Dr. Scott Gottlieb, President Donald Trump's nominee to the lead the Food and Drug Administration (FDA), drew fire on Wednesday for the millions of dollars he has received from Big Pharma, including the U.S. opioid industry, which he would be charged with regulating.
Though Trump has said he wants to lower drug prices and claims to be concerned about opioid abuse, launching a commission last month to investigate the national epidemic, members of the Senate Health, Education, Labor and Pensions Committee on Wednesday argued that his nomination of Gottlieb belied that rhetoric.
Pointing to recently released financial disclosure documents which show that the former physician and resident fellow at the conservative American Enterprise Institute has received millions of dollars in compensation from more than 20 biopharma and health companies, ranking Democrat Sen. Patty Murray (D-Wa.) said Trump's nominee had "unprecedented financial entanglements with the industries he would regulate."
Similarly, Sen. Chris Murphy (D-Conn.) said: "The worry here is that there will be industry-supported reforms that will find a voice inside of the agency because of your connection to the industry."
"It seems like it would be a big gift to the drug industry," Murphy continued, "being able to use their political donations in order to ultimately put a group of friendlies on a process or commission that decides approval, rather than having that process sheltered from the political process."
Reporting on the disclosures on Tuesday, the Intercept's Lee Fang noted that since the beginning of 2016, "firms involved in the manufacture and distribution of opioids" alone gave Gottlieb $45,000 in payments and speaking fees—some of which are the very same companies being charged with worsening the opioid epidemic in places like West Virginia.
Dr. Andrew Kolodny, co-director of Opioid Policy Research at Brandeis University, warned against Gottlieb's confirmation, saying this week that "[o]ur country is in desperate need of an FDA commissioner who will take on the opioid lobby, not one who has a track record of working for it."
During Wednesday's hearing, Sen. Bernie Sanders (I-Vt.) also questioned why Trump, who has expressed support for allowing lower-cost pharmaceuticals to be imported from Canada, would nominate a commissioner who has voiced opposition to drug importation.
"I find it amazing that Trump says something during the campaign and then appoints people who have radically different ideas," said Sanders, who in February called on the president to "make good on his campaign promises" and support his recently-introduced importation legislation.
In a series of tweets, Sanders further highlighted Trump's pattern of "nominating people who hold the exact opposite views of what he campaigned on."
Trump said pharma is “getting away with murder.” And now his pick to head the FDA is someone who received millions from drug companies.
— Bernie Sanders (@SenSanders) April 5, 2017
Just what we need. An FDA commissioner who has taken millions of dollars from drug companies. This is a disgrace. pic.twitter.com/5xCuDDuO9z
— Bernie Sanders (@SenSanders) April 5, 2017
Another issue that has raised concern is Gottlieb's stance on deregulating the pharmaceutical process, which he partially outlined on a Forbes' op-ed published last year.
During a press call ahead of Wednesday's hearing, Dr. Michael Carome, director of Public Citizen's Health Research Group, said that Gottlieb "is entangled in an unprecedented web of close financial and business ties to the pharmaceutical industry and was no doubt chosen [by Trump] because he is well-suited to carry out the president's reckless, ill-informed vision for deregulating the FDA's review and approval process for prescription medications, including opioids."
In exchange for getting medications to the market faster, he believes that the FDA must be willing to accept a greater degree of uncertainty about the drugs' safety and efficacy at the time of approval.
He also has questioned the FDA's use of risk evaluation and mitigation strategies (REMS) to ensure safe drug use, challenging the FDA's authority to impose requirements for such plans on pharma companies. The FDA currently relies on REMS plans as one tool to try to ensure the safe use of many medications.
Dr. Gottlieb's appointment would further accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients.
What's more, The Hill reported that despite having numerous industry ties, Gottlieb on Wednesday "would not commit" to Murray's request to recuse himself for two years "from FDA matters that directly impact the more than two dozen companies he's tied." Last month he agreed to recuse himself and divest his financial interests for one year.
Regardless of these mounting conflicts and concerns, the New York Times observed that Gottlieb appears "to be headed for confirmation unless some damaging new information turns up."