| | | | | |  | | By Katherine Ellen Foley and David Lim | Presented by Pharmaceutical Care Management Association | | | | | | 
A vaccine that protects infants from RSV is one step closer to FDA approval. | Brandon Bell/Getty Images | FIRST RSV VACCINE FOR BABIES ENDORSED — Independent advisers unanimously recommended Thursday that the FDA approve the first vaccine that protects infants against respiratory syncytial virus. Advisers voted 14-0 that Pfizer’s vaccine candidate, administered to pregnant individuals in their second or third trimester, demonstrated that it would effectively protect infants from severe cases of the disease. In late-stage clinical trials, the vaccine was more than 80 percent effective at preventing severe RSV in newborns up to 3 months old and about 70 percent effective at preventing severe disease in babies up to 6 months old. But they had some safety concerns. The panel voted 10-4 that the vaccine was safe for babies, citing concerns that some data indicated the shot could lead to risky pre-term births. Given the risk of infants developing severe disease tied to RSV, outside experts decided the benefits outweighed the risks. The CDC estimates the viral infection results in up to 80,000 pediatric hospitalizations annually and as many as 300 deaths. A growing landscape: Sanofi and AstraZeneca have asked the FDA to approve a monoclonal antibody RSV treatment for infants. Though not a vaccine, the antibody would offer some protection against the disease during babies’ first RSV season, which typically occurs over the fall and winter, and for the first and second RSV seasons for babies with additional health risks. The FDA’s advisers will meet in June to discuss the companies’ application, and the agency will decide by the end of September. The European Commission approved the antibody last year. Merck is developing a similar monoclonal antibody for RSV in infants, but the company hasn’t released clinical data yet. What’s next: The FDA will decide on Pfizer’s RSV vaccine for infants in August. IT’S FRIDAY. WELCOME TO PRESCRIPTION PULSE. The FDA’s Brian King told attendees at the Food and Drug Law Institute’s annual conference this week that Reagan-Udall’s review of the agency’s tobacco program felt like “baptism by blowtorch.” That resonates deeply with your co-hosts. Send news, tips and compliments to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Robert King, who reports on a Senate panel that’s investigating the frequency of Medicare coverage denials for beneficiaries and the use of artificial intelligence — and the panel is beginning by demanding records from the largest Medicare Advantage insurers: Humana, UnitedHealthcare and CVS.
| | | | | A message from Pharmaceutical Care Management Association: Don’t let their smoke and mirrors fool you: high drug costs start and end with big drug companies. While pharmacy benefit companies are lowering costs, drug companies are busy blaming everyone in the supply chain but themselves to avoid culpability for the affordability challenge some patients face. Without more competition and accountability, big drug companies will continue to abuse the patent system and block affordable alternatives – making life-saving medications unaffordable for American families. Learn more. | | | | | | | 
President Joe Biden is asking Congress to boost FDA funding to $7.2 billion in fiscal 2024. | Andrew Harnik/AP Photo | FDA FUNDING BILL INCHES FORWARD — The House Appropriations Subcommittee in charge of FDA funding advanced its fiscal 2024 spending bill Thursday by voice vote to the full committee despite vocal Democrat objection. The bill, if signed into law as written, would give the FDA $3.5 billion in taxpayer funds, a number that would total $6.6 billion when user fees are added. President Joe Biden had asked Congress to boost the agency’s funding to $7.2 billion in fiscal 2024, an increase of $521 million over fiscal 2023. House Appropriations Committee ranking member Rosa DeLauro (D-Conn.) slammed policy riders in the bill that would prevent the FDA from using funds to enforce a coming ban prohibiting menthol cigarettes and flavored cigars or limit the amount of nicotine in cigarettes. “What will be the health consequences?” DeLauro said. “What will be the life expectancy consequences?” Limiting telehealth prescribing of abortion pill: The GOP-led funding bill would nullify the FDA’s January decision to remove the in-person dispensing requirement for mifepristone, the most commonly used abortion medication, and prohibit establishing, implementing or enforcing a similar policy.
| | | | GET READY FOR GLOBAL TECH DAY: Join POLITICO Live as we launch our first Global Tech Day alongside London Tech Week on Thursday, June 15. Register now for continuing updates and to be a part of this momentous and program-packed day! From the blockchain, to AI, and autonomous vehicles, technology is changing how power is exercised around the world, so who will write the rules? REGISTER HERE. | | | | | | | | CUSTOMS TO DETAIN ILLEGAL VAPES — The FDA has issued an import alert to Customs and Border Protection, saying that unauthorized e-cigarettes should be detained without inspection. The alert identified more than 20 companies in China, South Korea and the U.S. that the agency said have been illegally manufacturing or shipping vapes to the U.S. without FDA marketing authorization. The import alert targeted vapes branded as Elf Bar, Esco Bar and Eon Smoke, which are fruity-flavored, disposable e-cigarettes popular among minors. In March, those brands sold more than 215 million units across the U.S., accounting for 12 percent of the e-cigarette market, according to data from Alex Liber, an assistant professor of oncology at Georgetown University’s School of Medicine who tracks tobacco sales. Elf Bar made up most of the sales. “I want to reinforce unequivocally that nothing is off the table when it comes to enforcement; we are going to use all of the tools in our toolkit to make sure that folks obey the law,” Brian King, director of the FDA Center for Tobacco Products, said Thursday at the FDLI’s annual conference. The agency also issued marketing denial orders Thursday for more than 250 flavored vapes from the company Mothers Milk WTA. The agency said the company failed to prove its products wouldn’t appeal to minors who have never used nicotine. ADVISERS DISCUSS MANUFACTURING STANDARDS — The FDA’s Tobacco Products Scientific Advisory Committee met Thursday to discuss CTP’s proposed rule to establish manufacturing standards for tobacco products. The FDA requires that each center develop such standards for the products it regulates and that the agency’s outside experts discuss the proposed rules. CTP has been operating since 2009 without such rules. “It’s not a sexy rule, but it’s important for the maturation of the center,” former CTP director Mitch Zeller told Prescription Pulse.
| | REVOLVING DOOR FOR FDA LAWYERS — The FDA’s ability to regulate the safety and efficacy of medical products is “under attack like never before,” FDA Commissioner Robert Califf said at FDLI this week. “I’ve participated in many discussions about the revolving door for biomedical scientists, but I’ve heard little discussion about the revolving door for lawyers, and while the considerations are not identical, there are significant similarities that deserve more attention and debate,” Califf said. CONGRESS FORGETTING COVID LESSONS? The politicization of the Covid-19 pandemic is making it more challenging for the government to invest in new vaccines and therapeutics, former FDA Commissioner David Kessler and former Sen. Richard Burr (R-N.C.) said Thursday at the FDLI’s annual conference. Kessler, who served as the Biden administration’s top Covid science official until January, said it is “unacceptable” that there are no monoclonal treatments that work against current variants and added it is “ridiculous” that there are only two antiviral treatments. Both leaders expressed concern that the U.S. is not politically prepared for the next pandemic in part due to the deterioration of trust in public health agencies. The government must do more to explain its policy decisions in real time to maintain trust from Congress, Burr argued. “How long will Covid remain in the minds of members of Congress?” Burr said. “It’s already beginning to fade. You’re seeing it in this year’s appropriations and debates.” FDA TO APPROVE OVERDOSE REVERSAL DRUG? The agency is expected to decide by Monday on a nasal spray version of nalmefene, an opioid overdose reversal drug. Manufactured by Indivior, the drug is similar to the approved naloxone but is more powerful.
| | | | A message from Pharmaceutical Care Management Association:   | | | | | Billy Dunn, former head of the FDA’s Office of Neuroscience who played a key role in the agency’s approval of controversial Alzheimer’s drug Aduhelm, has joined the board of Prothena, a company developing treatments for neurodegenerative disease.
| | | | DON’T MISS POLITICO’S HEALTH CARE SUMMIT: The Covid-19 pandemic helped spur innovation in health care, from the wide adoption of telemedicine, health apps and online pharmacies to mRNA vaccines. But what will the next health care innovations look like? Join POLITICO on Wednesday June 7 for our Health Care Summit to explore how tech and innovation are transforming care and the challenges ahead for access and delivery in the United States. REGISTER NOW. | | | | | | | | | On Wednesday, the FDA put out draft guidance for developing pediatric drugs when they fall under the purview of the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act. On Thursday, the FDA issued dozens of product-specific guidances for developing generic versions of drugs. The Supreme Court unanimously sided with Sanofi and Regeneron on Thursday to say that Amgen cannot monopolize the market for antibodies that can lower certain types of cholesterol.
| | A message from Pharmaceutical Care Management Association: Big drug companies choose to set unaffordable prices for many Americans – then add insult to injury by blocking competition in the prescription drug market to maximize their profit, and drive drug costs higher at the expense of patients.
Rather than limiting choice for employers and restricting options for achieving savings, Congress should act to strengthen competition in the market, and end big drug companies’ egregious abuse of the patent system that blocks affordable alternatives – such as generics and biosimilars – from entering the prescription drug market.
Patent thickets on five of the 10 top-selling drugs in the U.S. resulted in more than $500 billion in additional sales, and patent abuse blocking biosimilars from the market alone will cost patients an estimated $30 billion over the next decade.
While big drug companies are focused on profits, pharmacy benefit companies are driving costs down and securing savings for patients, employers, and taxpayers. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
