Ousted Vaccine Regulator Vinay Prasad Is Back At FDA
It is not clear whether Prasad will still serve as the agency’s chief medical and scientific officer, Stat reports. Meanwhile, Center for Drug Evaluation and Research staff grill top drug regulator George Tidmarsh about the challenges they face.
Stat:
Vinay Prasad Returns To The FDA, Weeks After His Ouster
Vinay Prasad is returning to the Food and Drug Administration to resume his role overseeing vaccine, gene therapy, and blood product regulation. “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” Health and Human Services spokesman Andrew Nixon told STAT on Saturday. (Lawrence, 8/9)
Stat:
'Struggling' FDA Employees Ask About Unusual Meetings And Staffing
Top drug regulator George Tidmarsh assured Food and Drug Administration staff this week that he and other leaders are trying to bring operations back to normal. “I know that I’m coming in here at a challenging time,” Tidmarsh said at a town hall meeting on Friday with the Center for Drug Evaluation and Research staff. “That is not lost on me.” (Lawrence, 8/8)
In other FDA and pharmaceutical news —
Medscape:
FDA Approves Zongertinib For HER2-Mutated NSCLC
The FDA has granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.) for certain adults with unresectable or metastatic nonsquamous non-small cell lung cancer (NSCLC). Specifically, the TKI was approved for patients whose tumors harbor HER2 (ERBB2) tyrosine kinase domain-activating mutations as detected by an FDA-approved test and who have received prior systemic therapy, according to the approval notice. (Worcester, 8/8)
Reuters:
GSK's Antibiotic Gets FDA Priority Review For Oral Treatment Of Gonorrhea
British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for priority review of gepotidacin, an oral antibiotic to treat sexually transmitted uncomplicated gonorrhea. (8/11)
The Hill:
Popular Sweetener Recalled Nationwide As FDA Warns Of Label Mix-Up
A pair of sweeteners are being recalled nationwide due to a labeling mishap, according to the Food and Drug Administration (FDA). The Oregon-based company known for its sugar-free sweeteners is recalling NuNatural’s Organic Pure Stevia and Pure Monk Fruit Sweetener because 78 bottles of each – 156 in total – bear the other’s label. (Tanner, 8/8)
On vaping and food safety —
Reuters:
Exclusive: USPS Blocks Shipping Of Illicit Vapes In Boost For Big Tobacco
The U.S. Postal Service has cracked down on distributors of unregulated vapes using its services for business shipments, letters reviewed by Reuters show, in a blow to a multi-billion dollar industry that has dented Big Tobacco's sales. The letters, previously unreported, show that USPS wrote to major New York-based distributor Demand Vape, blocking it from using its services after New York City's Law Department, which represents the city's government and officials in legal matters, provided evidence that its shipments broke laws. (Rumney, 8/11)
KFF Health News:
Listen: Regulatory Rollbacks And Federal Layoffs Could Threaten America’s Food Supply
If there were an outbreak of E. coli or another foodborne pathogen, would you want to know about it? Some scientists at the Food and Drug Administration worry that looser regulations and layoffs could make it harder for people to get that news and protect themselves. KFF Health News senior correspondent Stephanie Armour explained on WAMU’s “Health Hub” on Aug. 6. how the Trump administration is reshaping America’s food safety system. (Armour, 8/11)
