FDA: Dissidents, an Acting Commissioner and Deja Vu All Over Again?

Yesterday brought news that FDA's chief scientist and deputy commissioner Frank Torti would assume the role of acting commissioner within FDA. (More on this from the WSJ blog). Great, he seems uniquely qualified, has a strong scientific background. At the Agency's first science writers symposium last November, he was both responsive and gracious.

But...does FDA need any more "acting commissioners?"  Haven't acting commissioners and unhappy employees been the two leitmotifs defining the Agency for the past decade?

No doubt you all read the news last week that nine scientists within the FDA's Center for Devices and Radiological Health had contacted President-Elect Obama's team with complaints alleging ongoing managerial incompetence, poor morale and conflicts of interest.  Below, an excerpt from the January 8 Associated Press article.

..."Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

As far as I can see, the string of complaints and signs of poor morale all began after President Reagan laid off so many FDA reviewers and inspectors at a critical time when biotech was growing, AIDS had become a major concern, and the Agency faced many unfunded or underfunded mandates on a budget that remained at roughly the same level for years.

The first major explosion was the generic drug scandal of 1989, followed by the reassignment of Commissioner Young. 

Flash forward to the indecisive Crawford "acting commissioner' years and allegations of politically based decisions. 

Then Vioxx and David Graham. Then the unfortunate "locker room" reference attributed to FDA Administrator Dr. von Eschenbach 2007, then admonishment by Rep. John Dingell. 

...Followed by more letters from 8 FDA scientists to von Eschenbach and a letter from FDA scientists to Congress. Then the denouement: the heparin scandal and the Commissioner's humiliating dressing down by Dingell.

Despite the negative news, FDA has taken some very concrete steps to improve, via serious recruiting efforts and staff consolidation in one central location.

One hopes that Dr. Torti's assignment will soon become permanent, or that another permanent Commissioner is named soon. Just last week came rumors of another possible contender: Jane Henney, a professor of medicine at the University of Cincinnati who previously served as Deputy Commissioner and as Commissioner under President Clinton.  For one hundred reasons to support her, and commiserate with any FDA Commissioner, just tune in to this Kaiser webcast and hear someone who is poised, articulate and well aware of the funding and political challenges that go along with the job.

When she was Chief Medical Officer, CDER Director Janet Woodcock had pledged to promote an atmosphere of open and scientific debate within the Agency, and to listen to and address employee grievances. Then she was abruptly reassigned...

She'd make a great Commissioner, but she's been an insider during these stressful years, and political pressures may call for a clean sweep and someone far removed from the "locker room." That description would definitely apply to Dr, Torti, who was only recently appointed.

Whoever assumes the helm will have a much easier time than any recent Commissioner, just based on the consolidation, recruitment efforts and new White Oak facilities in Silver Spring.  It's always easier to run a unified, cohesive organization.

We'll feature more on this site shortly, and the science symposium, on our web site.

It's understandable that FDA reform should take a low priority on Mr. Obama's list of urgent problems to solve.  But last year, the President-Elect professed some admiration for the spirit of Ronald Reagan's leadership.  Let's hope that doesn't extend to FDA, which needs support and strong leadership more than ever.

AMS