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FDA Chief: COVID Vaccine in Pregnancy Should Be Personal Choice
U.S. News and World Report reported:
Federal health officials have pulled back a key recommendation that pregnant women get the COVID-19 vaccine — causing sharp criticism from doctors and other experts.
The announcement came Tuesday from Health and Human Services Secretary Robert F. Kennedy Jr., who said the government will no longer recommend COVID-19 shots for healthy children or pregnant women.
Dr. Marty Makary, head of the U.S. Food and Drug Administration (FDA), said Wednesday that the decision should be made between a pregnant woman and her doctor. “The data on the COVID vaccine booster in pregnant women is a mixed set of data,” Makary said in an interview. “Now, I think the decision should be between a doctor and a pregnant woman.”
The U.S. Centers for Disease Control and Prevention (CDC) usually relies on a panel of vaccine experts to review studies and make public health recommendations. This process was skipped in making the COVID-19 recommendation.
The CDC, which currently has no director, still hasn’t updated its website to reflect the change. Its advice plays a major role in insurance coverage. If the CDC no longer recommends a vaccine, many patients may be unable to get it for free.
Senator Grills Makary Over FDA’s Ability to Regulate Drug Ads After OPDP Cuts
In the wake of sweeping cuts at the U.S. Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP), Sen. Dick Durbin, D-Ill., is questioning how effectively the agency can continue to regulate pharmaceutical advertisements.
The lawmaker sent a letter to FDA Commissioner Marty Makary, M.D., this week requesting information about the regulator’s “operational capacity” to carry out that work, citing both the staff cuts and Makary’s own “recent public statements expressing an interest in “mak[ing] sure that the information being presented … in those ads … is a complete picture.”
The layoffs in particular “raise major questions about whether FDA has the personnel, expertise, and capacity to fulfill its mission to regulate prescription drug advertisements,” Durbin wrote. Late last month, the two highest-ranking OPDP leaders reportedly stepped down, following far-reaching layoffs earlier in April that completely cleared out the office’s Division of Promotion Policy, Research and Operations, among other impacted teams.
FDA Accepts Application for Oral Version of Wegovy
The U.S. Food and Drug Administration (FDA) recently accepted a new drug application for oral semaglutide. If approved, it would be the first oral glucagon-like peptide-1 (GLP-1) receptor agonist authorized for long-term weight management. The 25-mg semaglutide pill would be marketed as Wegovy, the same name used for Novo Nordisk’s FDA-approved 2.4-mg semaglutide injection.
The pharmaceutical company announced the submission following the results of a phase 3 randomized clinical trial, which compared the oral treatment with a placebo in about 300 adults with obesity or overweight and at least 1 comorbidity. The nearly 16-month trial included a 3-month dose escalation and a 7-week off-treatment follow-up period.
The FDA decision is expected later this year, according to Novo Nordisk.
A New Covid Variant Could Drive up Summer Cases: Here’s What You Should Know
A new COVID-19 variant that’s gaining momentum globally has landed in the U.S.
The World Health Organization (WHO) announced last week that it was monitoring the variant, NB.1.8.1, following a rise in cases in several parts of the world, including Europe, Southeast Asia and North and South America.
The variant appears to be more transmissible than the dominant strain worldwide, LP.8.1, meaning it has the potential to drive up cases this summer. But it does not seem to be much better than LP.8.1 at evading protection from vaccines or a prior infection. And the WHO has found no evidence that it leads to more severe illness, so the agency has determined that it doesn’t pose an added health risk.
“It’s an important one to track, but it doesn’t show any signs so far of being able to drive a large surge in Covid-19 cases — at least in the U.S.,” said Andrew Pekosz, a virologist at Johns Hopkins Bloomberg School of Public Health.
GSK-Licensed Antibiotic Meets Goal in Late-Stage Study
With the success of the study, GSK is now hoping to offer doctors yet another new weapon to fight the surge in antimicrobial resistance. In March, the British drugmaker won the U.S. Food and Drug Administration (FDA) approval for a new kind of oral antibiotic now sold as Blujepa for people with certain uncomplicated urinary tract infections.
GSK bought most of the rights to tebipenem in 2022 from Spero Therapeutics, as the Massachusetts biotech was reeling from an FDA rejection of the medicine. At the time, GSK made an investment in Spero and paid the company $66 million upfront. The agreement included the possibility of royalties for Spero plus as much as $525 million in payments for reaching certain regulatory and sales milestones.
Spero long thought it had a winning antibiotic on its hands to help treat drug-resistant bacterial infections. A Phase 3 trial in 2020 looked successful and the FDA accepted the company’s marketing application in January 2022. But then the FDA challenged the company’s study analysis and ended up rejecting the medicine in June 2022. Almost all of Spero’s market value was wiped out.
CVS and Express Scripts Sued to Block a New Law Restricting Drug Middlemen
CVS and Cigna-owned Express Scripts filed lawsuits Thursday to block an Arkansas law that tries to curb the power of pharmacy benefit managers (PBMs) in the state.
PBMs, also known as drug middlemen, are third-party administrators of prescription drug plans for health insurers. They negotiate with pharmaceutical companies over how much a health plan will pay for a drug and set the out-of-pocket costs for patients.
Arkansas Gov. Sarah Huckabee Sanders signed a law last month that banned PBMs from owning and operating pharmacies in the state, saying at the time that they “have taken advantage of lax regulations to abuse customers.”
