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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Lauren Gardner and David Lim | With help from Katherine Ellen Foley PROGRAMMING NOTE: Prescription Pulse will not publish on Tuesday, Oct. 12. We'll be back on Wednesday, Oct. 13. | | | — Pfizer and BioNTech formally sought emergency authorization Thursday for use of their Covid-19 vaccines in some children. — The White House is frustrated with Moderna’s resistance to increasing international donations of its Covid vaccine. — FDA issued a wave of warning letters to e-cigarette manufacturers that received marketing denial orders. It’s Friday. Welcome back to Prescription Pulse. Please give a round of applause to 480 Otis, an Alaskan bear who’s filling out nicely for the long winter ahead and has nothing to do with pharma news. Send tips 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). | | | PFIZER FILES EUA FOR KID COVID SHOT — It’s official: The request is in for FDA signoff on the Pfizer vaccine for kids ages 5 to 11, Katherine reports. The emergency use authorization filing could clear the way for about 28 million children domestically to be eligible for immunization in a matter of weeks. The FDA took the unusual step of scheduling an Oct. 26 meeting of its external vaccine advisory committee to discuss the Pfizer-BioNTech shot for children before the companies made their EUA bid official. The companies are seeking authorization for those children to receive one-third of the adult dosage in a two-shot series three weeks apart. Regulators and independent advisers were already expected to pay close attention to any adverse side effects experienced during the pediatric trials, especially given myocarditis cases seen in some male teens and young adults. But other countries’ decisions to limit children to one vaccine dose to try to stave off the worst events could prompt further discussion of that option when the vaccine panel meets later this month. It’s worth noting, though, that the U.S. is in much more treacherous territory with respect to Covid infection rates than many other countries, making the risk-benefit calculus for kids much different. This week in Twitter spitballing: Count former Biden Covid adviser Andy Slavitt among those putting forth dates for when kids will be able to get their shots. “5 to 11 year olds will be able to be vaccinated by Halloween,” he tweeted Thursday. Anthony Fauci, the president’s top medical adviser, has also suggested the shots could be available to children before the holiday, though he’s since walked that back. If you’re reading Rx Pulse, you likely already know this, but we’re going to reiterate it anyway: If FDA advisers recommend the vaccine for kids on Oct. 26, the agency and then the CDC and its own advisers could act in rapid succession to give the regulatory green light. But it also could take longer; the data and the points raised during discussion in these meetings could prompt the agencies to take more time. And coming off last month’s booster shot kerfuffle, the agencies likely are extra sensitive to balancing speed with meticulous review. Not to be outdone: Johnson & Johnson applied Tuesday for emergency authorization for its Covid-19 shot to be used as a booster in adults some months after the initial dose, Lauren writes. MODERNA BALKS AT WHITE HOUSE PRESSURE ON DONATIONS — Moderna is resisting pressure from the federal government — a key scientific and financial backer of its Covid-19 vaccine — to increase donations of the shot to other countries, POLITICO’s Erin Banco, Adam Cancryn and Sarah Owermohle scooped. The Biden administration has sought to lean on the company to help it fill its international donation commitments, but Moderna is worried about its ability to fulfill both its domestic and foreign responsibilities. The company announced plans Thursday to build a vaccine production hub in Africa to make up to 500 million doses a year, though it hasn’t selected a site or a target opening date. But that wasn’t enough to shield Moderna from criticism from those who want the developing world to have greater access to both the vaccines and the intellectual property around them. “The world would be far better served if instead Moderna cooperated with the World Health Organization and South Africa to accelerate the development of the world’s first mRNA hub, which already is underway and is intended as a learning facility for manufacturers worldwide,” Peter Maybarduk, director of Public Citizen’s Access to Medicines program, said in a statement. AT-HOME TEST SUPPLY ON TRACK TO QUICKLY EXPAND, BIDEN ADMIN SAYS — White House health officials announced Wednesday that the nation’s supply of at-home Covid-19 tests is on track to triple by early November, driven by recent government investments and the FDA’s emergency authorization of a test from ACON Laboratories. The Biden administration is buying an additional $1 billion of at-home tests they say will contribute to a quadrupling of the market to 200 million tests per month in December. Overheard on the gram: “I’m optimistic about the future after this Delta wave,” Scott Gottlieb, the former head of FDA, said in a Tuesday night Instagram live feed with the Westport Moms Community. “Into 2022, we’re going to have a new orally available drug, widespread diagnostic testing in the homes [and] we’re going to probably end up reformulating vaccines at some point.” On the future of masks: “I don’t think there will be mask mandates in 2022,” Gottlieb said. Children will be vaccinated in schools, he added, and while there will be more cultural acceptance of wearing masks, they won’t be necessary. “Eventually,” he added, “pandemics end.” | | | | Registration is OPEN for Breakthrough Summit 2021, the most important rare disease conference of the year! On Oct. 18 and 19, the National Organization for Rare Disorders will host the virtual Rare Disease and Orphan Products Breakthrough Summit. The Summit brings together the rare disease community from across the globe, including experts from patient advocacy, government, industry, media and academia, to discuss the current and critical topics in rare diseases. For access to two days of networking and dynamic programming on topics including drug pricing, genetic testing, Covid-19, equity and inclusivity, REGISTER NOW. | | | | | | | | BIDEN CLOSES IN ON NAMING FDA COMMISSIONER NOMINEE — President Joe Biden is close to naming a nominee to be the permanent FDA chief after a monthslong search, people familiar with the process told POLITICO. Though the White House was already nearing a selection, the announcement that NIH Director Francis Collins would step down accelerated the timeline. On Tuesday night, Biden responded to questions about the FDA search by telling reporters he’d be “talking about that in a little bit.” Current acting Commissioner Janet Woodcock can only remain atop the agency for another month unless a permanent candidate is formally nominated. FDA MODIFIES DRAFT GUIDANCE ON COMPOUNDED DRUGS FOR HOSPITALS AND HEALTH SYSTEMS — FDA updated its draft guidance for health care providers making and administering compounded drugs to make it easier for hospitals to meet the needs of patients who require unique combinations or alterations of therapies, Katherine reports. The agency on Wednesday dropped a provision that limited compounding facilities to shipping drugs to health care facilities within one-mile radius, and now says that it will not take action against facilities that make batches of compounded drugs without specific patients in mind — provided that hospitals ultimately use the drugs for patients or discard any unused portion within a day. | | | INDUSTRY SAYS TOBACCO TAXES WILL BOOST THE ILLICIT MARKET — A group tied to major cigarette manufacturers is warning Congress that if lawmakers tax tobacco to help pay for President Joe Biden’s domestic agenda, illegal suppliers will market smokes to children, POLITICO’s Hailey Fuchs writes. The National Association of Convenience Stores, whose members include Altria Group, Reynolds American Inc. and JUUL Labs, said that if the price of tobacco products spikes, buyers would move to the tobacco black market where sellers don’t abide by standard regulations and often prey on young people. The groups outlined their concerns in a Sept. 14 letter to Congress. The pushback comes as Democrats propose to increase the excise tax on tobacco and nicotine products, one of many pay-fors floated to subsidize the massive social and climate spending bill championed by members of the party. It would effectively double the federal excise tax on small cigars and cigarettes, and it would increase the tax on chewing tobacco from 50.33 cents to $10.70 — more than 21 times its current level. It also establishes a new tax on e-cigarettes. Supporters argue the tax would reduce the use of tobacco products, especially among children, and prompt others to quit entirely. FDA WARNS E-CIG COMPANIES SELLING REJECTED PRODUCTS — The FDA announced it issued 20 warning letters to e-cigarette manufacturers across the country that had received marketing denial orders for the products they applied to sell in premarket tobacco applications. It also issued warning letters to eight other companies that didn’t file complete applications, or didn’t file applications at all. In total, the 28 companies have listed a combined total of more than 600,000 e-cigarette products. The agency published the letters on Thursday. They went to companies including Sir Vapes a Lot, The Plume Room and Sadboy LLC. Warning letters are the first step of enforcement FDA can take on companies selling illegal products; if they’re found to continue marketing goods illegally, the agency can impose financial penalties ranging from hundreds to thousands of dollars. “One of our top priorities is ensuring that manufacturers are held accountable for marketing unauthorized tobacco products,” Mitch Zeller, the head of FDA’s Center for Tobacco Products, said in a statement. “It is our responsibility to make sure that tobacco product manufacturers comply with the law to protect public health and we’ll continue to hold companies accountable for breaking the law.” But still, no Juul: It’s been nearly a month since FDA’s deadline to make decisions on PMTAs, and it still has yet to issue one for any of the largest players. | | | MODERNA SEES COVID-19 BOOSTERS IN FUTURE COMBINATION VACCINES — Moderna President Stephen Hoge said Covid-19 boosters will likely become common in other respiratory virus inoculations, at the Chardan’s Virtual Fifth Annual Genetic Medicines Conference on Tuesday. “We've always intended to do combinations,” he said. “Now we know those combinations will almost certainly include Covid boosters.” Hoge predicts these combination shots will come to market after FDA approves their individual components. The company has already filed for full regulatory approval for its Covid-19 vaccine, and is in clinical trials for its mRNA-based flu vaccine. In September, the company announced that it was working on a combination flu-Covid-19 booster, but didn’t clarify further details. | | | FDA TAKES ACTION ON SURGICAL STAPLER SAFETY — The FDA on Thursday issued new recommendations for health care providers that aim to protect patients and reduce the risk of using surgical staplers. The agency also issued final guidance on labeling recommendations for the medical devices, as well as a final order reclassifying surgical staplers for internal use as Class II devices with special controls subject to premarket review. The new actions come more than a year after Kaiser Health News’ Christina Jewett published an investigation into the safety of the devices and how adverse events tied to them are reported to the FDA. | | | WHO RECOMMENDS WIDE USE OF MALARIA VACCINE — A first-ever malaria vaccine should be deployed widely, the World Health Organization said Wednesday. The vaccine, developed by GlaxoSmithKline, was 30 percent effective in preventing hospitalizations with severe cases of malaria in clinical trials and a pilot project that vaccinated 800,000 children in Ghana, Kenya and Malawi. | | | | TELL US WHAT YOU THINK: Do you listen to POLITICO podcasts? We want to hear from you! Tell us what you like, what you could do without, and what you want to see in the future from the POLITICO Audio team! Your responses will help us improve our offerings and tailor our podcast content to better fit your needs. Find the survey here. | | | | | | | | Christine Simmon has been promoted to executive vice president for policy and strategic alliances at the Association for Accessible Medicines. She also serves as executive director of the group’s Biosimilars Council. Law and lobbying firm Williams & Jensen has hired Grant Barbosa, a legislative assistant to now-Vice President Kamala Harris when she served in the Senate, from Emergent BioSolutions, where he was a senior director of federal government affairs. Melanie Anne Egorin on Thursday was sworn in as HHS assistant secretary for legislation. | | | A majority of Americans now support Covid vaccine mandates for public school students 12 and older, though divisions exist along racial and party lines, according to a new POLITICO-Harvard poll. Check out this POLITICO data story showing where President Joe Biden’s large-employer vaccine mandate is likely to drive up Covid vaccination rates — and where it may miss. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA unveils new templates to boost diagnostics — The FDA’s diagnostics division (known as OIR) this week updated several template documents intended to guide Covid-19 test developers through the emergency use authorization process. These templates were issued early in the pandemic, but they hadn’t yet been updated in 2021 to reflect the changing pandemic landscape. In the first major overhaul this year, all of these templates now provide recommendations on how Covid-19 test developers should address the challenges of the pandemic, such as viral variants and difficulty accessing certain samples. While “you would see a lot of changes if you were to do a red line compare” with the old versions, said OIR Associate Director Toby Lowe, the changes largely echo advice that FDA’s diagnostic leadership has been giving for several months during regular industry calls and represent “no major policy changes” for most companies. If anything, diagnostics firms might see a more reliable path through the agency, with all current regulatory recommendations outlined in the templates. | | | HHS on Thursday published its 2021 Climate Action Plan. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
