Policy

FDA Nominee Addresses Conflicts as Panel Sets Hearing

“I will not participate personally and substantially in any particular matter”

The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015. The FDA is a federal agency of the United States Department of Health and Human Services and has been in commission since 1906. (Al Drago/CQ Roll Call)

The Trump administration’s nominee to lead the Food and Drug Administration, Scott Gottlieb, will resign from positions with drug industry clients and divest himself of stock holdings. Gottlieb said in a letter about his plans to avoid conflicts of interest that he would also recuse himself from decisions affecting firms he is linked to for a year after his confirmation. Gottlieb has ties of some sort to 38 companies.

Gottlieb was an FDA deputy commissioner during the George W. Bush administration. Before and after his government tenure, he worked or consulted for a variety of pharmaceutical interests.

Gottlieb’s ties to industry are under scrutiny as he awaits an April 5 confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.

In the letter to the HHS ethics office, Gottlieb outlined how he would limit his involvement in FDA decisions related to the 38 companies that he is assisting. Those companies include well-known pharmaceutical firms such as GlaxoSmithKline and Bristol-Myers Squibb, as well as smaller drugmakers and firms that invest in promising pharmaceutical research.

Gottlieb said in the letter that within 90 days of confirmation, he will divest his interests. “I will not participate personally and substantially in any particular matter that to my knowledge has a direct and predictable effect on the financial interests of the entity until I have divested it,” he wrote.

Gottlieb also promised he would not perform any outside consulting work during his tenure as commissioner. Though that might be a legal formality, the fact that he even has to say that was enough for critics of his nomination to reaffirm their argument that his industry ties are too tightly knotted to unravel.

“As FDA Commissioner, Gottlieb will be involved in numerous broad policy and regulatory decisions that will impact the financial bottom lines of the many companies that he has been tied to for years,” said Michael Carome, the director of the health research group at Public Citizen. “No amount of recusals will be sufficient to disentangle him from these financial conflicts of interest and ensure that he will put public health before industry profits.”

However, Democrats on the HELP Committee appear to be waiting to hold meetings with Gottlieb before weighing in on potential conflicts of interest. The pharmaceutical ties do not appear to be a concern for Republicans on the health panel who have met with Gottlieb over the past week.

“He has held three roles at the agency, been a practicing physician, and is a cancer survivor, so he understands from nearly every perspective the importance of the agency he’s been tapped to lead,” said committee Chairman Lamar Alexander, R-Tenn., in a statement last week after he met with Gottlieb.

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