FDA chief to step down as Obama's sworn in

It's official: FDA Commissioner Andrew von Eschenbach will step down on inauguration day. The commish announced his plans to FDA staff yesterday, saying that he expects the agency's senior management team to change--at least somewhat--as well. Of course, von Eschenbach pledged to work with President-elect Obama's transition team to ensure a "seamless change in political leadership" at the FDA.

In anticipation of von Eschenbach's resignation, pharma observers have been speculating on his successor. Politicians have weighed in with their opinions, too. Industry and FDA critic Rep. Bart Stupak, for instance, wrote Obama to plead for a complete overhaul in agency management. "Current senior FDA employees are too close with the industries they regulate," Stupak wrote.

Whoever takes over at the FDA will be tackling a tough task. As you know, last fall, the agency's own Science Board said it is ill-equipped to supervise the pharma business, lacking scientific talent, adequate funding, adequate staffing and up-to-date computer systems. And critics have lined up to offer their own critiques, including Congressional reps and committees who've taken issue with FDA's activities on everything from drug safety to advertising to off-label marketing to industry-doctor/industry-regulator relationships.

Then there are myriad safety problems that have arisen over the last couple of years. Take the big heparin recall early this year, which exposed major holes in the agency's oversight of foreign drugmakers and overseas active ingredient manufacturers. The agency has taken some steps toward fixing those problems--including opening new offices in China, where many APIs are made these days--but the new commissioner will still have plenty to do on that score.

- read the Wall Street Journal article

ALSO: One of the contenders for von Eschenbach's post, Baltimore health chief Joshua Sharfstein, gets the profile treatment from his hometown newspaper. Report

Suggested Articles

Mylan and Pfizer's Upjohn have a name for their pending merger: Viatris. Heard that before? So has Mylan, which owns a subsidiary with the same name.

Intercept presented a data analysis that found treatment with Ocaliva led to "early and consistent improvements" in a range of noninvasive tests.

Days before Amarin faces a pivotal FDA vote on its Vascepa expansion, advisors are set to scrutinize the placebo used in its pivotal outcomes trial.