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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 Sarah Owermohle | | | — An old hand is on deck to return as FDA chief. But some Democrats are already raising concerns. — A pair of House lawmakers are introducing legislation to redouble efforts to identify cures and treatments for chronic diseases. — FDA heads to court Thursday to defend how long it’s taken to limit menthol in tobacco products. It’s Tuesday. Welcome back to Prescription Pulse (Taylor’s version). Lauren will be in West Virginia this week on assignment — any food recommendations for Charleston, Rx Pulse readers? Send tips and Swiftie memes 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. | | | | | | CALIFF IS THE PICK — Former FDA Commissioner Robert Califf is on deck to return for a second tour atop the agency after a lengthy search by the Biden administration for a permanent leader. President Joe Biden on Monday formally sent the Califf nomination to the Senate. A HELP Committee aide told POLITICO a hearing on the nomination will be scheduled “as soon as possible.” If confirmed by the Senate, Califf will play a key role in charting the government's wider pharmaceutical and tobacco policy ambitions — as well as managing growing scrutiny of the FDA's drug approval process. But several Senate Democrats are already signaling they will not support his nomination, meaning Republican votes will be needed for Califf to be confirmed. Sens. Joe Manchin of West Virginia and Richard Blumenthal of Connecticut — both of whom voted against Califf’s nomination in 2016 — have signaled their opposition once again over concerns about his ties to the drug industry and FDA’s track record on opioids. Stacy Cline Amin, an attorney at Morrison & Foerster and former FDA chief counsel, told POLITICO she is interested to see how Califf responds to questions about real-world evidence and clinical trial design during his confirmation hearing. “It was one of his top priorities as commissioner, but I have seen some comments from him more recently looking critically at some of the use of real-world evidence and different forms of clinical trials during Covid-19,” Cline Amin said, citing a recent panel where Califf spoke. | | | | We want to hear from you! What do you think about the POLITICO Prescription Pulse newsletter? Fill out our short, 7-minute feedback survey and tell us what you want to see in Prescription Pulse and other POLITICO Health care newsletters. | | | | | | | | HOUSE LAWMAKERS UNVEIL CURES 2.0 — Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) are proposing a range of new drug research, a federal telehealth overhaul and $6.5 billion for President Joe Biden’s biomedical research agency vision, according to draft text of the sprawling health bill obtained by PULSE’s Sarah Owermohle. The Cures 2.0. bill, to be released later this morning, would require a series of long Covid-19 studies and support programs, research into Covid health disparities and a push for more diversity and real-world evidence in clinical trials. And besides awarding billions to Biden’s proposed Advanced Research Projects Agency for Health — recently booted from the social spending package — Cures 2.0 also squeezes in the Telehealth Modernization Act and a measure establishing subscription payments for new antimicrobial drugs in a bid to incentivize development of new antibiotics. Still, the long-anticipated bipartisan health package doesn’t have a clear road to passage. The legislative agenda is crowded in the weeks ahead as lawmakers hammer out the fiscal 2022 budget and divisive social spending priorities. | | | SCOOP: MODERNA NEARS DEAL ON GLOBAL VACCINE DONATIONS — The messenger RNA vaccine maker is close to an agreement to pledge millions more doses of its Covid shot to low- and middle-income countries next year, two people with knowledge of the matter told Sarah and POLITICO's Adam Cancryn and Erin Banco. The number of doses Moderna will commit is still being finalized but could total hundreds of millions. And under the tentative deal, the company would sell its vaccine to COVAX at about $7 a dose, lower than it's charged the U.S. and other individual countries. HHS REVOKES TRUMP-ERA POLICY LIMITING PREMARKET REVIEW OF LDTS — The Biden administration on Monday said it is withdrawing a Trump-era legal determination that FDA lacks the authority to require premarket reviews of laboratory developed tests for Covid-19 and other conditions. The controversial decision, pushed by former HHS Secretary Alex Azar last August despite the objections of then-FDA Commissioner Stephen Hahn, affects oversight of tests created and used within a single laboratory. Bob Charrow, who served as HHS general counsel under Azar, worked for months last year to build a legal case that FDA did not have the authority to regulate LDTs due in part to a lack of notice-and-comment rulemaking by the agency. But other former senior government officials are sharply critical of Charrow’s memo. "HHS tried to make law through a web posting; you can't do that," Cline Amin said. "The legal memo that was leaked was inaccurate, incoherent and inconsistent. I think FDA believes its legal footing is strong." The FDA on Monday also announced that moving forward the agency “generally expects” new Covid-19 tests entering the market will obtain an emergency use or traditional marketing authorization. The agency previously allowed test developers to market Covid-19 tests as long as they validated its performance and notified the agency. The goal was to speed the availability of more testing, but the agency said that policy “led to some poorly performing tests being offered prior to FDA review.” NIH KICKS OFF STUDY OF KIDS WHO HAD COVID — The National Institutes of Health enrolled its first participant Monday in a long-term study of children who previously tested positive for Covid, the agency announced. Researchers will track up to 1,000 kids and young adults over three years to assess the disease’s effects on physical and mental health. ‘VAX-OR-TEST’ CHALLENGE HEADS TO LOTTERY — A lottery is expected to take place Tuesday to determine which federal appeals court will hear a consolidated legal challenge of the Biden administration’s Covid vaccine-or-test mandate for many private businesses. The drawing comes after a Louisiana-based circuit extended a stay of the rule late Friday, POLITICO’s Rebecca Rainey reports. The requirement would apply to workplaces with more than 100 employees who would need to submit to weekly tests if they refuse the shots. | | | | 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. | | | | | | | | FDA FEELS THE HEAT ON MENTHOL — FDA heads to federal district court Thursday to defend itself against anti-tobacco groups challenging the agency for dragging its feet on banning menthol. The case is being argued as regulators continue to grapple with a related issue: whether and how to limit minty varieties of e-cigarettes and vapes while menthol cigarettes are still on the market, POLITICO’s Katherine Ellen Foley writes. An FDA spokesperson said regulators are working on a menthol policy, which the agency has said is coming by April, and will finish its outstanding e-cig reviews, but didn’t comment on the overlap. Research has shown that Black Americans overwhelmingly gravitate to menthol cigarettes after decades of targeted marketing. The minty flavor helps mask the burning tobacco, making it easier for new smokers to get hooked. But some experts believe FDA is slow-walking limits on menthol-flavored e-cigs so as not to push those users to menthol cigarettes before they’re removed from the market. | | | | A message from CVS Health:   | | | | | | THE WEEK AHEAD IN SOCIAL SPENDING LAND — Congress is back in town, so get ready for another week of will-they-or-won’t-they, social spending package (H.R. 5376) edition. In a warning shot toward everyone’s weekend, the Congressional Budget Office Monday said it would release its score of the bill by the end of the day Friday at the latest. House Democrats want to vote on the measure this week, but some moderates have demanded to see its total cost beforehand, leaving timing up in the air. Midterm messaging: The bill hasn’t even passed yet, but POLITICO’s Alice Miranda Ollstein and Laura Barrón-López report that Dems may find themselves in a bit of a pickle promoting the legislation while stumping for the midterms . That’s because many of the bill’s prescription drug goodies wouldn’t kick in until well after the 2022 elections. “It may all feel a little theoretical rather than tangible for voters, and that poses a challenge for Democrats in the midterm elections,” said Larry Levitt, the executive vice president of the Kaiser Family Foundation. Remember the Affordable Care Act and the 2010 midterms? Looking to the Senate: Of course, the bill is far from a fait accompli. Senate Republicans are poised to challenge the bill’s drug price control mechanism for private insurers with the chamber’s parliamentarian, and Dems have no obvious Plan B if they succeed, Alice writes. | | | The National Academy of Medicine is hosting a two-session webinar Thursday to cover its findings and recommendations on advancing pandemic and seasonal flu vaccine preparedness. | | | John Funderburk joins the Federation of American Hospitals as senior vice president of external affairs. He most recently was vice president for advocacy at the Alzheimer’s Association and worked at the American Medical Association as regional political director. Elise Argall is joining the Alzheimer’s Association as senior associate director of public policy communications. She previously was communications director for Rep. Guy Reschenthaler (R-Pa.). Alfred Sandrock, Jr. is retiring as Biogen’s head of research and development. Priya Singhal will step in on an interim basis until a permanent successor is identified. | | | NOVAVAX SUBMITS COVID-19 VACCINE TO SOUTH KOREAN REGULATORS — Novavax announced Monday it submitted its Covid-19 vaccine to South Korea’s Ministry of Food and Drug Safety. “Today's submission reflects the first BLA submission for full approval of our COVID-19 vaccine anywhere in the world, with more anticipated to follow,” Novavax CEO Stanley Erck said in a statement. CANADA GREEN-LIGHTS MODERNA BOOSTER FOR ADULTS — Health Canada has authorized a booster shot of Moderna’s Covid-19 vaccine for all adults who are at least six months past their second primary series dose. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA’s top oncology officials preview focus on overdue studies, drug dosing — Speaking last week at the Friends of Cancer Research group’s annual meeting, top officials with FDA’s Oncology Center of Excellence (OCE) previewed what’s next for the agency, in particular for cancer drug reviews and approvals. According to Rick Pazdur, the head of the OCE, industry should expect a heightened focus on what he referred to as “delinquent accelerated approvals,” or cases in which a company has not completed studies to confirm the benefits of their drug as required by FDA as a condition of approval. Marc Theoret, Deputy Center Director of the OCE, also previewed a new focus on cancer drug dosing. The idea, according to Theoret and Pazdur, is that companies often focus on maximum tolerated doses (i.e., the highest possible dose that is tolerable without unbearable side effects) for cancer drugs instead of doses that confer a specific benefit. That can subject patients to unnecessary side effects, especially as more companies develop targeted mechanisms of action that don’t rely on chemotherapy. OCE is in the process of finalizing a guidance on this new approach, which Pazdur has previously called more of a “requirement” that they will enforce. | | | The potential cost of an expensive Alzheimer’s drug is driving up premiums for Medicare Part B enrollees, POLITICO’s Adam Cancryn writes. | | 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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