The biggest obstacle to Scott Gottlieb becoming the next FDA commissioner is his success, U.S. Sen. Richard Burr (R-N.C.) noted at a Senate confirmation hearing Wednesday.

Most of the criticism leveled against Gottlieb at the hearing before the Health, Education, Labor and Pensions (HELP) Committee centered on his work with drug and device companies. Echoing comments she made when Gottlieb was nominated last month, Ranking Member Patty Murray (D-Wash.) characterized his investment and consulting ties as an “unprecedented financial entanglement” with industry. (See BioWorld Today, March 14, 2017.)

But industry ties are not unprecedented, HELP Chairman Lamar Alexander (R-Tenn.) countered. Holding up the previous commissioner, Robert Califf, as a case in point, he reminded the committee that Califf, a cardiologist and researcher with connections to nearly two dozen drug and device companies, was approved by the Senate on a vote of 89-4 after President Barack Obama nominated him to the post following the resignation of Margaret Hamburg. (See BioWorld Today, Feb. 25, 2016.)

“We had a very good experience with Dr. Califf,” Alexander said, adding that Califf’s industry experience made him a good FDA commissioner. He also noted that Califf has voiced support for Gottlieb as his successor at the FDA.

Criticism of would-be public servants because of their industry experience puts them in an odd position, Alexander said, as it’s that experience that gives them the expertise needed for the job.

One of the challenges facing the next FDA commissioner is the full implementation of the 21st Century Cures Act, which was signed into law in December. Intended to streamline drug and device development by advancing new technologies and regulatory science, the legislative package is filled with nuances. The next commissioner needs to be someone like Gottlieb who can understand those nuances, Alexander said. (See BioWorld Today, Dec. 8, 2016.)

“We’re fortunate that you do have this experience,” he told Gottlieb, who is a doctor, cancer survivor, former FDA official, resident fellow at the American Enterprise Institute and a venture partner at New Enterprise Associates. He also has served on the board of several drug companies.

Should he be confirmed, Gottlieb already has committed to stepping down from his other positions, divesting his investments in drug and device companies, and recusing himself from FDA decisions involving companies he was involved with for at least a year. He said he would continue to work with the Health and Human Services ethics office to ensure that the FDA would remain an “absolutely objective watchdog” under his guard. “I know what’s at stake here,” he added.


Gottlieb used his answers to the barrage of questions to outline his top priorities for the FDA, which he promised would be guided by the science, public health needs and the expertise of the agency’s career staff. The most immediate priority on his list is the opioid epidemic sweeping across the nation. “This is a staggering human tragedy,” he said, putting it on a level with Ebola.

Over the past 10 years, the problem has grown so large that the FDA can’t address it alone, Gottlieb said. What the agency can do is ensure that it has the framework and guidance in place to develop solutions such as nonopioid alternatives for pain. That includes a pathway to develop devices to treat pain, enabling comparisons with drugs. He also stressed the need for a path to approve generic drug-device combination naloxone products to create competition, and lower prices, for emergency treatment of opioid overdoses.

When Sen. Margaret Wood Hassan (D-N.H.) asked about the FDA’s role in educating the public about the potential for addiction with abuse-deterrent opioids, Gottlieb responded that the primary impediment to their abuse is their high price. That will change when generic versions become available, he warned.

Gottlieb’s commitment to making opioid abuse his top priority may help him sidestep an issue that temporarily stalled his predecessor’s confirmation. Sen. Edward Markey (D-Mass.) placed a hold on Califf’s nomination, demanding that the FDA get tougher on its approval of opioid products. (See BioWorld Today, Jan. 27, 2016, and Feb. 9, 2016.)

Last month, Markey opposed Gottlieb on the same grounds, saying, “We need a leader at the FDA who recognizes the dangers of these supercharged opioid painkillers, who will stand up to Big Pharma and who will reform the FDA to prevent addiction before it takes hold.”

Other priorities Gottlieb noted during the hearing are increasing generic and biosimilar competition as an answer to high drug prices and ensuring the FDA has the staffing and resources it needs to fulfill its mission across all of its centers. Citing the aging of the agency’s workforce, Gottlieb said the FDA will lose a significant portion of its staff over a short period of time in the near future. That will result in a loss of experience and institutional memory. The next commissioner must prepare for that loss, he said.

The committee’s next step is a markup and vote on Gottlieb’s confirmation. Since the Senate will break for a state work period from April 10-21, Alexander said it would be a few weeks before that session can be scheduled.