REVIEW OF MPOX, COVID VACCINES CONTINUES — Today, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices kicks off a three-day meeting to discuss a variety of vaccinations. This meeting is one of the group’s regularly scheduled discussions, which typically occur three times a year, and comes with a hefty agenda, including mpox, respiratory syncytial disease and Covid-19 immunizations.
Today, advisers will consider the latest data on the safety and efficacy of mpox vaccinations, updates on the flu season and vaccination and pneumococcal vaccines. Tomorrow, they will hear presentations on meningococcal, dengue, chikungunya and polio vaccines, as well as late-stage clinical trial data on RSV candidates for infants and adults from Pfizer and GSK.
The advisers have dedicated Friday’s session to discussing Covid-19 immunizations. After receiving a primer on current vaccine effectiveness and hospitalizations, the advisers will discuss updating the primary Covid-19 vaccine series to include the bivalent shot, which vaccine makers Pfizer-BioNTech and Moderna updated to target the BA.4/BA.5 Omicron subvariants last fall when they were most widely circulating.
Advisers to the FDA recommended the agency update the primary Covid-19 vaccine series in January. At the same meeting, the FDA’s advisers discussed a potential way forward for annual booster vaccinations, but the agency has yet to adopt their recommendations.
Now, the CDC’s advisers will discuss that question — with the added context of the nation’s public health and national emergencies slated to end in May. The panel won’t vote after hearing a CDC presentation on a potential direction, indicating that the Biden administration is carefully weighing all available data before deciding on how to coexist with the virus in the future.
IT'S WEDNESDAY. WELCOME TO PRESCRIPTION PULSE, where we eagerly await the FDA’s response to the Reagan-Udall Foundation’s evaluation of the agency’s tobacco regulatory programs. The FDA said it would have a response by mid-February.
Send news and tips to David Lim ([email protected] or @davidalim) or Katherine Ellen Foley ([email protected] or @katherineefoley).
TODAY ON OUR PULSE CHECK PODCAST, host Megan Messerly talks with Krista Mahr about her reporting on the CDC's presence in East Palestine, Ohio, the site of the train carrying dangerous chemicals that derailed, to assess potential health risks to residents.
FDA TO REVIEW RSV VACCINE — On Tuesday, Pfizer said that the FDA has accepted its application for a respiratory syncytial virus vaccine intended to protect infants up to 6 months old from the virus’ worst symptoms, Katherine reports. The FDA is slated to decide in August whether to approve the vaccine, which would be the first one administered to pregnant individuals.
The company will present topline data from its Phase III trial of the vaccine in Thursday’s meeting of the CDC’s advisers.
“If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which though well-known, has been particularly evident throughout this RSV season,” Annaliesa Anderson, Pfizer’s senior vice president and chief scientific officer of vaccine research and development, said in a statement.
The FDA already granted priority review for Pfizer’s RSV vaccine for older adults and is expected to make a decision by the end of May. The illness is more common in children under 5 than in older adults but poses the biggest threat of severe disease for seniors, young infants and those with compromised immune systems.
Thursday: Moderna will share its 2022 Q4 and year-end earnings at 8 a.m. EST.
Thursday: FDA Commissioner Robert Califf is slated to speak in the morning at Health Datapalooza.
END OF FREE RAPID TESTS FOR OLDER ADULTS RAISES CONCERN — The looming end to the Covid-19 public health emergency is prompting calls from Democrats and public health experts for Medicare to continue providing free rapid tests to older Americans, David and POLITICO’s Ben Leonard report.
Dems and the experts worry that without ready access to no-cost, over-the-counter tests, older Americans most vulnerable to severe disease won’t get rapid diagnosis and treatment. They also argue that maintaining requirements that Medicare and private insurers reimburse for eight rapid tests a month is a critical public health measure. Thousands of Americans continue to die from the virus each week.
HHS told POLITICO it is working with Congress to get the “necessary authorities” to continue offering free OTC tests for Medicare beneficiaries when the emergency ends. Medicare doesn’t typically cover over-the-counter services.
CBO LAYS OUT IRA IMPACT ESTIMATES — The Congressional Budget Office published a presentation Friday detailing its estimates of the budgetary impact of the prescription drug provisions in the Inflation Reduction Act. Overall, CBO estimates the IRA’s prescription drug provisions will reduce the federal deficit by $237 billion from 2022 to 2031, but a significant portion of that is due to the delay of the Trump administration’s rebate rule.
CBO estimates net prices for drugs selected for negotiation will decrease by 50 percent on average, and manufacturers will likely comply with the process. But there’s a catch.
“Because those drugs are projected to account for less than one-fifth of total spending net of discounts and rebates in 2031, the estimated overall reduction in net prices in Medicare will be much smaller than 50 percent,” the presentation states. “CBO estimated that average drug prices in 2031 will be 9 percent lower in Part B and 8 percent lower in Part D (net of rebates and discounts) because of negotiation.”
The inflation rebate provisions will also lower costs: CBO estimates average net drug prices in Medicare Part B and Part D will be 2 percent lower than if the inflation rebate provisions were not implemented.
PCMA LAUNCHES NATIONWIDE CAMPAIGN — The Pharmaceutical Care Management Association said Monday it is launching a “significant seven-figure” advertising campaign advocating for drug patent legislation it argues will boost competition and lower drug prices.
The pharmacy benefit manager trade lobby is also running ads in D.C. and “key states,” raising concerns about the Pharmacy Benefit Manager Transparency Act of 2023, which aims to combat the use of so-called “spread pricing” and other “deceptive prescription drug pricing practices.”
PCMA spokesperson Katie Payne argued the bill “under the guise of redundant transparency mandates would raise costs for hard-working employers and patients and set a new precedent for government authority over the private dealings of any U.S. business.”
PBMs face fire from lawmakers on both sides of the aisle who argue industry consolidation is hurting pharmacists and patients.
The FDA's Center for Tobacco Products said Friday that Matthew Farrelly will be the next director of the center’s Office of Science. Califf announced that Tracey Forfa is the new director of the FDA’s Center for Veterinary Medicine. Farrelly comes from RTI International, where he was the chief scientist and director of the Center for Health Analytics, Media and Policy.
Matthew Holman, who formerly held the position at CTP, left the agency to work for tobacco giant Philip Morris International in July; Todd Cecil and Ben Apelberg have served as acting directors of the Office of Science at CTP in the interim.
Gilbert Ghostine, the CEO of the Swiss company Firmenich, will be the chair-designate of Sandoz’s forthcoming board of directors.
The White House Office of Information and Regulatory Affairs received two FDA draft guidances for review last week:
— Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions
— Pharmacogenomic Data Submissions
OIRA is also reviewing a notice: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.