March 29, 2017
By Mark Terry, BioSpace.com Breaking News Staff
The Trump cabinet member recusals continue. Although nothing as dramatic as Attorney General Jeff Sessions’ recusal from investigating Russian interference in the 2016 presidential campaign, Scott Gottlieb, the nominee to head the Food and Drug Administration (FDA) has agreed to recuse himself from any agency decisions involving about 20 biopharma companies in his first year.
Gottlieb was a deputy commissioner of the FDA under the George W. Bush administration but he has since worked with several drug companies such as GlaxoSmithKline and Bristol-Myers Squibb as a consultant and public speaker. He has also been a venture partner at New Enterprise Associates and T.R. Winston & Co., which invest heavily in biotech startups.
The New York Times writes, “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.”
The list also includes biotech startups, including Cell Biotherapy, where he is acting as the chief executive officer. He has said he would resign all his positions in the health care industry to avoid any perception of conflicts of interest. Other companies he invested in include American Pathology Partners, Radiology Partners, and U.S. Renal Care.
Although Gottlieb’s agreement to recuse himself and separate out his business conflicts is fairly refreshing considering the Trump administration’s ongoing problems with ethics and conflicts of interest, not everyone is applauding his decisions.
“If you have a commissioner who is that conflicted, recusal is a tricky business,” Susan Wood, a former director of the FDA’s office of women’s health, told the New York Times. “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 decision of the FDA.”
Wood is currently an associate professor of health policy at George Washington University. In 2005, she resigned her FDA post in protest over the agency’s decision to delay over-the-counter approval of the so-called morning-after birth control pill.
In Gottlieb’s defense, his attorney, Leslie Kiernan, told the New York Times, “Every individual who goes into government from the private sector with experience in the industry is going to have recusals.” Broad policy objectives are the commissioners job, Kiernan argues, and typically do not get involved in issues concerning individual companies.
However, even when he was a deputy commissioner in 2005, he ran into some problems with conflicts of interest. He had to recuse himself from a defense plan for the avian flu due to consulting work he did for some of the vaccine manufacturers, including Roche and Sanofi . There was also some reporting at the time over his questioning career FDA staffers about halting a trial for a multiple sclerosis drug and as well as concerns about an osteoporosis drug.
Gottlieb argued at the time that questioning how the agency worked was part of his job.
“The agency was highly politicized by the Bush administration,” Wood told the New York Times, “and he certainly was part and parcel of that politicization. I think for that subset of FDA career staff, the physicians who worked there, I think there was suspicion of everyone in leadership at the time.”
