2017-03-29 14:21:02
F.D.A. Nominee Details Drug Industry Ties

President Trump’s nominee to head the Food and Drug Administration has received millions of dollars in payments from his recent work in the private sector, including firms with ties to drug and other health care companies, according to his federal disclosure forms. He said that if confirmed by the Senate, he planned to recuse himself for a year from any agency decisions involving about 20 health care companies.

The nominee, Dr. Scott Gottlieb, has done a range of work for companies, among them large drug makers like GlaxoSmithKline and Bristol-Myers Squibb, including consulting, public speaking and even acting as chief executive officer in the case of a small start-up. Dr. Gottlieb also has relationships with a host of other small companies he invested in as a venture partner at New Enterprise Associates as well as at T.R. Winston & Co., a bank that is focused on health care investments.

According to the federal ethics filings, Dr. Gottlieb said he would recuse himself from decisions involving all the companies he received payments from, including six companies that he held a financial interest in through his position at New Enterprise Associates, all of them health care providers or lab testing companies that are overseen by the Centers for Medicare and Medicaid Services. He also listed several biotech start-ups that he invested in through T.R. Winston, including Cell Biotherapy, where he serves as the acting chief executive. He said he would resign his positions in the health care industry to avoid any perception of conflict.

Financial disclosure documents show Dr. Gottlieb made more than $3 million in income during 2016 and through March 1 of this year, including $1.85 million from T.R. Winston and $280,000 for consulting for New Enterprise, according to the disclosures, which were earlier reported by The Wall Street Journal. But the investments in T.R. Winston were not all in health care companies and included several energy companies, as well as other companies.

Dr. Gottlieb’s financial relationships with these companies are sure to revive debate over whether someone with such close ties to the industry should be put in charge of an agency that controls its fate: Several consumer groups and others have already criticized his nomination. The issue is also likely to come up in his confirmation hearings in the Senate.

“If you have a commissioner who is that conflicted, recusal is a tricky business,” said Susan F. Wood, the former director of the agency’s office of women’s health, who resigned in protest in 2005 over the F.D.A.’s decision to delay over-the-counter approval of the morning-after pill. She is now an associate professor of health policy at George Washington University. “He’s obviously well trained, he has experience, but my concern is whether he has the strength of will and the commitment to ensuring that actually the best science and the best medicine drives the decisions of the F.D.A.”

“Every individual who goes into government from the private sector with experience in the industry is going to have some recusals,” said Leslie Kiernan, a lawyer for Dr. Gottlieb, who said that his recusal plan was approved by federal ethics officials. She also said that F.D.A. commissioners do not typically get involved in matters involving individual companies. “The key role of the commissioner is to set broad policies for the agency.”

Dr. Gottlieb was just 33 years old when he became a deputy at the F.D.A. in 2005 during the Bush administration. At the time, he had little government experience beyond a handful of previous stints at the F.D.A. and the Centers for Medicare and Medicaid Services. Before that, he had held jobs as a financial analyst and consultant to the pharmaceutical industry. He also wrote newsletters chronicling the biotech industry: the Gilder Biotech Report and the Forbes Gottlieb Medical Technology Report.

Those industry ties soon became a headache. In late 2005, he was forced to recuse himself from discussion of a defense plan for the avian flu, the Boston Globe reported at the time, because of his consulting work for some of the major players in the vaccine market, including Roche and Sanofi. Around the same time, emails that were leaked to Time Magazine showed him questioning career F.D.A. employees over a decision to halt a trial for a multiple sclerosis drug, and expressing surprise when the agency turned down an osteoporosis drug.

At the time, Dr. Gottlieb defended his actions, saying his job required that he ask questions to understand how the agency worked, and that he deferred to career staff on drug approvals.

“The agency was being highly politicized by the Bush administration, and he certainly was part and parcel of that politicization,” Dr. Wood said. “I think for that subset of F.D.A. career staff, the physicians who worked there, I think there was suspicion of everyone in leadership at the time.”

Dr. Gottlieb left the agency in 2007, and quickly returned to the health care industry. He became a partner at New Enterprise Associates, working on the firm’s portfolio of health care investments, and took consulting work at a range of companies, from pharmaceutical giants like Bristol-Myers Squibb and GlaxoSmithKline to start-ups like Cell Biotherapy, an early stage cancer biotech firm that he helped found. Dr. Gottlieb also held seats on a number of corporate boards, including Tolero Pharmaceuticals, a Utah company working on cancer treatments, and MedAvante, which assists pharmaceutical companies with clinical trials.