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Five Rules Of Thumb About A New FDA Commish
By Ed Silverman (Pharmalot)
November 11, 2008
The ever-insightful RPM Report has a handy list of reminders as we ponder who - just who - might succeed Andy von Eschenbach as the next FDA commissioner. This is the sort of cheat sheet you may have come up with yourself, but you didn’t. So here it is…
1 - The FDA May Be Your Top Priority, But It’s Not Obama’s: There is a financial crisis under way, remember? “In this climate,” RPM writes, “priority goes to economic posts.” You know, the Securities and Exchange Commission and the Treasury Secretary. Besides, the Centers for Medicare & Medicaid Services is usually filled first. And as a post confirmed by the Senate, naming a new commish is guaranteed to take months. So let’s see, about 12 months from now…
2 - It’s Not Necessarily Obama’s Pick, Anyway: Typically, there is some to-ing and fro-ing between White House staff and the new Health and Human Services Secretary when it comes to filling the FDA post, RPM notes. But we don’t know who will head HHS either. And thanks to the uncertain health of Ted Kennedy, the chair of the Senate Health Committee who has historically played a key role in choosing a commish, the process may get still more complicated if he steps down.
3 - It Won’t Be An Insider: Remember a theme from Obama’s campaign? It was ‘change.’ Choosing Janet Woodcock may not make sense because, as RPM correctly points out, this is a plum post and there are just so many jobs to award the loyal and faithful. And since she’s already seen as lthe industry choice, that may actually be a strike against her. If she becomes a flashpoint and prolongs the process, that only works against pharma, anyway.
4 - It Might Be Nissen: Well, maybe. Nothing more than speculation here, but RPM believes the “widespread suggestion that the Cleveland Clinic’s Steve Nissen would be the worst for industry doesn’t hurt him.” As you know, as an Obama advisor he has already been vetted in case he is picked for something.
5 - Nissen Might Not be so Bad After All: Yes, he’s unpopular among many in pharma (see our reader poll), but RPM posits there are reasons he may not be so terrible for the industry. As an insider, he can’t drop bombs anymore, but has to work inside the system. Despite accusations of bias, he actually is closely involved in drug development, since the Cleveland Clinic runs trials.
“Last but not least, there is the Kessler effect: the last time a commissioner was appointed who defined himself by making enemies in industry, he also gave the agency the credibility it needed to establish accelerated approval and the user fee program,” RPM concludes. “Kessler was never popular with industry, and drug companies celebrated his departure. But drug approvals have been in steady decline ever since. Coincidence or not, those were the good old days.”
Thanks to The RPM Report
