Updated: Reflections on Changes Inside-the-Beltway & at FDA

January 5, by John Kamp — “The times are a changing” at FDA as Republicans take over the House and the Democrats maintain a fragile majority in the Senate. Such divisions bring much noise, especially in the two years before a Presidential election, but few bipartisan agreements in the form of legislation. The announcement by FDA Deputy Commissioner Joshua Sharfstein that he is accepting the job as head of health policy for the state of Maryland highlights much of the change . Not surprisingly, the resignation has insiders engaging in all sorts of speculation. Here’s my view of what matters. Add yours in a comment below.

January 6 Update — Today, Commissioner Margaret Hamburg announced that Best prices on brand viagra John Taylor will serve as Acting Deputy Commissioner in Sharfstein’s spot for 60 days.  Meanwhile, Hamburg is looking to re-organize the Commission senior office staff . Taylor is exactly the sort of FDA vet needed  as the FDA faces the new challenges from Capitol Hill and the elsewhere. Taylor has worked both inside and outside the FDA on these issues for nearly three decades and has exactly the sort of wisdom and expertise needed. Stay tuned as we follow and comment on these developments.

Meanwhile, check out some of the reports in the trade and general press. One of the better reports is in Pharmalot: Matt Arnold was one of the first out with this article at the following address quoting Peter Pitts and me:

All in all, I think it was a good move for Sharfstein, a Harvard educated doctor with a career in public health. I’ve already said we’re likely to see him back on the federal payroll before the end of the Obama era, but the Maryland job just enhances his resume.

But, I worry that his departure leaves a huge hole in the staff of Commissioner Peggy Hamburg. Despite Sharfstein’s anti-industry reputation and stint as a staffer for Congressman Henry Waxman, Sharfstein brought intelligence and wisdom to the agency. Some of his best moments were in House and Senate hearings where he often calmly and ably responded to sharp questioning by Republican Members. But, then of course he was always protected from the worst by his old Democratic colleagues, including Congressman Waxman, then head of the House Commerce Committee.

The coming two years will be tougher for the FDA senior staff who appear in Congress. Several Members, including California Congressman Issa, Republican Head of a testy government oversight committee, will be out to make their mark against any Democratic appointee, especially from the widely followed FDA. By moving to Annapolis, Sharfstein avoids at least two years of nasty House oversight hearings. Dr. Hamburg doesn’t have the extensive Hill experience that guided Sharfstein, but she better get it soon. I was the FCC Congressional Affairs Director while the Congress was divided. Politics often trumped science and facts. Indeed, I have scars on my back and my soul from those days. During many hearings, it seemed like every Member shot first with hostile questions and then went out of the way not to listen to the answers. Things have only gotten nastier since.

Regardless of anyone’s politics, we all need the FDA to be and to be viewed as strong and smart. While, Dr. Hamburg must choose a deputy with great knowledge of public health and FDA, she also needs someone with Hill experience who will be respected by the thought leader Members in both parties. Three such candidates quickly come to mind. Kay Holcombe, now with Genzyme, commanded the respect of both parties while working on the Democratic staff of Committee Chairman Dingell and as FDA liaison for Commissioner Kessler. Similarly, Marc Scheinison, now with the Alston and Bird law firm, and Mary Pendergast, a consultant, represented FDA in several roles while maintaining a stance of substance over politics. We need these sorts of people to help FDA and citizens get the best in must pass legislation, including PDUFA 2012.

Patients, medical professionals and industry all have a stake. Think it over, then add your own ideas viagra