RSSScott Gottlieb's nomination as the next FDA commissioner is garnering support from industry, but it's generating some opposition from other quarters.
A few lawmakers and Public Citizen, a watchdog group, were among the first to express concern about the nomination, citing Gottlieb's connections to industry and his "deregulatory approach."
"Gottlieb is entangled in an unprecedented web of big pharma ties," said Michael Carome, director of Public Citizen's Health Research Group. He noted that Gottlieb – a physician, resident fellow at the American Enterprise Institute, venture partner at New Enterprise Associates and a former FDA official – has recently served on the board of five drug companies, including Glaxosmithkline plc.
Between 2013 and 2015, Gottlieb received at least $413,000 from biopharma and medical device companies, mostly for consulting and speaking fees, Carome said.
Similar concerns were raised last year when a few senators held up confirmation of cardiologist Robert Califf, who was nominated to the post by President Barack Obama. (See Medical Device Daily, Jan. 27, 2016.)
Acknowledging the industry connections of previous FDA commissioners, Carome said Gottlieb's confirmation "would 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."
Although not as negative as Carome about Gottlieb's links to industry, Sen. Patty Murray (D-Wash.) voiced some reservations. She said she plans "to closely review Dr. Gottlieb's long career in the health sector, including his work with multiple pharmaceutical companies, medical device companies and investment firms, to determine whether financial entanglements or conflicts of interest could impact his decision-making." Murray is the ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, which is likely to hold the first hearing in Gottlieb's confirmation process.
EXPERIENCE A PLUS OF MINUS?
As with Califf, trade organizations view Gottlieb's familiarity with the health care industry as a plus.
"His extensive experience as a physician and breadth of health care knowledge will help ensure the FDA continues to play a vital role in protecting public health and innovation," said Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America.
Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said Gottlieb's medical credentials, "combined with years of service in leadership roles at both CMS and FDA, make him a strong choice to lead this agency."
While at the FDA, Gottlieb spoke out about the need for experience and expertise when he pushed back against proposed legislation to rid advisory committees of all potential conflicts of interests.
"It would be a significant step backward if our primary criterion for selecting members to our committees becomes their lack of private sector work if we exclude people for deep experience rather than embrace them for it," he said at the time.
Although FDA commissioners need to have expertise in the health care field, previous industry ties can sometimes get in the way of their duties. When Gottlieb served as the FDA deputy commissioner for medical and scientific affairs, he had to be recused from several key agency meetings and decisions because of his industry connections, Carome said, adding that more recusals could be expected if Gottlieb were to be confirmed as commissioner.
Even more concerning to the critics is what Carome called Gottlieb's "dangerous deregulatory approaches" to the review of new therapies.
"In exchange for getting medications to the market faster, Gottlieb is willing to accept a greater degree of uncertainty about safety and effectiveness at the time of approval. He also has favored looser restrictions on off-label promotion," Carome said.
Gottlieb has been vocal about undue FDA restraints on sponsors' truthful off-label communications with doctors. He also has expressed skepticism about comparative-effectiveness research using retrospective studies that wouldn't pass the FDA's evidentiary bar in the approval process. But he's also pushed for the agency to make better use of modern information tools in monitoring the safety of new therapies.
When the growing number of drug shortages captured headlines in 2011, Gottlieb pointed a finger at the price controls created under the Medicare Modernization Act, coupled with the disparities of the FDA's manufacturing inspections.
That same year, he spoke on drug pricing at a hearing before the Senate Committee on Aging, cautioning against the use of mandatory Medicare rebates. He described rebates as controls that distort drug prices by raising the prices to cover the rebate. He also urged the committee to consider how future policies would affect investment in the biotech sector, given that investment drives innovation.
SCRUTINY TO COME
As the confirmation process moves forward, Gottlieb's stance on such issues will be scrutinized.
"I have initial concerns about how his views would impact our ability to maintain the gold standard of FDA approval," Murray said. "I have also long fought to ensure that medical expertise – not ideology – governs FDA decision-making on critical products, including Plan B, and would find it unacceptable if a nominee for FDA commissioner showed any sign of failing to uphold that basic standard."
Rep. Rosa DeLauro (D-Conn.) – who, as a member of the House, won't vote on Gottlieb's confirmation – is concerned that Gottlieb would carry out President Donald Trump's plans to reduce the regulatory burden.
Gottlieb's nomination sends a message that Trump "is committed to rolling back regulations and opening the floodgates to potentially dangerous drugs and medical devices," DeLauro said.
With Gottlieb at the helm, Trump would see the FDA as the "go-to agency for his plan to repeal two existing regulations for every new regulation proposed," she added.
Despite her fears, DeLauro indicated that Gottlieb's confirmation is a done deal, so she offered him some advice: "Now that Mr. Gottlieb will oversee the FDA, he must remove himself from any pharmaceutical industry ties – of which he has many – and work for the American people, not for the drug and medical device industries."
For his part, HELP Committee Chairman Lamar Alexander (R-Tenn.) noted that "it's critical to have the right person in charge of the FDA" and spoke of Gottlieb's "impressive qualifications helping American patients as both a physician and in his previous roles at the FDA."
During the committee's confirmation hearing, Gottlieb will be asked about his plans to implement the 21st Century Cures Act that was passed in December and to "work with Congress to bring safe and effective drugs and medical devices to patients more quickly and to protect the nation's food supply," Alexander said.