fda
The good life
Lizzy Lawrence gives a rundown of former FDA Commissioner Marty Makary’s tumultuous tenure, personnel drama, and political pressures.
Before boarding a flight to China, President Trump said a few words about Makary's departure.
“He’s going to go on and he’s going to lead a good life,” Trump said. “He was having some difficulty. He’s a great doctor. He’s going to go on and do well.”
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“Everybody wants that job.”
That’s the last line from Trump's full quote about the FDA commissioner post.
Even if true, replacing Makary might take until after the midterms given the backup of nominees for high level health positions. The administration now needs to get Senate confirmation for a CDC director, a surgeon general, and an FDA commissioner.
All three must go through Cassidy’s health committee.
And there are vacancies and temporary acting directors strewn about the FDA. FDA acting drug center Director Tracy Beth Høeg was closely allied with Makary, making her fate uncertain. The acting head of the biologics center was the deputy to Vinay Prasad, who’s already left. And the food center is run by Kyle Diamantas, who is now the acting head of the FDA.
Check out this organizational chart for the FDA’s biologics center alone.
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The Trump administration is moving quickly to identify the next FDA leader, with an eye for someone who can rebuild trust with agency staff, focus on the agency’s food policy, and continue to drive drug-approval reforms, Daniel and Lizzy report.
It could be difficult to find someone who can earn the trust of FDA employees amid plummeting morale. But administration leaders hope to conduct the search over “the next several weeks,” according to an official with knowledge of the process.
Read more about the reactions from FDA employees to Makary’s resignation.
hospitals
Federal grand jury subpoenas for gender-affirming care
Several hospitals have received federal grand jury subpoenas over the provision of gender-affirming care to minors, Theresa Gaffney reports, suggesting the Department of Justice has begun a criminal investigation.
So far, Trump administration legal challenges to gender-affirming care have mostly not gone well.
But the legal actions have still had an impact. Dozens of hospitals around the country have paused or ended transgender services, citing legal pressures.
Read more.
hospice
Hospice moratorium
For the next six months, no more hospice and home health agency providers can apply to Medicare, O. Rose Broderick reports.
The pause is the latest effort from the Trump administration to fight fraud, waste, and abuse in federal health care spending. In January, the administration threatened a two-year licensing freeze for new providers of home and community-based services in Minnesota, and it instituted a similar nationwide halt on durable medical equipment suppliers in February.
The moratorium will not stop Medicare beneficiaries from enrolling in hospice care. Read more.
drug pricing
Update on Medicare drug price negotiation litigation
Supreme Court justices are scheduled to meet in private today to consider whether to take up the six pending drugmaker petitions challenging the Medicare drug price negotiation program.
It’s a surprising request, according to Andrew Twinamatsiko, director of the Georgetown University Center for Health Policy and the Law, given that drugmakers have lost their appeals in the lower courts. There was one dissenting opinion in the Bristol Myers Squibb and AstraZeneca cases, which were decided jointly, and the Fifth Circuit ruled in favor of industry on a procedural argument. Drugmakers have latched onto those two developments in their request for the Supreme Court to intervene.
There are two remaining cases pending before the Fifth and D.C. circuit courts.
The six petitions come from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Novartis, and Novo Nordisk.
“The Court has shown little eagerness to take these up,” Twinamatsiko said.
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