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Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim and Lauren Gardner | Presented by CVS Health | With help from Katherine Ellen Foley PROGRAMMING NOTE: We’ll be off for Thanksgiving on Friday but back to our normal schedule on Tuesday, Nov. 30. | | | — A House panel wants Stephen Hahn to testify and provide documents to inform its investigation into the Trump administration’s pandemic response. — FDA commissioner nominee Robert Califf’s financial disclosures paint an expensive picture of compensation he’d forfeit and recusals he’d have to make upon confirmation. — The agency Monday gave an update on its effort to get back up to speed on inspections. It’s Tuesday. Welcome back to Prescription Pulse. The president already stole our boosting-or-basting joke, so happy early Thanksgiving! 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 CVS Health: Throughout the pandemic, in communities across the country, CVS Health has been there. We’ve opened more than 4,800 COVID-19 test sites, administered 38 million tests and given 43 million vaccines. We’ve expanded access to prenatal and postpartum care via telemedicine, increased remote access to mental health services and invested in affordable housing to help build healthier communities. We’ve been on the frontlines, making health care easier to access and afford. Learn more. | | | | | | HOUSE PANEL ASKS HAHN TO TESTIFY — The House Select Subcommittee on the Coronavirus Crisis Monday called on former FDA Commissioner Stephen Hahn to agree to a transcribed interview and provide documents to inform its investigation into the Trump administration’s response to the pandemic, POLITICO’s Erin Banco reports. Lawmakers appear to be interested in exploring FDA’s decision to grant emergency use authorization to hydroxychloroquine and convalescent plasma and whether the White House interfered in the agency’s regulatory process. The committee set a Dec. 6 deadline for Hahn to hand over relevant documents and requested the former FDA commissioner sit for an interview on Dec. 13. GIVING THANKS SAFELY: RxP’S GUIDE TO THE HOLIDAY — Thanksgiving is two days away, and it’s feeling quite different from this time last year: Vaccines are safe and widely available, tests are easier to come by (depending on where you live) and booster shots are now an option for every American adult. According to White House Covid response coordinator Jeff Zients, 71 percent of adults in the U.S. are fully vaccinated, and 95 percent of all residents are eligible for immunization. Already, 36 million have availed themselves of boosters, he said. Still, Covid cases are on the rise — and starting from an even higher baseline than they did last fall — and many people won’t get full protection from boosters until after the turkey is served. What should you do if you’re planning to break bread with folks from outside your household on Thursday? Your morning hosts have pulled together a handy guide you can copy and paste to the family members in your life who just won’t make that drive-through testing appointment. First, the most important protective layer is vaccination. To gather safely “means to get vaccinated if you're not yet vaccinated and ideally to practice safe prevention measures before heading in to gathering numerous households together,” CDC Director Rochelle Walensky said Monday during a Covid briefing. She insisted this holiday is very different from last year’s when cases were north of 150,000 a day “because now we have the tools” to prevent disease. Another mitigation measure is encouraging everyone gathering — including fully vaccinated people — to get tested beforehand, using either a rapid test or a lab-confirmed PCR test if available to you. Testing is a critical hedge against someone unknowingly bringing the virus to dinner, especially if you have older family members — whose immune systems naturally weaken with age — sitting at the table. “We have more than enough testing capacity in this country to support current and potential testing news, including testing ahead of the holidays,” Zients said. Will we need another booster before next Thanksgiving? The jury’s still out on that question, White House medical adviser Anthony Fauci said. There’s a chance the durability of protection after the booster dose will last longer than it did after the initial series. But if it does wane, he said, “then we will address it. In any case, we will find out that data, we will make it public and we will act accordingly.” ANOTHER OVER-THE-COUNTER TEST AUTHORIZED — FDA on Monday granted emergency use authorization to another Covid-19 over-the-counter rapid test made by InBios. The FDA also updated BD’s EUA for its over-the-counter Covid-19 test to allow it to be used as a single test for people with Covid-19 symptoms. ICYMI: FDA, CDC OK BOOSTER SHOTS FOR ALL ADULTS — Walensky endorsed Covid-19 booster shots for all adults Friday evening, hours after the agency’s independent vaccine advisers unanimously signed off on the move. The recommendations — Americans 50 and older “should” get boosted, while anyone 18 and up “may” choose to — nodded to “the practicality of an age-based recommendation while also recognizing the thin data on the benefits of boosting young and otherwise healthy adults,” Lauren writes. | | | | DON’T MISS CONGRESS MINUTES: Need to follow the action on Capitol Hill blow-by-blow? Check out Minutes, POLITICO’s new platform that delivers the latest exclusives, twists and much more in real time. Get it on your desktop or download the POLITICO mobile app for iOS or Android. CHECK OUT CONGRESS MINUTES HERE. | | | | | | | | CALIFF’S ETHICS AGREEMENT SPELLS OUT RECUSALS — Robert Califf, President Joe Biden’s nominee to lead FDA once again, has disclosed an extensive list of companies from which he’d recuse himself on any matters that could affect their financial standings — a reflection of the extensive employment and board membership opportunities he’s amassed since leaving government in 2017. Should the Senate confirm him, Califf would have to resign from two Alphabet subsidiaries, Verily Life Sciences and Google Health, forfeiting a $2.7 million salary and millions in stock options. Califf would also have to resign as an adviser to AmyriAD Pharma, as well as relinquish board positions with Centessa Pharmaceuticals, Clinetic and Cytokinetics. Per his ethics agreement, he’d agree to recuse himself “personally and substantially” for one year from any matter to which those companies may be parties unless he’s authorized to participate. He also would divest from several entities in which he holds interests, including Amgen, Bristol Myers Squibb, Gilead Sciences and Walgreens Boots Alliance in the health care space. The documents are likely to provide ammunition to Senate Democrats who have already signaled resistance, if not downright opposition, to elevating Califf to the FDA commissioner role because of his pharmaceutical industry ties. | | | | A message from CVS Health: .png "Advertisement Image")  | | | | | | FDA GIVES UPDATE ON INSPECTION PROGRESS — FDA conducted 1,139 domestic surveillance inspections of human and animal medical products in fiscal year 2021, according to an update released by the agency Monday . That number is greater than the base-case scenario of 851 surveillance inspections of such firms predicted by FDA in its May inspection roadmap. The agency also conducted 74 foreign inspections of human and animal medical products between April 2021 and September 2021. But 52 human drug application decisions remain delayed as of September 30 solely due to pending inspections or facility assessments, according to FDA. “FDA is currently developing a plan for resuming prioritized foreign inspections, including surveillance and application-related inspections, starting in February 2022 for all commodities,” the agency’s Monday update states. | | | Biden Covid-19 testing coordinator Carole Johnson is in line to become the director of HHS Health Resources and Services Administration, POLITICO’s Adam Cancryn reports. | | | | BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now. | | | | | | | | STUBBORN COVID SURGES SIGNAL BLEAK WINTER — Though nearly 70 percent of the country has had at least one dose of a vaccine and hospitalizations have fallen from their September highs, Covid-19 cases remain high in many states, POLITICO’s Dan Goldberg reports. The trend lines portend a fresh wave in the coming weeks, and alarmed public health officials warn the country is headed for a holiday surge that could leave thousands dead. | | | DEMONSTRATORS TOOK TO VIENNA STREETS TO PROTEST COVID-19 MEASURES … — A day before the start of Austria’s latest coronavirus lockdown — and a day after the government decided to resort to mandatory vaccination — thousands of people took to the streets of Vienna Saturday to protest against the measures, POLITICO Europe’s Laurenz Gehrke reports. Sixty-four percent of Austria’s population is fully vaccinated, which is low compared to the rest of the EU. … AND A SIMILAR PROTEST IN BRUSSELS TURNS VIOLENT — Tens of thousands of demonstrators took to the streets Sunday to protest new rules intended to curb Covid-19, POLITICO Europe’s Rym Momtaz reports. They were protesting newly imposed rules, including compulsory mask-wearing for anyone 10 and older for indoor and certain outdoor activities, mandatory work from home four days a week and limits on gathering sizes. When protesters began throwing things at police, the police responded with water cannons and tear gas. | | | The Department of Veterans Affairs finally began making public how many veterans got sick and died of Covid-19 in special nursing homes meant to ease their final days, Joanne Kenen, Darius Tahir and Allan James Vestal report for POLITICO. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA extends sunscreen comment period — Late last week the FDA extended a comment period intended to collect feedback on its proposed order to amend the over-the-counter sunscreen monographs for several sunscreen ingredients. Monographs establish conditions for OTC products to be generally recognized as safe and effective (GRASE), acting almost as a “how-to” guide for bringing OTC products to market without requiring pre-market review from FDA. The FDA is currently pursuing several major changes to the way sunscreens are regulated, including updating standards for SPF (sun protection factor) labeling and the regulatory status of several long-marketed sunscreen ingredients. Based on requests from industry, the FDA has granted public stakeholders an additional 45 days in which to comment on the proposed changes. | | | Medtronic is scheduled to meet with the White House Office of Information and Regulatory Affairs to discuss durable medical equipment, prosthetics, orthotics and supplies policy issues today at 2:30 p.m. | | A message from CVS Health: At CVS Health, we’re more than 300,000 caring employees ensuring millions of Americans can access health care services.
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