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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 Lauren Gardner, David Lim and Katherine Ellen Foley | Presented by CVS Health | With help from Megan R. Wilson PROGRAMMING NOTE: We’ll be off for Thanksgiving next Friday but back to our normal schedule on Tuesday, Nov. 30. | | | — FDA is expected to authorize booster shots for all adults today, months after the White House first pushed for them. — The Congressional Budget Office released its estimate laying out how much Democrats’ social spending bill — and its drug pricing measures — will impact the federal deficit. — Legal skirmishes over e-cigarettes and menthol cigarettes are making their way through the courts. It’s Friday. Welcome back to Prescription Pulse. Send your favorite regulatory fun facts about Thanksgiving to us, and we’ll highlight our favorites next week. 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. | | | | | | FDA SET TO AUTHORIZE BOOSTERS FOR ALL ADULTS — FDA is expected to authorize Covid-19 boosters by both Pfizer-BioNTech and Moderna for all adults before noon today when the CDC’s external vaccine advisory panel is scheduled to meet to consider recommending them, POLITICO’s Adam Cancryn scoops. The move comes just days after Moderna filed for authorization. FDA had planned to authorize Pfizer’s booster shot this week, which lets the feds roll out shots to millions more people right before Thanksgiving. But officials began debating whether to speed Moderna’s authorization along once its application came through, people with knowledge of the matter said. But it’s not a done deal that the CDC’s advisers will go along with the FDA, especially since the independent committees were skeptical of widespread boosting two months ago, and the data hasn’t changed much. BUT STATES BEAT THEM TO IT — What began as a wave became a tsunami this week as several states formally — or at least more explicitly than they had — advised adult residents to seek out Covid boosters. At least 11 states across the political spectrum, from blue California to purple Colorado to red West Virginia, are actively promoting booster shots for all adults who are at least six months past their second mRNA dose or two months post-Johnson & Johnson shot. Others are urging residents in high-transmission areas to get them, stating it puts them at higher risk for contracting the virus. West Virginia’s folksy Republican governor, Jim Justice, has urged residents for weeks to get booster shots, insisting that nearly every adult in the state qualifies given how many people suffer from comorbidities that could worsen their cases of Covid. He was more blunt on Wednesday during a pandemic briefing: “In my opinion, if you’re breathing, you can qualify.” States like his usurped FDA and CDC because of the facts on the ground: Cases are rising again after reaching a late-October low point, and they’re increasing from a baseline that’s well above the June nadir. Hospitalizations tend to lag by two to three weeks, and some states have had to activate crisis standards of care, which can be a precursor to rationing care to prioritize those most likely to live. Those running West Virginia’s Covid response say the need to keep hospitals afloat amid stubbornly low vaccination rates and elevated case counts is driving their booster campaign. With more than a quarter of those hospitalized in the state fully vaccinated, they told Lauren during a visit to their headquarters Wednesday they’ve seen for themselves that boosters are necessary. FEDS WILL BUY 10M COURSES OF PFIZER’S COVID-19 PILL — The Biden administration reached an agreement with Pfizer to buy 10 million courses of the company’s antiviral Covid-19 pill through 2022, Katherine reports. The government will pay Pfizer $5.29 billion for the treatment, called Paxlovid, with an expected rollout beginning by the end of the year — pending FDA authorization. Pfizer formally asked the agency for authorization earlier this week. | | | | 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. | | | | | | | | CBO: DRUG PRICE OVERHAUL COVERS SOCIAL SPENDING COSTS — The health care portion of House Democrats’ social spending bill would largely be offset by provisions intended to rein in the cost of prescription drugs and the repeal of a Trump-era drug rebate rule, POLITICO’s Alice Miranda Ollstein writes. The release of the official estimate gave Democratic leadership the bandwidth to set up a vote on the package late Thursday. The Congressional Budget Office’s score pegs the government’s savings at about $300 billion over a decade as a result of policies to negotiate down the cost of some pricey drugs, penalize drug companies that hike prices faster than inflation, redesign seniors’ Medicare benefits and repeal the rebate rule. Measures to expand Obamacare, Medicare, Medicaid and home health care come out to the same amount. HOUSE REPUBLICANS TAKE AIM AT PHARMACY BENEFIT MANAGERS — House Committee on Oversight and Reform Ranking Member James Comer (R-Ky.) held a forum Wednesday with other Republican lawmakers that took aim at pharmacy benefit managers and their role in the drug market, POLITICO’s Megan R. Wilson reports. DIR fees, or direct and indirect remuneration fees, which PBMs charge pharmacies, played a starring role in the hearing. But policymakers and the seven-person panel – featuring just one PBM representative — also discussed spread pricing, industry consolidation and patient steering. Called a "forum" because the minority party is unable to hold official congressional hearings, Comer said Oversight Committee Chairwoman Carolyn Maloney (D-N.Y.) rebuffed his suggestions to have a hearing on PBMs. Comer also promised to issue a corresponding report that will take PBMs to task. Oversight Democrats told POLITICO in a statement: “It is curious that Republicans are focusing on PBMs at the same time Big Pharma is staring down one of the most meaningful checks on its abusive pricing practices in years — Medicare negotiation ... We have found ample evidence that drug companies’ own practices are the primary drivers of skyrocketing drug prices.” Speaking of PBMs: Physician and patient advocates from the Alliance for Transparent & Affordable Prescriptions, which favors more-stringent regulations on PBMs, virtually lobbied the Hill Tuesday on three bills that would require studies on the industry and require insurers and PBMs to pass drug rebates directly to consumers enrolled in certain kinds of insurance plans. | | | | A message from CVS Health: .png "Advertisement Image")  | | | | | | FDA WARNS OF RISK OF CARDIAC PERFORATION COMPLICATIONS DURING LEADLESS PACEMAKER SURGERY — FDA on Wednesday cautioned health care providers that major complications — including death — can result if cardiac perforation happens during implantation of a leadless pacemaker. “The overall risk of cardiac perforation associated with leadless pacemaker implantation appears similar to the risk associated with traditional transvenous pacing systems,” the agency said in its letter to health care providers. “However, the Medtronic Micra leadless pacemaker premarket clinical studies suggested major complications related to cardiac perforation appeared to be more severe for patients who received a leadless pacing system compared to patients who received a transvenous pacemaker. | | | OVER TWO MONTHS OUT, AND NO SIGN OF E-CIG DECISIONS FOR MAJOR PLAYERS — Earlier this week, the six public health groups who initially brought a lawsuit against FDA wrote a letter to District Judge Paul Grimm, asking him to require FDA to provide regular updates on its progress and estimated dates by which it will decide the fate of marketing applications from the top ten companies by market share. Judge Grimm, who serves in the United States District Court for the District of Maryland, ruled in 2019 that FDA had to move up its deadline for companies submitting applications from August 2022 to May 2020 (it was eventually moved to Sept. 2020 because of the pandemic). The groups authoring this letter include the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative. FDA’s deadline to issue marketing orders or denials to e-cigarette companies was Sept. 9; so far, the agency has taken action on more than 98 percent of its applications. It granted two marketing orders to an e-cigarette from Vuse and a discontinued product. It has yet to make decisions on most of the major market players, including Juul. Speaking of Juul …: This week, the North Carolina attorney general Josh Stein announced he is suing James Monsees and Adam Bowen, the company’s founders, for their role in the company’s advertisements to teens. A lawsuit Stein previously brought against Juul for its deceptive practices resulted in the company paying $40 million to the state of North Carolina. He is also launching a statewide investigation into Puff Bar and other e-cigarette manufacturers. … and no word on menthol either: A judge in the district court of Northern California stated Wednesday she would retain jurisdiction over a lawsuit brought against FDA by health organizations, led by African American Tobacco Control Leadership Council, over the lack of menthol cigarette regulation. FDA had asked the case to be dropped because of its announcement that it would propose a menthol rule in April 2022; plaintiffs were hoping to see action sooner. | | | | 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. | | | | | | | | Pfizer’s Frank D’Amelio will retire from his position as chief financial officer and executive vice president of global supply. Mike McDermott, the company’s president of global supply, will take over D’Amelio’s role in the new year. eMed on Thursday hired Michael Mina as the telehealth company’s chief science officer. California-based IGM Biosciences registered its first in-house lobbyist, Andrew Womack — an alum of Genentech and the now-Biotechnology Innovation Organization.
| | | New York City wants its residents to get tested for Covid-19 before traveling for the holidays, POLITICO’s Erin Durkin reports.
| | | The Biden administration will send millions of doses of Johnson & Johnson’s Covid-19 vaccine to the border of Thailand and Myanmar in December, POLITICO’s Erin Banco reports.
| | | CMS announced this week it is proposing to expand its national coverage determination for screening lung cancer with low-dose computed tomography to include younger smokers.
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