Scott Gottlieb, M.D., might be a potential replacement for former HHS secretary Tom Price, but the FDA commissioner says he'd rather stay put—and pharma may prefer the same thing, given industry response to changes he's made since taking the helm.
Gottlieb downplayed the possibility of taking up the top HHS post in a Reuters interview, saying he believes he can be "most effective" at the FDA. The commissioner said the drug agency needs "continuity of leadership" and that he's witnessed a change at the top that hurt operations.
Gottlieb declined to say whether he's discussed the HHS job with the Trump Administration, according to the news service. On Tuesday, President Trump named Eric Hargan as acting HHS head after Price resigned late last month. Hargan was just sworn in last week as deputy secretary. CMS chief Seema Verma and Louisiana Gov. Bobby Jindal are other candidates for the HHS job, according to The Hill.
Before his nomination, Gottlieb was the drug industry's favored pick by a wide margin. During a recent discussion at FierceBiotech's Drug Development Forum in Boston, three industry executives agreed that the FDA had been taking steps to facilitate faster approvals prior to Gottlieb's arrival, and that he's the right person to build on that progress.
Martha Carter, chief regulatory officer of Albireo Pharma, said Gottlieb is “one of the better choices because he actually worked at the FDA before."
"He understands how it really works," she continued. "He has sensibility about what the industry is trying to do, and he isn’t coming in to systematically dismantle it.”
Carter isn't alone in her assessment. Many executives have favored Gottlieb's appointment, with a Mizuho Securities poll ahead of the nomination finding he was far and away biopharma's top candidate.
Under Gottlieb, the FDA has been aggressive on the opioid epidemic and on drug prices, among other issues. The agency pushed Endo International to remove its Opana ER painkiller from the market and pledged to take another look at approved opioid drugs. The FDA also said it'd work with PBMs and payers to limit dispensing.
While the FDA doesn't regulate drug prices, Gottlieb and the agency have won praise with their steps on that issue. In May, Gottlieb unveiled several strategies the FDA would take to lower prices, including changes to approval review times for some meds. He said the FDA would publish and regularly update a list of medications that are off patent and have no competition, work to shorten generic approval reviews and seek to “curtail gaming” of regulations by the industry that allows companies to extend patent monopolies.
Off-patent meds that face no generic competition are subject to high price hikes that drive up drug costs overall, and Gottlieb said a list of those drugs could entice competition. Valeant's Isuprel, which has been at the center of its own pricing controversy, now faces a new generic competitor.
More recently, Gottlieb took aim at "complex generic drugs" that are hard to copy because they are protein-based or incorporate a delivery device. In that effort, the FDA published new draft guidance aimed at helping companies develop and license complex generics. Mylan won a high-stakes copycat approval of Teva's multiple sclerosis drug Copaxone the next day.
And Gottlieb talked up another effort at the agency last month: the FDA is working to "modernize" its review process as a wave of cell and gene therapy applications hit the agency. Novartis won a groundbreaking approval over the summer for the first CAR-T cancer drug, Kymriah.
So far this year, the drug agency has approved 35 new drugs—versus 22 last year—and a record number of generics, according to Regulatory Focus.