz on possible health secretaries in a Kerry cabinet includes former Vermont governor and Democratic presidential candidate Howard Dean and Iowa Governor Tom Vilsack. Dean, for one, was a brash advocate of drug price controls when he campaigned for the presidency, and Vilsack has favored the same through his support for importing Canadian drugs and, with them, Canadian price caps.

Special Offer: Forbes/Gottlieb Medical Technology Investor, will provide critical insights in health care, biotech and medical devices to investors, executives and policymakers. Click here for information about becoming a Charter Subscriber.
For FDA Commissioner, the outspoken Cleveland cardiologist Eric Topol’s name has surfaced. Topol came into the public spotlight most recently with some sharp criticism of FDA senior staff for their handling of the withdrawal of the popular painkiller Vioxx, marketed by Merck (nyse: MRK - news - people ). On the cusp of the presidential election, Topol’s antagonism against Bush’s FDA lifts his profile in Democratic circles and gives him an early audition for the Kerry FDA post. That may have been the point.

And for the head of Medicare and Medicaid, speculation surrounds Chris Jennings, one of the architects of President Bill Clinton’s attempted takeover of the American health care system, also known as “Hillarycare.” Jennings was making his trade as a lobbyist to some of the big health care services companies, but is reported to be advising the Kerry campaign on Medicare issues.

What trouble could such a cast of characters spell for medical innovation and new product development? Making big changes is tough without new legislation. But new heads of FDA and Medicare under a Democratic president will have the opening to implement policies that have been on the shelf for the last four years–ready to be sprung once a friendly administration comes to town.

More : forbes.com

This entry was posted on Tuesday, January 29th, 2008 at 10:14 pm and is filed under Drug Attorney, Drugs & Medical Devices. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.