The Food and Drug Administration’s approach to consumer protection faces a potential turning point this week when a Senate committee takes up President Trump’s nomination of Scott Gottlieb to head the agency.
Trump has called for slashing FDA restraints on pharmaceuticals, and with Gottlieb’s appointment he would entrust the task to a doctor and former FDA official who has been immersed in the pharmaceutical industry.
The FDA oversees a vast swath of the US economy, from food, cosmetics, and tobacco to medical devices. One of its main missions is making sure that prescription medicines sold to the public are safe and effective.
As the Project On Government Oversight has reported, the FDA’s independence as a consumer watchdog is compromised by the fact that the agency is addicted to drug money. The FDA gets much of its funding through so-called “user fees” paid by pharmaceutical and medical device companies, and the money comes with strings attached, giving industry extraordinary leverage over its federal overseer.
Now, Trump is proposing to double down on that arrangement. In a recently released “Budget Blueprint,” Trump has proposed increasing the FDA’s dependence on user fees.
Meanwhile, in Gottlieb, he has chosen a potential FDA commissioner whose financial disclosures list line after line of payments from drug and biotech companies.
Gottlieb has been on the boards of companies such as Tolero Pharmaceuticals and Daichii Sankyo U.S. He’s been a consultant to Bristol-Myers Squibb and Vertex Pharmaceuticals. He’s served as acting chief executive of Cell BioTherapy and acting co-chief of Tivorsan Pharmaceuticals. He’s served on an investment board for GlaxoSmithKline. He’s collected speaking fees from the likes of Merck, Biogen, and Johnson & Johnson.
According to the form filed with the Office of Government Ethics, Mallinckrodt Pharmaceuticals paid him a speaking honorarium of $22,500.
Mallinckrodt is a major producer of oxycodone, an addictive drug at the center of an opioid abuse epidemic.
The list goes on.
Under a federal ethics agreement, Gottlieb has pledged to recuse himself for one year from particular matters involving certain specific companies with which he has had connections. However, such restrictions could be waived, and in any event he would be free to shape overall policies that affect those companies.
Gottlieb is scheduled to appear before the Senate Committee on Health, Education, Labor & Pensions, also known as the HELP Committee, for a confirmation hearing Wednesday. The Committee oversees the FDA.
Coincidentally, the same Committee is holding a hearing Tuesday on plans to reauthorize for another five years the industry-paid user fees on which the FDA depends. Under federal law, the FDA was required to negotiate with industry to keep the fees coming. Congress must now review the deal the agency struck with the drug lobby; that agreement calls for the FDA to explore alternative ways of assessing drugs that some critics fear could be less rigorous than the data from controlled clinical trials on which the FDA has long based decisions.
To be sure, Gottlieb and the FDA aren’t the only ones who have been collecting drug money. Pharmaceutical firms have been among the top contributors to members of the HELP Committee, including Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA), according to the Center for Responsive Politics.
In a statement last week, Murray expressed skepticism about Gottlieb.
“President Trump promised to ‘drain the swamp,’ and as it stands, Mr. Gottlieb’s ties to the companies and industries he will regulate do exactly the opposite,” she said.
Alexander declared him “well-qualified to lead the FDA.”
The FDA and the person who would lead it must balance competing demands: swiftly approving desperately needed drugs, but keeping bad ones off the market.
To shed light on how Gottlieb would balance those demands, the Project On Government Oversight suggests that Senators ask him these bellwether questions:
- Like many politicians, President Trump has complained about the high cost of prescription drugs. He has also stated that he wants to cut regulations and speed drug approvals. What would you do to make sure that the drugs the FDA approves are both safe and effective, so that patients, health insurers, and the federal government don’t waste money on harmful or useless products?
- In a potential counter-weight to industry’s influence over the agency, the FDA is required by law to consult with consumer and patient advocacy groups. However, the FDA has met that requirement in large part by consulting groups that are backed by the drug industry and populated with industry personnel. What would you do to seek out independent patient and consumer representatives? How would you avoid giving industry another inside track through the guise of patient groups? And would you require the groups the FDA consults to disclose any relationships with industry?
- It’s one thing to fund the FDA with user fees paid by industry. It’s another thing to require the FDA to negotiate with industry over how it spends the money and does its job. That makes the regulator beholden to the regulated. If Congress and the president are determined to continue funding the FDA with user fees, why insist that the money come with strings attached, and why allow industry to pull the strings? Why not cut the strings and eliminate the negotiating requirement?
- Both the latest deal the FDA cut with the pharmaceutical industry over user fees and the 21st Century Cures Act passed by Congress last year could set the FDA on a course to base drug approval decisions on so-called “Real World Evidence”—alternatives to scientific data collected in controlled clinical trials. What would you do to make sure that “real world evidence” is more than anecdotal, and that it can’t be manipulated by industry to get drugs approved?
- The 21st Century Cures Act would allow the FDA to approve new uses of old drugs based only on “data summaries” submitted by drug makers. As FDA commissioner, would you require FDA reviewers to look beyond those summaries and study the underlying data? How would you prevent drug makers from cherry-picking the data included in their summaries and duping the FDA into concluding that the drugs are better than they really are?
- Drug companies love to get products approved based on “surrogate endpoints,” which are proxies for the medical outcomes the drugs ostensibly promote. For example, if a drug is meant to prevent sudden death from heart attacks, a surrogate endpoint might be lowering cholesterol. But, as POGO has reported, surrogate endpoints are not always good predictors of a drug’s effectiveness. What would you do to make sure any surrogate endpoints the FDA accepts are more than just pretexts to approve the unproven?
- In an address to Congress, President Trump said that a “slow and burdensome approval process at the Food and Drug Administration keeps too many advances . . . from reaching those in need.” Do you agree? If not, why not? If so, specifically how do you see the FDA approval process as slow and burdensome?
- Can you point to any drugs or medical devices that the FDA approved but should not have? If so, why do you think that happened, and how would you prevent it from happening again?
- If you are confirmed, what do you anticipate doing professionally after you leave the FDA? For example, what work, if any, will you do in industries overseen by the FDA? What if anything would you rule out doing in those areas?