WASHINGTON — FDA Commissioner Scott Gottlieb, MD, announced Tuesday that he would leave the post in a month, surprising many and pleasing few. And a House appropriations subcommittee held the first hearing to discuss earmarked funding for gun violence research.
FDA Chief’s Resignation Greeted Mostly by Surprise, Praise
Reactions to Tuesday’s resignation of FDA Commissioner Scott Gottlieb, MD, were mostly characterized by surprise as well as praise for the job he has done.
Gottlieb’s official reason for leaving was that he wanted to spend more time with his family, something he elaborated on Wednesday in a video interview with The Hill. “I was commuting from Westport, Connecticut with three young kids. I would get home late Friday night, have dinner with my wife, see my kids on Saturday, work all day Sunday, and be back on the train Sunday night. Two years of that got hard; it got hard on the family.”
“If I had to do it over again, I think I would have moved them down here from the outset, but I didn’t, and it’s too late to do that now,” he added.
“I was totally shocked; we were definitely not expecting this,” said Antonio Ciaccia, cofounder and researcher at 46Brooklyn Research, a non-profit drug pricing research firm in Columbus, Ohio. “It seemed like he was still kind of mid-stride. You’d think he’d be finishing things up, putting a bow on something, but he’s right in the middle on a lot of big things, so to see him announce he was stepping away was very surprising.”
Esketamine Approved for Treatment-Resistant Depression
The FDA approved esketamine (Spravato) nasal spray, to be used with an oral antidepressant, for treatment-resistant depression late Tuesday.
Esketamine is the S-enantiomer of ketamine, an FDA-approved anesthetic and a street drug called Special K which is known for its dissociative and hallucinogenic effects. Agency approval came with a Risk Evaluation and Mitigation Strategy (REMS) to restrict esketamine to certified treatment centers where patients are monitored for 2 hours, prohibit it from being dispensed directly to patients, and enroll patients in a registry.
Esketamine has the potential to be a game-changer in treating depression, said Walter Dunn, MD, PhD, of the University of California, Los Angeles, and a member of the FDA’s Psychopharmacologic Drugs Advisory Committee.
“The approval of esketamine is a groundbreaking advance in the treatment of depression, given its novel mechanism of action and time frame at which it produces clinically meaningful improvements,” he told MedPage Today.
House Panel Debates Gun Violence Research Funding
House members and expert witnesses at a Thursday hearing tussled over whether federal dollars are needed to study gun violence.
The NIH had a 3-year initiative aimed at exploring the “epidemic of gun violence,” but the agency chose not to extend it, said Rosa DeLauro (D-Conn.), who chairs the House Labor, HHS, and Education Appropriations Subcommittee. Now, she and her Democratic colleagues want those funds restored, and they want to target funding for the CDC to support additional research.
Gun violence is a “public health emergency” killing more Americans since 1968 than all of the nations’ wars combined, she said.
“As our witnesses will attest, the 20-year gap in CDC research has left a vast void in our understanding of how to prevent gun violence. CDC is the nation’s public health agency, and therefore it must be involved,” DeLauro said.
One witness and several Republicans on the subcommittee, including Ranking Member Tom Cole (R-Okla.), questioned the need to dedicate federal dollars to either agency, arguing that researchers themselves should determine how funding is spent.
Physician-Senators Square Off on Vaccine Mandates
Two Republican senators, both physicians, clashed Tuesday over whether the government should make vaccinations mandatory.
When Sen. (and ophthalmologist) Rand Paul, MD (R-Ky.), known for his libertarian views, said some vaccine mandates had “run amok,” that drew the attention of Sen. (and gastroenterologist) Bill Cassidy, MD (R-La.).
“If you are such a believer in liberty that you do not wish to be vaccinated, then there should be a consequence and that is that you cannot infect other people,” Cassidy said, implying that unvaccinated children shouldn’t be allowed in schools.
The venue was a Health, Education, Labor, and Pensions (HELP) Committee hearing meant to gain insight from stakeholders regarding what Congress can do to boost vaccination rates and reduce “vaccine hesitancy.”
Changes Afoot for Kidney Disease Payment in Medicare
For Health and Human Services Secretary Alex Azar, Monday’s announcement on how his agency is changing financial incentives for treating kidney disease was in part a personal affair.
“What kidney patients endure is grueling,” Azar said at the annual Kidney Patient Summit, sponsored by the National Kidney Foundation. “I know this firsthand, because my dad suffered from end-stage renal disease [ESRD]. Like others with the disease, my dad initially had to go to dialysis three or four times a week. I saw how draining it is.”
“My dad’s situation did improve,” he continued. “First, we figured out that he could receive peritoneal dialysis, allowing him to be dialyzed at night. This was a revolutionary change in his lifestyle. Then, we were blessed enough that he was offered a kidney transplant from a kind and generous living donor.”
And while Azar’s father was lucky, “too many Americans don’t shift to more convenient dialysis options, and too many Americans never get a chance at a kidney transplant,” Azar said. “But with better policies, we can make these outcomes possible for many more Americans.”
On Monday, the Physician-focused Payment Model Technical Advisory Committee meets to discuss and vote on two new payment models.
On Wednesday, the House Committee on Appropriations will examine the FY 2020 budget request for the Department of Health and Human Services.
On Thursday, the Senate Finance Committee will also discuss the HHS FY 2020 budget request.
And the Senate Appropriations Committee will address the Ebola outbreak in the Democratic Republic of the Congo.
On Friday, the Medicare Payment Advisory Commission will release its March report to Congress.