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By Thomas M. Burton 

The Trump administration's nominee to lead the Food and Drug Administration plans to recuse himself for a year from FDA decisions on more than 20 companies, including some drug giants.

Scott Gottlieb in recent years has held positions and received millions of dollars in income as adviser, executive, paid speaker or consultant to the companies, according to financial-disclosure documents he has filed with government ethics officials.

Among the companies are cancer-therapy startups, such as Cell Biotherapy Inc., and large concerns, such as GlaxoSmithKline PLC and Bristol-Myers Squibb Inc.

Much of that work involved assessing the prospects of fledgling companies, investing in some and advising them on medical and regulatory matters.

Dr. Gottlieb, a physician, has provided some of that seed money himself. Other venture capital came from New Enterprise Associates, where he has been a venture partner, and from T.R. Winston & Co., where he has been a managing partner and investment consultant.

The consulting work for GlaxoSmithKline, for which he was paid $87,153 in 2016 through the first two months of 2017, involved helping the company make decisions about drugs in its research pipeline.

In all cases, Dr. Gottlieb pledged to ethics officials at the Office of Government Ethics to recuse himself from involvement with the medical companies at the FDA for a year after resigning positions and divesting his interests.

An FDA commissioner rarely is required to get involved in company-specific decisions, instead directing policy covering entire industries.

Dr. Gottlieb's work with such a wide range of drug firms could provide fodder for Senate Democrats to attack his nomination in hearings scheduled for next week. Unlike some other Trump cabinet members who are relative novices to federal government, Dr. Gottlieb previously served in government, as a deputy FDA commissioner under President George W. Bush.

According to the documents, during 2016 and through March 1, 2017, when the disclosure period ends, Dr. Gottlieb made more than $3 million in gross income. The income included a retainer and bonus of $1.85 million from T.R. Winston, as well as $280,000 as a consulting retainer from New Enterprise and salary of $210,916 from the American Enterprise Institute, a conservative think tank.

Earlier data in a federal database, covering 2013 through 2015, show that Dr. Gottlieb had collected $413,000 from medical companies, mostly in consulting and speaking fees.

Dr. Gottlieb's ties to 19 of the companies in the newer disclosure forms stem from his position with New Enterprise and T.R. Winston.

At New Enterprise, he invested in six early-stage companies specializing in areas such as kidney disease, pathology and radiology. They include American Pathology Partners, Radiology Partners and U.S. Renal Care. He plans to divest interests in all the companies, according to decisions reached with the Office of Government Ethics and ethics officials with the Department of Health and Human Services.

Some critics of Mr. Gottlieb say their concerns focus on his views of FDA regulation -- not his finances.

Jerome Avorn, a Harvard Medical School professor who has extensively studied the drug industry, said, "You can't recuse yourself from your ideology. Scott has been very candid that he would like a lighter regulatory touch" at the FDA.

Dr. Gottlieb has generally advocated for quicker and simpler FDA approvals, a view that aligns him in some ways with President Donald Trump.

Dr. Gottlieb's attorney, Leslie Kiernan of the Washington firm Akin Gump Strauss Hauer & Feld, said, "Every nominee who goes into government from private industry will have some recusals. But Scott brings a unique combination of experience. He understands how startups work, and it's valuable for a regulator to understand this."

At T.R. Winston, Dr. Gottlieb has recently held financial interests in 13 companies, such as Cell Biotherapy, a cancer-research company; Kure, a retailer of vaping products; and Tivorsan Pharmaceuticals, a maker of an early-stage muscular-dystrophy drug.

T.R. Winston often put its own money into such companies and raises other funds from investors.

Dr. Gottlieb also agreed to resign his consultancy relationship with Glaxo, in which he served as a drug-research adviser. He has said he won't be involved in any Glaxo decisions for a year after ending the relationship.

In the case of Bristol-Myers, his disclosures say he "previously provided" consulting services to the company, without stating a dollar figure for income or giving detail. But he pledged to have no official dealings with the company for a year.

Another issue that could raise possible issues concerns 24 speaking honoraria totaling more than $200,000 during 2016 and the first two months of 2017. These include $10,000 from Merck & Co., $11,250 from the Generic Pharmaceutical Association and $11,250 from Biogen Inc.

Write to Thomas M. Burton at tom.burton@wsj.com

(END) Dow Jones Newswires

March 29, 2017 00:15 ET (04:15 GMT)

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