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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, Lauren Gardner and Katherine Ellen Foley | Presented by CVS Health | | | | — FDA issues first-ever authorization for an e-cigarette and tobacco- flavored pods, arguing they provide a benefit to smokers who switched to vaping. — FDA’s independent advisory committee on vaccines meets Thursday and Friday to decide whether to recommend booster doses of Moderna’s and Johnson & Johnson’s Covid-19 vaccines. — FDA touts a Booz Allen Hamilton review of its emergency use authorization process for Covid-19 diagnostics. It’s Wednesday. Welcome back to Prescription Pulse. There are myriad words used to describe FDA actions, but an informal Twitter poll reinforces to your co-author that “authorized" means too many different things. 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). | | 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 more than 32 million tests and given more than 34 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. | | | | | | FDA AUTHORIZES FIRST E-CIGARETTE FOR MARKET — Vuse, a brand owned by tobacco giant R.J. Reynolds, received the first-ever marketing authorization for its Vuse Solo closed e-cigarette device and two tobacco-flavored cartridges, Katherine writes. In its decision, FDA argued that, based on the data the company provided, those e-cigarettes and pods provide a benefit to adult smokers who switch to vaping. “We believe Reynolds has a very strong case to make in an appeal that its products are clearly appropriate for the protection of public health,” said Gregory Conley, the president of the American Vaping Association. “It seems appropriate that the FDA would choose R.J. Reynolds to be the first company to receive a vaping product authorization,” said Gregory Conley, the president of the American Vaping Association. “FDA’s orders confirm that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research dedicated to ensuring that adult nicotine consumers ... have access to innovative and potentially less harmful alternatives to traditional tobacco products,” said a spokesperson for R.J. Reynolds. Anti-youth vaping advocates argue FDA made a glaring mistake authorizing products that are 4.8 percent nicotine — roughly the concentration of products like Juul and Puff Bar, which have a track record of hooking teen vapers. But they are pleased FDA also issued 10 marketing denial orders to Vuse for flavored products. “I think it’s disturbing,” Matthew Myers, the president of the Campaign for Tobacco-Free Kids, told POLITICO. “The tobacco flavor decreases its appeal to youth, but the high level of nicotine increases the risk that a youth who experiments will become addicted. Additionally, they are concerned that Vuse’s popularity with teens as outlined in a recent federal survey will still be a major draw for children. “We’re troubled that a company with Reynolds' history now has the ability to market these products in the United States,” said Erika Sward, the assistant Vice President of National Advocacy at the American Lung Association. “We urge the FDA to monitor R.J. Reynolds’ marketing and whether it makes any claims about its product.” Capitol Hill is also paying attention. Senate Majority Whip Dick Durbin (D-Ill.) tweeted that he remains concerned about “how the agency is applying its risk framework.” And other lawmakers also slammed the agency Tuesday. “FDA has turned its back on the public health by approving a high-nicotine e-cigarette," Rep. Raja Krishnamoorthi (D-Ill.) said in a statement. "Many countries around the world have capped the amount of nicotine allowed in e-cigarettes, which allowed them to avoid a youth vaping epidemic." “While I am pleased that FDA denied requests by the manufacturer to market certain flavors, I remain concerned given this product’s popularity with youth,” Rep. Frank Pallone (D-N.J.), the chairman of the Energy and Commerce Committee, said in a statement. FDA TAKES BACK ORDERS TO REMOVE SOME E-CIGARETTES OFF THE MARKET — The agency rescinded the marketing denial orders it issued Turning Point Brands, a Kentucky-based e-cigarette manufacturer, on Friday, citing critical data in the application it had overlooked. This move places hundreds of the company’s e-cigarette products back in the review process. Although they don’t have marketing orders just yet, FDA also stated it won’t stop Turning Point Brands from selling them. Turning Point Brands was the first company to appeal FDA’s marketing denial orders. Since it did, at least nine other companies followed suit. Although this could have been an isolated misstep from FDA, it could lead to many more vape manufacturers challenging FDA’s decision, said Desmond Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law who focuses on commercial tobacco policy. | | | |   | | | | | | J&J SUGGESTS DIFFERENT BOOSTER INTERVALS BASED ON RISK — FDA on Tuesday posted most of the briefing documents expected ahead of this week’s double-header on booster shots. While we anxiously await the agency’s review of Johnson & Johnson’s booster data, here’s what we do know: The agency is keeping its powder dry on Moderna, and J&J is proposing a booster interval that likely won’t help the confusion already plaguing the Pfizer rollout. Moderna: The documents don’t tell us much we didn’t already know. The company argued the equivalent of a half-dose of its vaccine induces a comparable immune response to a full 100-microgram dose while limiting the chances of adverse side effects. FDA didn’t take a position on booster dosing in its review. J&J: The company’s materials show it’s proposing varied boosting intervals depending on a person’s risk level — two months after the initial shot for those in high-risk occupations like health care or the severely immunocompromised and at least six months for everyone else. Pros may recall that J&J’s booster data, revealed last month, didn’t specify timing for the shots, other than noting they were tested at two- and six-month intervals. J&J also made clear that it still sees its Covid vaccine as the world’s single-shot response to the pandemic, seemingly preempting any talk of refashioning it into a multi-dose series. "In the early stages of a pandemic, a single dose vaccine is an efficient tool to rapidly increase vaccine uptake and reduce the burden on health care systems by preventing severe disease outcomes, especially where supply limitations were present," it said while noting the current stage may warrant different considerations. Schedule recap: The advisory committee will vote on Moderna’s booster application Thursday, while J&J’s will be considered Friday. The second day will also include a presentation of data from the government’s “mix-and-match” booster study, which aims to answer whether people can safely get Covid booster doses from a manufacturer that didn’t make their initial series of shots. CDC advisers set schedule : Centers for Disease Control and Prevention’s independent advisory panel has set its own schedule for considering boosters, as well as meeting on immunizing kids ages 5 to 11 with the Pfizer-BioNTech vaccine. FDA TO DISTILLERS: IT’S THE END OF THE BOTTLE (OF HAND SANITIZER) — The days of artisanal hand sanitizer are numbered as traditional suppliers get plenty of product onto store shelves. FDA withdrew temporary guidance on Tuesday that allowed distilleries and other atypical manufacturers to produce alcohol-based sanitizer for the pandemic, POLITICO’s Sarah Owermohle writes. Producers must either stop making it by the year’s end or adopt higher standards and register as antiseptic manufacturers, which would subject them to user fees. BIDEN TESTING ACTIONS RACE AGAINST WINTER DEMAND — The White House’s estimate that the nation’s supply of at-home Covid-19 tests will triple by early November is not adequate to meet demand, public health experts worry. Demand for at-home tests is expected to soar this fall and winter as the Biden administration finalizes regulations that would require companies with more than 100 workers to ensure any unvaccinated employees undergo testing at least weekly. Increased travel for the holidays, more school screening and the expected return of the flu are also set to pump up demand for at-home tests. Some industry executives argue it will be necessary to tap unused testing capacity at laboratories across the country to augment the limited supply of over-the-counter rapid tests that can return results within minutes. “Around the time of the global Covid summit, there was talk that after the antigen testing, the administration was going to get engaged in making sure that lab capacity was being adequately supported and used,” said Mayo Clinic Laboratories President William Morice, who also serves as president of the American Clinical Laboratory Association board of directors. “But we haven’t had any follow-up from the administration whatsoever.” OSHA VAX RULE HITS OMB — The Labor Department has sent regulations that would require private businesses employing 100 or more workers to ensure their workers are fully vaccinated or tested weekly for Covid-19 to the Office of Management and Budget, according to a department spokesperson. Once the rule clears OMB, which can take days or weeks, it will be released publicly. | | | | 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. | | | | | | | | PUBLIC CITIZEN: DON’T NOMINATE BIO CHIEF AS FDA COMMISSIONER — Consumer advocacy group Public Citizen alongside 25 other groups called on Biden in a Tuesday letter to not nominate Biotechnology Innovation Organization CEO Michelle McMurry-Heath for FDA commissioner. “The next FDA Commissioner must be someone who has been dedicated to advancing public health and unquestionably will place the public interest ahead of the interests of FDA-regulated industries,” the letter states. BOOZ ALLEN OFFERS RECS TO FDA TO BOOST COVID DX RESPONSE — A new report from Booz Allen Hamilton suggests FDA should develop a plan to track staff resources during public health emergencies, improve its IT system to track emergency use authorization processes and develop a framework for validation of diagnostic tests for future emerging pathogens. “The FDA agrees with the priority recommendations identified by Booz Allen Hamilton in their independent assessment of our COVID-19 response,” FDA device chief Jeff Shuren said in a statement. “We will continue to take a flexible approach to COVID-19 tests to meet public health needs and increase access to testing for consumers, including at-home diagnostic tests, which remain a top priority for the agency, that is grounded in sound science.” | | | U.S. TASK FORCE: DON’T ROUTINELY PRESCRIBE DAILY ASPIRIN TO MOST PEOPLE — The U.S. Preventive Services Task Force on Tuesday issued draft guidelines recommending doctors no longer prescribe low-dose aspirin for primary prevention of heart attack or stroke for adults 60 years or older. Adults ages 40–59 not at increased bleeding risk and who have at least a 10 percent chance of developing cardiovascular disease in the next decade may have a small net benefit, and daily aspirin use should be an individual decision. | | | WHO PUTS KRATOM UNDER THE MICROSCOPE — The World Health Organization meeting this week could determine the fate of kratom, a botanical that some advocates say shows promise as an opioid alternative, Lauren reports. Those claims have yet to be fully vetted by scientists, but kratom supporters say FDA’s long-held interest in restricting the substance could curb further research and push users onto opioids, the dangers of which are well understood. | | | Paul Stoffels, Johnson & Johnson’s chief scientific officer and vice chairman of its Executive Committee, will retire at the end of the year. iRhythm announced Karen Ling is joining its board of directors on November 1. Raymond Scott will retire from the board effective the same day. | | | | 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. | | | | | | | | Merck has asked FDA to authorize the emergency use of an antiviral pill that may reduce the risk of severe Covid-19 in some patients, POLITICO’s Adriel Bettelheim writes. Early research shows a generic drug that treats heart failure and swelling because of high blood pressure could treat Alzheimer’s disease, Megan Molteni writes for STAT. | | 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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