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Presented by the Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Lauren Gardner and David Lim | Presented by the Pharmaceutical Care Management Association | With Katherine Ellen Foley and Alice Miranda Ollstein
| | | — CDC advisers favor extending the interval between the first two doses of messenger RNA Covid vaccines. — A Senate Democrat who’s yet to commit to supporting the Biden administration’s FDA nominee is focusing on his plans for the agency’s accelerated approval pathway. — FDA resumed domestic surveillance inspections on Monday, more than a month after the Omicron variant forced a pause in noncritical work. It’s Tuesday. Welcome back to Prescription Pulse. Your hosts are definitely not in the Wordle control group. Send tips and feedback to David Lim ( dlim@politico.com or @davidalim), Lauren Gardner ( lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley).
| | | | A message from the Pharmaceutical Care Management Association: Pharmacy benefit managers (PBMs) negotiate with big drug companies to lower prescription drug costs, helping patients save an average of $962 annually. | | | | | | VACCINE EXPERTS ENDORSE 8-WEEK SPAN BETWEEN DOSES — CDC advisers coalesced Friday around the idea of lengthening the interval between primary series Covid-19 shots for Moderna and Pfizer as cases drop and evidence in favor of that approach grows. The question is, how might federal health officials go about making that a reality? The idea of adjusting guidance on the interval came after the agency’s vaccine advisory panel heard presentations on domestic and international data for cases of two inflammatory heart conditions, myocarditis and pericarditis, after messenger RNA vaccination against Covid. Emerging data suggests a longer dosing interval of up to eight weeks between the shots may improve immune response and vaccine effectiveness while lowering the risk of those heart-related side effects. That, in turn, might help convince some younger Americans wary of the myocarditis risk to get vaccinated, panel members said. People between ages 12 and 40 in the U.S. are the most likely to be unvaccinated, a population estimated to be 33 million. The cons: A change could still be tricky. It could spur public communication challenges in a space already rife with them since the guidance would likely point to a “preferred interval” of eight weeks between primary doses while preserving providers’ ability to vaccinate after 21 or 28 days (depending on the product). Individuals for whom the benefits of quick immunization outweigh the myocarditis risk might opt for the status quo. What’s next: Advisory committee chair Grace Lee said officials need to investigate whether such a recommendation can come via clinical guidance instead of a more formal regulatory process. A CDC spokesperson didn’t have an update on Monday. CDC TO UPDATE DOSE REGIMEN FOR IMMUNOCOMPROMISED — The agency is set to update its recommended dosing intervals for immunocompromised patients to allow sooner access to boosters, Lauren reports. The move comes after some individuals with qualifying conditions have reported being turned away from getting a booster dose and as more of those patients acquire breakthrough infections. People being treated for certain moderate-to-severe conditions may not mount an adequate immune response from any Covid vaccine’s primary doses and are permitted to seek out an additional dose and, later, a booster. WALENSKY SIGNS OFF ON MODERNA APPROVAL — CDC Director Rochelle Walensky on Friday endorsed the committee’s recommendation of Moderna's two-dose Covid-19 vaccine series for all adults, days after FDA fully licensed the product. NIH-BACKED STUDY REINFORCES COVID RISKS DURING PREGNANCY — An NIH-funded study found that pregnant people with moderate to severe Covid infections were at greater risk for common pregnancy complications than those who weren’t infected. Approximately 13,000 individuals who gave birth between March 1, 2020, and Dec. 31, 2020 were studied. Of those, 2,400 contracted Covid and were more likely to need a C-section, deliver preterm, die around the time of birth or experience other complications. Importantly, mild or asymptomatic infections weren’t linked to those risks.
| | | WYDEN SEEKS MORE ASSURANCES FROM CALIFF — Senate Finance Chair Ron Wyden is not yet ready to pledge his support for Robert Califf, the president's nominee to lead FDA, and he’s pressing the cardiologist on how he’d oversee the agency’s accelerated approval pathway for new drugs. In a letter to Califf sent Friday, the Oregon Democrat listed several follow-up questions he has after a meeting with the nominee last week, focusing on exactly how he would hold drugmakers accountable for providing evidence that their products work, how he would ensure compliance and whether he will seek additional enforcement authority from Congress. IDSA BACKS MURRAY-BURR PANDEMIC PREPAREDNESS LEGISLATION — The Infectious Diseases Society of America on Friday expressed support for Sens. Patty Murray (D-Wash.) and Richard Burr ’s (R-N.C.) pandemic preparedness discussion draft, offering a list of technical recommendations it argues will improve the bill. The group also wants two pieces of legislation — the Bolstering Infectious Outbreaks Preparedness Workforce Act and the Pioneering Antimicrobial Solutions to End Upsurging Resistance Act — to be added to the package. HOUSE PASSES COMPETITIVENESS BILL WITH DRUG PROVISIONS — The House on Friday passed a bill, H.R. 4521, to bolster U.S. economic competitiveness with China. The bill includes mandatory recall authority for FDA, a power that’s long been on the agency’s wishlist. It would broaden its existing authority from “controlled substances” to all “drugs.” The legislation must be reconciled with a similar Senate measure, S. 1260, so it’s unclear whether the provision would emerge from the process intact. The House bill also includes sections intended to promote advanced manufacturing of prescription drugs and the upkeep of strategic medical supply stockpiles.
| | | FDA RESUMES DOMESTIC SURVEILLANCE INSPECTIONS — FDA on Monday started resuming standard domestic inspections because of the decrease of Covid-19 infections nationwide. The highly transmissible Omicron variant led the agency to pause noncritical in-person inspections in December to “ensure the safety of its employees and those of the firms it regulates.” “Planning for additional foreign surveillance inspections is ongoing, with an anticipated goal of conducting foreign prioritized inspections starting in April,” FDA said in its announcement. A new Government Accountability Office report published Monday called on FDA to overhaul how it operates its foreign inspection program, urging the agency to strengthen and implement its unannounced inspection pilot scheduled to roll out in early 2022. “Maintaining a robust investigator workforce is particularly important as FDA will likely continue to face a backlog of surveillance inspections in future years in light of the COVID-19 pandemic,” the GAO report states. FDA ADVISES CONSUMERS NOT TO USE UNAUTHORIZED COVID-19 TEST — People should not use an at-home Covid test called the E25Bio COVID-19 Direct Antigen Rapid Test, FDA warned on Friday. FDA hasn’t cleared the test for consumer use and is concerned it may provide false results. ANOTHER UNAUTHORIZED COVID TEST REMOVES ITSELF FROM THE MARKET — SD Biosensor, Inc., announced earlier this month it is pulling one of its at-home Covid-19 test from the U.S. market out of “an abundance of caution”. A different SD Biosensor test received an EUA on Dec. 24, 2021.
| | | |   | | | | | | SYNTHETIC NICOTINE: UNREGULATED AND INCREASINGLY POPULAR — While top tobacco regulators dawdle over the e-cigarette industry’s fate, another class of vape is quietly restocking the market with unregulated, flavored products — and it’s drawing in a growing number of kids, Katherine reports. To users, synthetic, or “tobacco-free,” vapes are identical to their tobacco-derived products. But because of an obscure loophole, they skirt FDA’s regulatory authority under the Center for Tobacco Products. That means sellers, including Puff Bar, can legally sell flavored vapes without consequences — and teens are flocking to them. “Whatever drops in the bucket they’ve made to try to combat youth e-cigarette use, synthetic nicotine has completely undermined it,” Natalie Hemmerich, a senior staff attorney at the Public Health Law Center, who focuses on federal tobacco policy, said.
| | | TRI-AGENCIES CLARIFY AT-HOME COVERAGE REQUIREMENTS — The Departments of Labor, Health and Human Services and the Treasury on Friday released clarifying guidance on the federal requirement for private insurers to cover over-the-counter Covid-19 tests.
| | | BIOGEN AND XBRANE BIOPHARMA REACH AGREEMENT FOR ARTHRITIS BIOSIMILAR — Biogen will pay Xbrane Biopharma $8 million as part of a licensing agreement for Xcimzane, a biosimilar candidate to treat rheumatoid arthritis, the companies announced Monday. Xbrane will develop preclinical iterations of the therapy, while Biogen will handle any remaining development and clinical studies. Should Xcimzane succeed in trials, Biogen could pay Xbrane up to $80 million on top of treatment royalties.
| | | Bakul Patel starts this week as the chief digital health officer of global strategy and innovation at FDA. Patel has spent more than a decade with the agency handling digital health initiatives and medical device policy.
| | | FDA released draft guidance for incorporating clinically relevant immunogenicity information into the labeling of therapeutics with immunogenicity assessments. FDA released draft guidance outlining formal meeting procedures for over-the-counter drug developers and the agency.
| | | | A message from the Pharmaceutical Care Management Association: PBMs advocate for patients in the fight to keep prescription drugs accessible and affordable. Here are five ways PBMs improve patient outcomes:
• Keeping patients safe by working with their health care team and reviewing their prescriptions to prevent potentially dangerous interactions.
• Negotiating rebates from drug manufacturers and discounts from pharmacies to make drugs more affordable.
• Supporting proposals to update Medicare Part D to improve affordability and increase choice and competition, including rewarding pharmacies that promote quality care and improve clinical outcomes.
• Offering home delivery of chronic medications through mail-service pharmacies.
• Providing real-time benefit tools so physicians and patients know, at the point of prescribing, what drugs are covered by insurance — and what patients’ cost-sharing will be.
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