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Presented by the Healthcare Distribution Alliance: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Katherine Ellen Foley | Presented by the Healthcare Distribution Alliance | With Leah Nylen and Lauren Morello PROGRAMMING NOTE: Prescription Pulse will not publish from Monday, Aug. 30, through Monday, Sept. 6. We'll be back on Tuesday, Sept. 7. | | | — FDA approves the Pfizer-BioNTech Covid-19 vaccine, raising hopes for vaccine holdouts, mandates and boosters... — … and publishes initial PDUFA commitments in anticipation of the act’s seventh reauthorization. — The FTC’s antitrust trial over Grail and Illumina’s merger begins today after the companies completed the deal last week. It’s Tuesday. Welcome back to Prescription Pulse. We love a good poke at the FDA in The Onion. Be sure to send tips to Katherine Ellen Foley (kfoley@politico.com or @katherineefoley) and David Lim (dlim@politico.com or @davidalim). Lauren’s off this week, so send her relaxing vibes instead. | | A message from the Healthcare Distribution Alliance: America’s healthcare distributors connect 1,400 pharmaceutical manufacturers to more than 180,000 healthcare providers — delivering more than 10 million medicines, vaccines and healthcare products safely, efficiently and reliably every day. Distributors are the logistics experts of healthcare, continuously innovating to increase efficiencies, provide value to the healthcare system, and ultimately support patient health. That’s Health Delivered. | | | | | | FDA APPROVES PFIZER-BIONTECH VACCINE —The Food and Drug Administration marked a pandemic milestone on Monday as it approved the first Covid-19 vaccine for use in adults. Some health experts hope the decision will convince vaccine holdouts to finally get the shot. "If you're one of the millions of Americans who said that they will not get the shot until it has full and final approval of FDA: It has now happened," President Joe Biden said Monday. "The moment you've been waiting for is here." Make way for mandates … Full approval paves the way for more employer and school immunization mandates. Within hours of the announcement Monday, the Pentagon said it would accelerate plans to mandate vaccination for active-duty troops. Universities like the State University of New York system and Louisiana State University, have announced plans for mandates that would be triggered by FDA's full approval of Covid shots. ... But not off-label boosters: The vaccine is being distributed under a provider agreement with CDC that makes it more difficult for providers to prescribe the shot off-label — including as boosters for most adults — ahead of the Biden administration’s planned rollout next month. “Uses outside of the authorization and recommendations raise issues like liability protections, compliance with the CDC provider agreement and reimbursement for administration costs,” the CDC said. The administration has authorized Pfizer boosters for immunocompromised people. And CDC estimates that more than 1.1 million Americans have obtained unauthorized booster shots, as first reported by ABC News. “I hope the federal government empowers physicians to make the best choice for their patients,” said Leana Wen, a physician and visiting professor at George Washington University. “There are going to be people who really want it. Why don’t we allow people to have this choice and then capture data from it?” … or shots for kids under 12: Children aged 12 to 15 can receive Pfizer’s Covid-19 vaccine under emergency use, but younger children should wait until clinical trial data is in next month, acting FDA commissioner Janet Woodcock said. Children “are not just small adults,” she told reporters. “We don't have the proper dose, we don't have the safety data nor do we have all the efficacy data.” Name game: The FDA approval means that the Pfizer vaccine now has a U.S. trade name, Comirnaty, the same as in Europe. It’s a mashup of “community” and “mRNA,” but your authors prefer the brutish elegance of Moderna’s EU trade name: Spikevax. Next step: The CDC’s vaccine advisory committee has rescheduled its next meeting — originally set for today — to Aug. 30. The panel will discuss its updated recommendation for the Pfizer vaccine and is expected to address Covid-19 booster shots. | | | ANTITRUST TRIAL OVER CANCER TEST — Cancer startup Grail says its blood test could revolutionize early cancer detection and save 10,000 lives a year. Standing in the way, it argues, are antitrust prosecutors at the Federal Trade Commission who have challenged the firm’s $7 billion merger with sequencing giant Illumina. The agency takes its case to court today, where it will rely on a novel theory that has seen little prior success, Leah Nylen reports. EU merger regulators are also probing the deal, though Illumina is disputing their authority to do so. The backstory: Grail spun off from Illumina in 2015 to develop a blood test called Galleri to detect 50 types of early-stage cancer using DNA sequencing. It debuted in June but is not yet approved by FDA. The arguments: Illumina CEO Francis deSouza told POLITICO the company is uniquely positioned to help Grail bring its cancer test to market worldwide because of its technical knowledge and history of gaining genetic-disease testing approvals in 140 countries. The FTC argues Illumina’s control over the DNA sequencers that Grail and rivals need gives it an incentive to undermine the development of other cancer tests. That “input foreclosure” theory didn’t work in 2017 when the Justice Department unsuccessfully challenged AT&T’s Time Warner merger or last year when the feds tried to block travel booking giant Sabre’s Farelogix deal. Illumina makes most of its money selling sequencers to competitors, which deSouza says undermine’s the FTC’s theory. But the company offered price cuts and a commitment to provide equal access to its technology. Obama-era and Trump antitrust enforcers accepted several deals with those types of promises, but today’s FTC has rejected all negotiations, he said. What’s next: Illumina completed the Grail merger last week but will hold off integration while legal proceedings are underway. The European Commission opened a separate probe Friday into whether Illumina violated standstill rules. The FTC’s in-house trial is expected to last through October,with a decision early next year. | | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | WHITE HOUSE TO HOUSE DEMS: DRUG PRICE PLAN IS A WINNING ISSUE — In private conversations with lawmakers, Biden administration officials have emphasized the proposal’s popularity to allow Medicare to negotiate prescription drug prices, Laura Barrón-López reports. These efforts are part of an increased effort to reach out to House members as they prepare to vote on the budget resolution that will include the drug price measure amid concerns they don’t yet have the needed votes. FDA PREPS FOR SEVENTH REAUTHORIZATION OF PDUFA — The agency posted its commitment to the next iteration of the Prescription Drug User Fee Act on Monday in anticipation of discussions around the reauthorization for fiscal years 2023 through 2027. This act allows FDA to collect fees from drug companies to make the timely deadlines for the products companies submit for review. The current PDUFA agreement expires in September 2022, and the agency will hold a virtual public meeting to discuss the proposed recommendations on Sept. 28, 2021. | | | ‘YOU ARE NOT A HORSE’ — The agency on Friday again warned the public not to take ivermectin to treat Covid-19. The drug, used commonly as a dewormer in horses, has not been shown effective against the virus, and overdose can be fatal. “You are not a horse. You are not a cow. Seriously, y'all. Stop it,” FDA wrote on its main Twitter account. | | | | Be a Policy Pro. POLITICO Pro has a free policy resource center filled with our best practices on building relationships with state and federal representatives, demonstrating ROI, and influencing policy through digital storytelling. Read our free guides today . | | | | | | | | NYC MANDATES SHOTS FOR TEACHERS — New York City will mandate Covid-19 vaccinations for public school teachers and staff for the upcoming school year, Mayor Bill de Blasio announced Monday morning. The move, first reported by The New York Times, is expected to affect 148,000 city workers. It is the first full-on mandate the city is rolling out as the Delta variant causes a resurgence of the coronavirus in the city, Erin Durkin reports. | | | |   | | | | | | EYE ON ANTIBODIES — The U.K. is starting a countrywide antibody surveillance exercise, the country’s Department of Health and Social Care announced Sunday. The government hopes the results of the research will enable better insight into the immune response to different types of vaccines and virus variants, POLITICO EU’s Matei Rosca reports. Antibody tests can show who may have had a Covid infection in the past. Antibodies can also develop after receiving the Covid vaccine. Up to 8,000 volunteers a day will be sent home-testing kits for Covid-19 antibodies by the U.K. Health Security Agency. Participants will be required to take two tests, one immediately after a positive Covid diagnosis and another one 28 days later to measure the difference in antibody presence over time. | | | Pfizer announced Monday it will acquire Trillium Therapeutics, which makes cancer immunotherapies. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA’s new supply chain board – The FDA’s prescription drug review division plans to launch a new group next month, the Pharmaceutical Supply Chain Governance Board, to serve as a coordinating body with oversight of “major supply chain issues.” The group is meant to respond in part to President Biden’s Executive Order on building resilient supply chains. Unlike the FDA’s Drug Shortages Work Group, which tends to focus on individual product shortages, the Governance Board will instead “coordinate major, complex, and high-impact supply chain issues,” according to FDA’s announcement. The board will launch in September and be led by Jacqueline Corrigan-Curay, the Deputy Director of FDA’s Center for Drug Evaluation and Research (CDER). | | A message from the Healthcare Distribution Alliance: As the backbone of the healthcare ecosystem, HDA members are engaged in COVID-19 response efforts, partnering with the federal, state and local governments to distribute treatments, medical supplies and PPE.
We are the people behind the nation’s largest-ever vaccine rollout, working to make sure vaccines get where they are needed and supporting our pharmacy and provider partners, so they can put shots in arms.
Day in and day out, HDA members are leveraging strong relationships at both ends of the supply chain to direct lifesaving medicines to the frontlines, while continuing to meet the daily healthcare needs of all Americans. Distributors are committed to using their logistics expertise and supply chain relationships in the fight against this global pandemic.
Learn more. | | | | | | Abbott Laboratories shut down Covid rapid-test production and destroyed unused inventory early this summer as demand sagged, The New York Times reports — but with the virus surging, the company is scrambling to fill orders. Community and religious leaders across the country are trying to help people evade Covid-19 mask and vaccine rules, the Associated Press reports. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
