Later this afternoon the Senate will vote to confirm Scott Gottlieb as the next U.S. Food and Drug Administration (FDA) commissioner. What does this mean for scientists and science-based policymaking at the FDA? His conflicts of interest are certainly an indication that the pharmaceutical industry will benefit more from his tenure than Americans’ health.
Gottlieb is a medical doctor with extensive ties to the pharmaceutical industry, including GlaxoSmithKline and Vertex Pharmaceuticals, taking $400,000 from drug and medical device companies in consulting and speaking fees between 2013 and 2015. He has not been shy in his criticism of what he calls FDA’s “cumbersome” drug approval process, and has recommended fast-tracking approval by using surrogate markers to gauge the effectiveness of new products. Surrogate markers would allow drug companies to conduct shorter studies with smaller sample sizes. A win for drug companies, but not necessarily for public health.
Many have called President Trump’s band of department heads the “corporate cabinet” because of the astounding degree of conflicts the individuals have with regulated entities, i.e. corporations. They are the epitome of foxes guarding America’s henhouses. Despite the fact that Trump campaigned upon promises to “drain the swamp” of former lobbyists in federal government, his actions during his first several months in office have not supported his pledge. Gottlieb has mentioned that he would recuse himself from decisions within the next year having to do with all 20 companies with which he has had a financial relationship. But after one year, all bets are off. Scott Gottlieb will be making policy decisions that directly impact companies with which he has had financial ties and personal relationships. Judging from his past statements on the FDA regulatory process as well as his work history, it doesn’t seem likely that he will be making completely science-based, objective decisions that weigh the health of Americans over the profits of drug companies.
What FDA scientists think about industry influence on the agency’s mission
Back in 2015, we surveyed several agencies, including the FDA, to find out how scientific integrity was faring under the policies instituted by the Obama administration. Forty-five percent and 33 percent of surveyed FDA scientists said that the level of consideration of political interests and business interests, respectively, at the agency was “too high.” One-third of respondents agreed that the FDA has been harmed by agency practices that defer to business interests.
When we asked how the mission of the FDA and the integrity of the scientific work produced by the FDA could best be improved, several themes arose. In addition to calls for increased agency funding and staffing, additional transparency, and more opportunities for scientists to attend conferences and collaborate with other scientists, survey respondents also called for less industry influence on science and policy decisions at the FDA. I urge Scott Gottlieb to take a look at some of the following concerns from real FDA scientists about the relationship between FDA and the pharmaceutical industry.
- Industry should have fewer opportunities to interfere with science process, not more:
- “Minimize the links between the Agency and the industry it regulates—primarily those that provide money from industry to the FDA and those that lead to future employment opportunities for FDA management.”
- “Stop having industry make a call to FDA and “put pressure” on an approval.”
- User fee arrangements have pressured the FDA to cater to industry and approve more drugs:
- “The mission of those Centers which are funded in large part by user fees has been altered, in my opinion, to cater to industry and whatever their concerns are at the moment. There is an inherent conflict of interest in being paid/funded by the industries we are supposed to regulate. That said, FDA has made great strides in meeting MDUFA (user fee regulations) reduced review timelines and increasing the number of device approvals. However, my concern is that some devices that may not have met their efficacy endpoints—e.g., they don’t work—will get approved/cleared anyway because they don’t pose any safety concerns. I believe we should follow our “science”-based evidence rather than compromise to keep industry happy.”
- “During the Bush years, our mission shifted from making sure drugs were safe and effective to making sure they were ‘safe, effective and approved in a timely manner.’ (That made no sense because if a drug is safe and effective, it *will* be approved). We need to institute safeguards so that business interests don’t influence decisions, depending on who is in the White House.”
- “NOT taking money from industry via PDUFA funds and getting all FDA appropriations from the government and not making all the PDUFA quid pro quo to satisfy industry for its money. This PDUFA arrangement/program keeps increasing all kinds of arrangements to benefit industry.”
- “I think that ADUFA has changed the working environment and there is a more pressure to approve drugs. Sponsors are more vocal in their complaints, whether or not they are justified.”
- The revolving door at the FDA is dangerous:
- “By stopping the revolving door of industry people who are brought into high level positions, wreak havoc during their tenure, then return to the industry from which they came.”
- “Although it obviously would be difficult to achieve due to pressure from politicians and businessmen, it would be better if high level (and other) FDA employees were not part of the revolving door process in which people come from the regulated industry (or law firms representing the regulated industry), work for the FDA and then return to high paid jobs in the private sector.”
- “I don’t think we should be filling leadership roles at the agency with ex-pharmaceutical company executive. I don’t think the fear of being sued by pharmaceutical companies should limit our regulatory authority.”
While agency scientists seem uncomfortable with the level of corporate involvement in regulations, industry is likely feeling pretty comfortable with the current regulatory landscape for food and drugs. Tom Price, who has invested in and made policy decisions in line with drug manufacturers while a member of Congress, is now the head of the US Department of Health and Human Services. In late April, U.S. Surgeon General Vivek Murthy was removed by the Trump Administration. Murthy had issued a 2016 report on e-cigarettes concluding that use among children and teenagers is a “major public health concern.” Shortly after he left office, the FDA announced it would be delaying enforcement of e-cigarette regulations that were finalized last year.
Last week, a leaked memo revealed that the Trump administration is planning on slashing funding to the White House Office of National Drug Control Policy by 95 percent during a time when heroin and prescription painkiller use in this country and related preventable deaths are spiraling out of control. And as obesity and related health consequences continue to rise, Mr. Gottlieb has already indicated that he would be open to delaying implementation of changes to the nutrition facts label including an added sugar line, as the food industry has requested. It seems like any regulation that inhibits the ability of drug or food manufacturers to approve and introduce an endless stream of new drugs and food additives will be unpopular under this administration.
A plea from FDA scientists and the public
Mr. Gottlieb: I implore you to stick to the commitment you made during your confirmation hearing to make decisions based on safety and efficacy and to be “guided by the science,” “guided by the expertise of the career staff,” and “guided by impartiality and what’s good for patients as a physician.” As FDA commissioner you must remember that the FDA is beholden to the people, not the pharmaceutical or food industries.
And hey, your new employees agree. To protect scientific integrity at the FDA, surveyed scientists urge the agency (that’s you now!) to “recognize that FDA’s customers are the general public; the sponsoring companies submitting new treatments are not.” And to remember that “clear acceptance that our ‘customer’ is the American people, and our mission is protecting and promoting public heath. Our customers are NOT industry, and performance metrics should not be geared to appeasing industry stakeholders at the expense of the public.” Let the expertise of those career scientists be your guide!