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Robert F. Kennedy Jr.’s tenure atop HHS has been marked by increasing tension between career scientists and political leaders at health agencies. That tension is nearing a breaking point at the FDA, according to interviews with more than 20 current and former agency officials, as well as legal experts.
That breaking point arrived after agency scientists received an unusual inquiry in August from the leader of the center that regulates prescription medicines to learn more about leucovorin as part of Kennedy’s bid to identify autism’s root cause by September.
Experts say the push to approve leucovorin, a generic drug that’s mainly used to alleviate side effects of cancer treatment, as an autism treatment is a sign that the U.S. is headed toward a new era of drug regulation: one where political decisions lead, and evidence follows. More details from inside the agency from STAT’s Lizzy Lawrence.
biotech
Regeneron to submit gene therapy for hearing loss after positive data
Over the weekend, Regeneron published updated data on its investigational gene therapy for a type hearing loss that supports its plan to submit the treatment for approval later this year.
In a trial of 12 participants with hearing loss due to variants of the otoferlin gene, nine patients reached a level of hearing typically deemed to no longer require cochlear implants. Three patients achieved normal hearing levels, according to the results, published in the New England Journal of Medicine.
AstraZenca is second pharma company to announce drug-pricing deal with Trump
Late last Friday, President Trump announced his second “most-favored nations” deal, this time with AstraZeneca.
As was the case with his first deal, with Pfizer, the British pharma company agreed to give the U.S. Medicaid program drug prices that are in line with what it offers other major developed countries and to launch new drugs at so-called most-favored nation prices. In exchange, AstraZeneca will also get a three-year reprieve on national security-related pharmaceutical tariffs.
Though Trump officials and AstraZeneca CEO Pascal Soriot touted the agreements a way to create huge savings for patients and the government, drug pricing experts say these kinds of deals will not meaningfully affect drug costs and budgets.
AstraZeneca will also list some primary care drugs on Trump’s new direct-to-consumer site, TrumpRx.gov. In a graphic (below) shown at the White House event announcing the deal, Trump’s team said that there will be discounts up to 654% — a mathematical impossibility considering patients are not being paid to take the drugs. Meanwhile, AstraZeneca’s press release said it will offer the drugs at cash prices up to 80% lower than the list prices.
Read more.
from Politico:
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A federal program designed to free up hospital beds by allowing some seriously ill patients to be treated at home is in jeopardy because of the government shutdown. | Tony Dejak/AP Photo |
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| A SHUTDOWN CASUALTY — The government shutdown has thrown a program meant to keep patients at home into chaos.
For four years, the federal government has reimbursed more than 330 hospitals for remotely monitoring thousands of seriously ill patients at home under the initiative — until the government shutdown inadvertently put the program in jeopardy, POLITICO’s Robert King and Ruth Reader report. Now, hospitals are forced to move those patients back into facilities, filling up beds ahead of a busy flu season. “Patients who have chosen to be treated at home are facing limited space at hospitals and increased risk of falls and other negative events when they are moved to an unfamiliar environment,” said Beth Feldpush, senior vice president at America’s Essential Hospitals. “This needs to be fixed immediately.” Not enough beds: CMS created the Acute Hospital Care at Home program in 2020 to help hospitals struggling with major capacity issues monitor patients who are medically stable in their homes. It’s led to higher satisfaction scores and generally lower mortality rates than those of similar patients in other facilities. However, the original waiver for the hospital-at-home program expired in 2023 and has been extended alongside government funding bills. The waiver expired as a result of the government shutdown, which was sparked by a separate health issue surrounding Obamacare-enhanced subsidies. Program paused: UMass Memorial Health, the largest health system in central Massachusetts, said it paused the program at its flagship UMass Memorial Medical Center. One week into the shutdown, the system saw the number of people waiting for a bed increase from around 50 to 70. “We are particularly concerned as we go into the winter, where we see a higher number of flu and [respiratory syncytial virus] and Covid cases, where hospitals typically get busier,” Memorial Health Medical Director Constantinos Michaelidis said. Delaware-based ChristianaCare scaled back its program from 15 to three over five days and has one Medicare patient remaining who had to be transferred to the hospital. The short-term and uncertain nature of funding for the program has affected whether hospitals take it up, said Jiang Li, CEO of the remote-monitoring company Vivalink. |
