Donald Trump has nominated Dr. Scott Gottlieb to lead the U.S. Food and Drug Administration (FDA). Observers have noted the possible conflict of interest. Dr. Gottlieb is alleged to have received millions of dollars from the pharmaceutical industry, including the manufacturers of opioid medications.
On Wednesday, March 29, Trump signed an executive order creating a commission, headed by New Jersey governor Chris Christie, to study the problem of opioid addiction and overdose, a growing problem in the United States. White House Press Secretary Sean Spicer was quoted as saying, “Stopping this epidemic is an issue that every American regardless of political background can and must get behind.” Yet the President’s apparent interest in curbing the opioid abuse epidemic would seem to conflict with his nomination of Dr. Gottlieb.
Members of the Senate Health, Education, Labor, and Pensions Committee made such an argument on Wednesday, April 5. They referred to an Executive Branch Personnel Public Financial Disclosure Report filed regarding Dr. Gottlieb which appear to show that Gottlieb received compensation from more than 20 pharmaceutical companies totaling several million dollars. More than $45,000 came from opioid manufacturers alone.
According to Senator Patty Murray (Democrat-Washington State), Gottlieb’s appointment to Commissioner of the FDA would create “unprecedented financial entanglements with the industries he would regulate” for Gottlieb. She asked for Gottlieb to commit to recusing himself “from FDA matters that directly impact the more than two dozen companies he’s tied,” but Gottlieb declined to make such a commitment. Gottlieb had previously agreed to make a one-year recusal from such cases in an ethics agreement made public in March 2017.
Chris Murphy, a Democrat senator from Connecticut, added, “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.” Senator Murphy went on to say, “It seems like it would be a big gift to the drug industry, 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.”
Brandeis University’s Opioid Policy Research Center co-director Dr. Andrew Kolodny spoke out against Gottlieb’s confirmation as well. Kolodny said that the U.S. “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.” Some of the same opioid manufacturing and distributing companies that are on record as having made payments to Gottlieb are the companies accused by former Drug Enforcement Administration (DEA) official Joseph Rannazzisi of lobbying Congress against the best interests of American citizens.
Rannazzisi, in an interview with the U.S. edition of the U.K.’s Guardian newspaper, cited the recent Ensuring Patient Access and Effective Drug Enforcement Act. The former DEA official said the act “requires the DEA to warn pharmacies and distributors if they are in breach of regulations and to give them a chance to comply before licenses are withdrawn.” Rannazzisi continued, “This doesn’t ensure patient access and it doesn’t help drug enforcement at all. What this bill does is take away DEA’s ability to go after a pharmacist, a wholesaler, manufacturer, or distributor.”
Senator Bernie Sanders (Independent-Vermont) also brought up the seeming conflict between Trump’s campaign platform of supporting lower pharmaceutical prices by importing lower-cost prescription drugs from Canada and the White House’s nomination of Dr. Gottlieb, who has publicly opposed importing Canadian drugs. Sanders was quoted as saying, “I find it amazing that Trump says something during the campaign and then appoints people who have radically different ideas.”
Sanders took to Twitter to demonstrate a pattern of conflicts between Trump’s campaign promises and his nominees. Others have similarly questioned Trump’s appointments of Seema Verma as administrator of the Centers for Medicare and Medicaid Services and of Dr. Tom Price as Secretary of Health and Human Services. Both have been criticized for either making investments in health care companies or for being too close to the industries they have been appointed to regulate.
Gottlieb, who worked as an FDA deputy for a time under the presidency of George W. Bush, had to recuse himself from discussions of the avian flu vaccine after it was learned he had been a paid consult for vaccine manufacturers Roche and Sanofi. Nonetheless, the New York Times, reporting on the April 5 hearing, stated the Gottlieb “appeared to be headed for confirmation unless some damaging new information turns up.”
At the hearing, Gottlieb told Congress he would be “an absolutely objective regulatory watchdog” and called the opioid epidemic “a public health emergency, a public health crisis.” He declined to comment on Trump’s plan for federal hiring freeze, which critics are concerned conflicts with a new law authorizing the FDA to hire additional scientists to improve the safety of the drug and medical device review process.