Time to Go?

by PotomacFeverish 

In the first of what may be numerous resignations, Scott Gottlieb, MD has announced that he will leave his post as Deputy Commissioner at the Food and Drug Administration.  He has been at the center of the political science practiced at the FDA as noted by Time last year:

Nowhere in the federal bureaucracy is it more important to insulate government experts from the influences of politics and special interests than at the Food and Drug Administration, the agency charged with assuring the safety of everything from new vaccines and dietary supplements to animal feed and hair dye. That is why many within the department, as well as in the broader scientific community, were startled when, in July, Scott Gottlieb was named deputy commissioner for medical and scientific affairs, one of three deputies in the agency’s second-ranked post at FDA.

His official FDA biography notes that Gottlieb, 33, who got his medical degree at Mount Sinai School of Medicine, did a previous stint providing policy advice at the agency, as well as at the Centers for Medicare and Medicaid Services, and was a fellow at the American Enterprise Institute, a conservative think tank. What the bio omits is that his most recent job was as editor of a popular Wall Street newsletter, the Forbes/Gottlieb Medical Technology Investor, in which he offered such tips as “Three Biotech Stocks to Buy Now.” In declaring Gottlieb a “noted authority” who had written more than 300 policy and medical articles, the biography neglects the fact that many of those articles criticized the FDA for being too slow to approve new drugs and too quick to issue warning letters when it suspects ones already on the market might be unsafe. FDA Commissioner Lester Crawford, who resigned suddenly and without explanation last Friday, wrote in response to e-mailed questions that Gottlieb is “talented and smart, and I am delighted to have been able to recruit him back to the agency to help me fulfill our public-health goals.” But others, including Jimmy Carter–era FDA Commissioner Donald Kennedy, a former Stanford University president and now executive editor-in-chief of the journal Science, say Gottlieb breaks the mold of appointees at that level who are generally career FDA scientists or experts well known in their field. “The appointment comes out of nowhere. I’ve never seen anything like that,” says Kennedy.
Gottlieb’s financial ties to the drug industry were at one time quite extensive. Upon taking his new job, he recused himself for up to a year from any deliberations involving nine companies that are regulated by the FDA and “where a reasonable person would question my impartiality in the matter.” Among them are Eli Lilly, Roche and Proctor & Gamble, according to his Aug. 5 “Disqualification Statement Regarding Former Clients,” a copy of which was obtained by TIME. Gottlieb, though, insists that his role at the agency is limited to shaping broad policies, such as improving communication between the FDA, doctors and patients, and developing a strategy for dealing with pandemics of such diseases as flu, West Nile virus and SARS.
Would he ever be involved in determining whether an individual drug should be on the market? “Of course not,” Gottlieb told TIME. “Not only wouldn’t I be involved in that … But I would not be in a situation where I would be adjudicating the scientific or medical expertise of the [FDA] on a review matter. That’s not my role. It’s not my expertise. We defer to the career staff to make scientific and medical decisions.”
Behind the scenes, however, Gottlieb has shown an interest in precisely those kinds of deliberations. One instance took place on Sept. 15, when the FDA decided to stop the trial of a drug for multiple sclerosis during which three people had developed an unusual disorder in which their bodies eliminated their blood platelets and one died of intracerebral bleeding as a result. In an e-mail obtained by TIME, Gottlieb speculated that the complication might have been the result of the disease and not the drug. “Just seems like an overreaction to place a clinical hold” on the trial, he wrote. An FDA scientist rejected his analysis and replied that the complication “seems very clearly a drug-related event.” Two days prior, when word broke that the FDA had sent a “non-approvable” letter to Pfizer Inc., formally rejecting its Oporia drug for osteoporosis, senior officials at the FDA’s Center for Drug Evaluation and Research received copies of an e-mail from Gottlieb expressing his surprise that what he thought would be a routine approval had been turned down. Gottlieb asked for an explanation.
Gottlieb defends his e-mails, which were circulated widely at the FDA. “Part of my job is to ask questions both so I understand how the agency works, and how it reaches its decisions,” he told TIME. However, a scientist at the agency said they “really confirmed people’s worst fears that he was only going to be happy if we were acting in a way that would make the pharmaceutical industry happy.”
The Oporia decision gave Pfizer plenty of reason to be unhappy: the drug had been expected to produce $1 billion a year in sales for the company. Pfizer’s stock fell 1.4% the day the rejection was announced. The FDA has not revealed why it rejected the drug, and Pfizer has said it is “considering various courses of action” that might resuscitate its application for approval.

This story generated little follow-up here in Washington last year, and that might have changed with the incoming Congress.   But if Dr. Gottlieb is not at the FDA, he will be have a much lower profile for any Congressional investigation of the problems at FDA.

 PotomacFeverish is a Washington, DC based scientist