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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."