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WHERE ARE THE RSV VACCINES? – The role of RSV, or respiratory syncytial virus, in driving pediatric hospitalizations so early in the cold weather virus season is drawing attention to the lack of vaccines and therapies to prevent and treat it, Lauren and Katherine report.
RSV hasn’t enjoyed the same notoriety as the flu and, more recently, Covid-19 in the public consciousness, but that could change after this year’s already historic surge in cases — and pharmaceutical options in the pipeline that could soon hit the market.
Pfizer and GSK have each released data in recent months showing promising efficacy of their vaccine candidates aimed at adults 60 and older — the other side of the population prone to the worst effects of the virus — with plans to submitted for regulatory approval this year. .
Vaccinations for children are further behind. Moderna is the only company with an infant option in an early-stage trial.
Pfizer is studying a third option: Vaccinating pregnant people so that their antibodies are transferred to their fetuses, giving their babies protection during the first months of life. The company today released key data from its latest RSV vaccine trial in that group, showing a nearly 82 percent efficacy rate against severe lower respiratory tract infections from the virus in infants up to three months of age and 69 percent efficacy in infants up to six months. month.
IT’S TUESDAY. WELCOME TO PULSE RECIPES. Have you gotten your flu shot yet?
Send tips and feedback to David Lim ([email protected] or @davidalim), Lauren Gardner ([email protected] or @Gardner_LM) or Katherine Ellen Foley ([email protected] or @katherineefoley).
TODAY IN OURS PULSE CONTROL PODCAST, Lauren talks to Alice Miranda Ollstein about how the rise in RSV cases is drawing attention to a handful of drugmakers with vaccines in the pipeline. Plus, sending Alice from Michigan where Governor Gretchen Whitmer is trying to make an economic case for abortion rights.
FDA: PROVIDING ABORTION PILL BEFORE PREGNANCY IS POTENTIALLY DANGEROUS – The FDA is concerned that health care providers who pre-prescribe drugs to induce abortions could have patients use the drugs unsupervised, an agency spokesman told POLITICO’s Ben Leonard on Friday.
“The FDA is concerned about the prior prescribing of mifepristone for this use,” said an FDA spokesman who spoke on condition of anonymity to describe the agency’s sensitive policies. “Mifepristone is not approved for the prior provision of a medical abortion.”
Abortion drugs are more tightly regulated by the FDA than other drugs, limiting how the regimen can be prescribed. However, since last December, providers, including those working in telehealth, can prescribe mifepristone via a virtual appointment and send the medication by mail.
The FDA spokesman said the agency is concerned that if patients were to receive mifepristone weeks or months after receiving a prescription, a medical professional might not be able to assess whether a pregnancy is intrauterine or ectopic or have the correct due date. pregnancy.
The stance puts the Biden administration — which has publicly vowed to do everything in its power to preserve access to abortion — at odds with some abortion providers and abortion rights activists. The FDA spokesman declined to comment on whether the agency is considering updating its prescribing restrictions.
FDA will continue to tweet – Days after Elon Musk bought Twitter, FDA Commissioner Robert Califf criticized “the kind of divisive and hateful language we’ve seen on Twitter in recent days” as unacceptable.
“I grew up in the segregated South, and our society is still struggling to move forward after some of the history I experienced firsthand. There is absolutely no place for racism or anti-Semitism in our society.” Califf tweeted Monday.
Califf said that while it would be easy for the FDA to abandon Twitter, the agency will continue to use the platform to communicate health information.
“As we like to say, ‘the potential benefits (of staying on Twitter) outweigh the risk’ at this time.” The Caliph added.
EARLY FROM REAGAN-UDALL EXPERT PANEL COMMENTS – As the Reagan-Udall Foundation undertakes its review of the FDA’s tobacco program, a number of legal, industry and public health experts are submitting written and oral comments to the expert panel on the key issues they see with Center for Tobacco Products processes and operations, Katherine reports.
Biggest Relationships So Far:
- The process of applying new tobacco products needs more transparency and flexibility.
- The FDA needs to be clear about which products are legally allowed to be sold.
- CTP staff should be able to focus on science without political interference.
Eye Emoji: Several anonymous commenters who self-identified as FDA employees said they were extremely concerned about undue pressure during the scientific review process.
“Politics is being allowed to drive science and even limit or change science-based decisions,” one staffer wrote. “There is also no strategic, logical plan to address issues in a reason-based order. We are constantly being asked to focus on fixing a leaky faucet on the Titanic as it sinks.”
The FDA rejects these characterizations: “CTP decisions are based on a scientific review of the data submitted for each product,” an FDA spokesperson said in an emailed statement.
JUDGE GRANTS STAY ON MENTOL LOGIC MARKETING DENIAL ORDERS — For now, Logic’s menthol capsules for its Logic Pro and Logic Power vaporizers — devices that received marketing authorization in March — can remain on the market thanks to a temporary stay granted by a judge at the U.S. Court of Appeals in Third Circuit, Katherine reports. .
FDA ASSEMBLIES PULSE OXIMETER ADVISORY COMMITTEE – The FDA convenes an advisory committee today to review concerns about the accuracy of pulse oximeters for people with darker skin pigmentation.
“There is increasing evidence from real-world studies suggesting that the performance of pulse oximeters may be affected by skin pigmentation,” the FDA executive summary states.
The panel of outside experts is not scheduled to vote on any questions, but is being asked by the FDA to discuss a range of questions, including whether any clinical trials show different performance in patients with darker skin, and if so, whether the experts believe it may lead to increased risk for these patients. The agency is also asking panelists to discuss whether changing the labeling for the devices could help reduce the use of inaccurate readings.
FDA: CONSIDERS ALTERNATIVES TO MRI-GUIDED BREAST BIOPSY – Providers must direct patients to have procedures at other medical facilities if MRI breast biopsy grid plates and other disposable equipment are not available due to shortages, the FDA said Monday in a letter to them.
TRACHEOSTOMY TUBES IN THE ABSENCE – Shortages of tracheostomy tubes used to help patients breathe after surgery disproportionately affect pediatric patients, the FDA said in a safety communication issued Monday.
Challenges in obtaining the raw materials used to manufacture the pipes are causing supply shortages.
“The shortage of Bivona tracheostomy tubes is more likely to affect pediatric patients because the supply of alternative tubes with similar functions may be limited,” the safety communication states. “While there are other FDA-cleared tracheostomy tubes for pediatric patients, there may not be enough available to adequately alleviate the shortage.”
TUESDAY: Pfizer holds its quarterly earnings call at 10 a.m. EDT.
Thursday: Moderna holds its earnings call at 8 a.m. EDT.
Holly Grosholz it is American Association of Clinical LaboratoriesS ‘ new director of government affairs.
The FDA issued a draft guidance to sponsors containing recommendations on how to track puberty growth and development in clinical trials involving children with rare and common diseases.
The FDA published final guidance outlining its regulatory approach to human cells, tissues, or cellular or tissue-based products.
CMS issued a final rule outlining Medicare home health payment rates for calendar year 2023. The agency also issued a final rule outlining payment rates for dialysis treatment by an end-stage renal disease facility for patients with acute kidney injury.
