| | | | |  | | By Lauren Gardner, David Lim and Katherine Ellen Foley | With help from Krista Mahr
| | | — FDA moves dates up for its advisers to meet on Moderna, Pfizer-BioNTech pediatric vaccines for Covid-19. — Senate health leaders are preparing to formally file their FDA user fee bill as soon as this week. — FDA names CDC's Brian King as chief tobacco regulator. It's Tuesday. Welcome back to Prescription Pulse. One of your morning hosts had to get herself reacquainted with CDC's food safety guidelines after Sunday night's massive power outage in Virginia. 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).
| | | | DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED: Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today. | | | | | | | | |  FDA has set June dates to review vaccines for kids ages 6 months to 5 years. | Getty Images | PFIZER UNVEILS KID COVID VACCINE DATA — Pfizer and BioNTech released top-line results Monday showing that three pediatric doses of their Covid-19 vaccine generated an immune response in children ages 6 months to under 5 years comparable to that of two full doses in young adults — a regimen that appears to reduce cases of symptomatic disease by 80.3 percent within the age group, Katherine writes. The impressive efficacy figure raises questions about how FDA and its advisers will come down on Moderna's pediatric offering, which generated comparable immunity in kids ages 6 months to under 6 years compared to young adults but posted efficacy rates against symptomatic disease of under 50 percent. However, Moderna could have more recent efficacy data to present to advisers next month. And Pfizer and BioNTech plan to reevaluate effectiveness once 21 kids in the study develop Covid after their third shot. So far, just 10 children of 1,678 studied have come down with Covid following their last vaccine dose. FDA BUMPS UP ADVISORY COMMITTEE DATES — FDA announced on Monday it would move up the dates of its advisory committee meetings on Covid-19 vaccines for kids — June 14 for Moderna's EUA request for children ages 6 months to 17 years, and June 15 for Moderna's and Pfizer's applications for children under ages 6 months and under 5 years, respectively. The pairing of Moderna's and Pfizer's youngest-kids requests into one meeting prompted outcries from parent advocates who have accused regulators of sitting on Moderna's application to wait for Pfizer, which is expected to submit its updated data to FDA this week. FDA Commissioner Robert Califf and CBER Director Peter Marks "are both on the record denying that the FDA is waiting for Pfizer and saying that they're working on Moderna's submission as fast as they can," the grassroots group Protect Their Future said in a statement. "Today's news from the FDA does not appear consistent with those statements." The doctors speak: Two pediatric medical experts weighed in on the optics with Lauren. "You want the FDA to take time" to review each manufacturer's application, said Children's Hospital of Philadelphia's Paul Offit, a member of FDA's vaccine advisory committee. "You want the FDA not to trust what they've just been handed." The pediatrician was referring to FDA's practice of independently analyzing each applicant's data to ensure its safety, immunogenicity and efficacy findings are backed up by the math they submit to regulators. Matt Harris, a pediatric emergency medicine doctor at Northwell Health, pointed to criticism heaped on FDA for not holding an advisory committee meeting before it updated its booster recommendations for adults 50 and older as a factor that could be influencing the agency's approach to pediatric vaccines. "Part of what provides confidence to parents and physicians is that the vaccines are not rushed; that they're vetted thoroughly," he said.
| | | SENATE PLANS TO FORMALLY INTRODUCE UFA BILL THIS WEEK — The leaders of the Senate HELP Committee aim to formally introduce their bill this week to reauthorize FDA's user fee programs, a GOP Senate HELP Committee aide confirmed to POLITICO. The legislation — which lawmakers may file as soon as Wednesday — will show how the package has evolved since being debuted as a draft bill last week and whether so-called super riders are still on the train, according to one source familiar with the ongoing negotiations. A manager's package at the committee markup — targeted for June 8 — will likely be the source of more substantive changes to the legislative package. PEW: STRONGER VALID ACT NEEDED — The Pew Charitable Trusts and the American Clinical Laboratory Association are among several groups lobbying Senate lawmakers to make changes to the version of the VALID Act in the user fee package. Both groups want lawmakers to ensure FDA has adequate funds to develop and implement the regulatory overhaul of lab tests and in vitro diagnostics. But while ACLA wants a third-party review program and more flexibility for labs that modify grandfathered tests before requiring premarket review, Pew wants FDA to be empowered to conduct adequate postmarket oversight that protects public health.
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FDA Commissioner Robert Califf will testify before both the House and the Senate this week about the baby formula shortage. | Getty | CALIFF RETURNS TO CAPITOL HILL ON INFANT FORMULA — The FDA commissioner will return to the Hill this week for a fresh round of questioning about the agency's handling of the infant formula shortage. He'll testify Wednesday before the House Energy and Commerce Oversight Subcommittee alongside FDA's top two food regulators, Frank Yiannas and Susan Mayne. Representatives of three of the top formula manufacturers in the U.S., including Abbott, will also appear. Califf will head to the Senate side on Thursday, appearing before the Senate HELP Committee on the issue.
| | | CDC VETERAN TO LEAD TOBACCO REGULATION AT FDA — Brian King, deputy director for Research Translation in Centers for Disease Control and Prevention's Office on Smoking and Health, will take over as the director for the Center for Tobacco Products, FDA announced Friday. King will likely be at the helm of CTP as the office wrestles with several major tobacco regulations. E-cigarettes: This month, the agency stated that it doesn't expect to finish reviewing vape products occupying a major market share until June 30, 2023. On Friday, 11 Democratic senators wrote a letter to FDA urging the agency to remove those products from the market while evaluating their applications. Menthol cigarettes and flavored cigars: CTP issued proposed rules that would ban menthol cigarettes and flavored cigars in April. CTP is hosting two listening sessions to discuss possible unintended outcomes of these rules on June 13 and June 15. Reducing nicotine levels in cigarettes: FDA commissioner Robert Califf has hinted that the agency is still considering ways to lower nicotine levels in cigarettes. Reactions: Public health experts focused on ending youth vaping applaud FDA's decision. "King has studied the epidemiology of what has taken place, including the extent of the youth e-cig epidemic. … Expertise is different than bias. He brings expertise," Matt Myers, the president of the Campaign for Tobacco-Free Kids, told Katherine. Vaping advocates fear that King will eliminate potentially safer options for adults wishing to quit smoking. "With cigarette sales spiking for the first time in 20 years, choosing a dead-ender prohibitionist sends the message that ideology is more important than results," Amanda Wheeler, president of the American Vapor Manufacturers Association, said in a statement.
| | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president's ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | THE MONKEYPOX MESSAGING QUANDARY — On Monday, President Joe Biden backpedaled on his monkeypox risk assessment, telling reporters in Tokyo that the virus spreading quickly around Europe doesn't "rise to the level of concern" of Covid-19 and the U.S. has the vaccines to treat the disease. One case of monkeypox has been confirmed by Centers for Disease Control and Prevention in Massachusetts, and the agency is evaluating at least four more likely cases in New York City, Florida and Utah. FDA has approved two vaccines for the virus, and some 100 million doses of one vaccine is in the national stockpile today, according to CDC. "I don't think that there's a great risk to the general community for monkeypox right now in the United States," Capt. Jennifer McQuiston, deputy director of CDC's Division of High Consequence Pathogens and Pathology, said Monday.
| | | DRUGMAKERS OFTEN REFORMULATE BLOCKBUSTER DRUGS — In a paper published Friday , researchers found that drug companies were more likely to reformulate drugs that brought in $1 billion or more than they were drugs that reached a smaller number of people or already had generic versions available. Reformulating drugs — like making extended-release or combination capsules — allows companies to keep their exclusive rights to sell them. Lead author Ravi Gupta, a doctor and Health Policy Fellow with the National Clinician Scholars Program at the University of Pennsylvania, said the study revealed some ways companies keep drugs expensive. "I prescribe extended-release versions that are combination pills all the time for patients, thinking that they'll help the patients adhere to their medications," he told Katherine. But if those pills are less accessible than regular generics, it may not make sense to prescribe them, he added.
| | | FDA published two draft guidances Monday containing advice on when FDA will not seek regulatory action against blood establishments that fail to comply with donor suitability and eligibility requirements and outlining requirements for determining donor eligibility. It also published final guidance with recommendations for cutting down the risk for transmission of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease. | | | | Follow us on Twitter | | | | Follow us | | | | |
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