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Presented by Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim | Presented by Pharmaceutical Care Management Association | With Lauren Morello, Sarah Owermohle and Alice Miranda Ollstein. | | | — Novavax becomes the latest vaccine maker to study its coronavirus shot in teens. — House Democrats ramp up drug pricing pressure on Biden. — The newest MACPAC members are unveiled. It’s Tuesday, welcome back to Prescription Pulse. John Oliver is the latest to take a look at the U.S. vaccination campaign. As always, send tips to David Lim ( dlim@politico.com or @davidalim). | | | | A message from Pharmaceutical Care Management Association: The Biden Administration postponed the effective date for the Medicare rebate rule until 2023. Despite the delay, uncertainty remains. The cleanest path forward to avoid disruption to Part D, caused by jarring monthly premium increases, is for Congress to quickly repeal the rebate rule outright. | | | | | | VACCINES FOR TEENS — Vaccine developer Novavax said Monday it has begun a clinical trial of its coronavirus shot in adolescents ages 12 to 17. Up to 3,000 kids will be enrolled in the trial, which is starting as the company finishes up its late-stage U.S. study in adults. Novavax is expected to ask FDA to authorize its vaccine for adults in the coming weeks. In the meantime, all eyes are on Pfizer and BioNTech, whose vaccine could be the first allowed for this age group in the U.S. The two companies asked FDA last month to authorize their shot for 12- to 15-year-olds, and the agency is expected to act any day now. The European Medicines Agency said Monday that it is also examining whether to allow the shot for 12- to 15-year-olds and expects to make a decision next month, POLITICO EU’s Jillian Deutsch reports. FEDS RETHINK VACCINATION STRATEGY — As more cities and counties with robust Covid vaccination rates start to experience stirrings of post-pandemic life, some communities just a short drive away are seeing the opposite: paltry demand for shots accompanied by new hot spots of disease. Now the Biden administration is redoubling its efforts to reach the stragglers, Dan Goldberg and Adam Cancryn report. The administration is pivoting away from mass vaccination sites to refrigerated vans, community health clinics and even door-to-door campaigns in predominantly rural communities with the most holdouts. “The ground game really matters now,” a senior administration official said. “We don’t have to do these major FEMA sites.” BIDEN ADMIN STRUGGLES ON VACCINE AID — The Biden administration’s recent decision to send coronavirus vaccines to India has created tensions with another key ally: Ukraine, which has ramped up its requests for vaccine aid ahead of a visit this week from Secretary of State Antony Blinken. Ukrainian President Volodymyr Zelensky’s administration has pressed Washington to obtain vaccines since December, according to multiple U.S. and Ukrainian officials. The conversations have continued in recent weeks at the diplomatic level, and officials said the pandemic — and Ukraine’s hope for U.S. assistance — was a backdrop for a 50-minute phone call between Zelensky and President Joe Biden on April 2, Erin Banco and David Herszenhorn report. The Biden administration is eager to step up its international vaccine aid as a counter to China and Russia. But U.S. officials have yet to commit specific assistance to Kyiv because they have not figured out how to prioritize the overwhelming number of requests they have received from multiple countries, according to two Biden administration officials familiar with the matter. | | | | SUBSCRIBE TO "THE RECAST" TODAY: Power is shifting in Washington and in communities across the country. More people are demanding a seat at the table, insisting that politics is personal and not all policy is equitable. The Recast is a twice-weekly newsletter that explores the changing power dynamics in Washington and breaks down how race and identity are recasting politics and policy in America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear critical new voices that challenge business as usual. Don't miss out, SUBSCRIBE . Thank you to our sponsor, Intel. | | | | | | | | HOUSE DEMS AIM TO FORCE BIDEN’S HAND ON DRUG PRICING — The House Energy and Commerce Committee will hold a hearing today on several bills aimed at tackling high drug costs, including leadership’s sweeping legislation, H.R. 3 (117) , that would empower Medicare to bargain down the cost of hundreds of drugs, Alice Miranda Ollstein reports. The hearing, followed Wednesday by another in the House Education and Labor committee, comes as Democrats aim to ramp up pressure on Biden to include some form of drug price negotiation in his sprawling infrastructure plan. "H.R. 3 provides the reforms we need to lower the cost of prescription drugs and uses some of the savings to reinvest in efforts to find the next scientific breakthroughs at the National Institutes of Health and improve drug review at the Food and Drug Administration," E&C Chair Frank Pallone (D-N.J.) will say, according to opening remarks shared with POLITICO. Some Democrats want to use the money to expand Medicare. Aware that the package may be the last Congress is able to pass this year, Democrats in the House and Senate are fighting to have their top health policy priorities included, and are warning the White House that a failure to address high drug prices will drag the party down in the 2022 midterms. MARSHALL, SMITH, CASSIDY INTRO EUA DATA BILL — A new bill introduced by Sens. Roger Marshall (R-Kan.) Tina Smith (D-Minn.) and Bill Cassidy (R-La.) would allow the FDA to create a framework to explain how real-world evidence from medical products on the market under an emergency use authorization can be used to support premarket applications. | | | FDA PREPARES FOR PDUFA PROGRAM FEE INVOICES — The FDA announced Monday it will issue FY 2022 program fee invoices for Prescription Drug User Fee Act fee-eligible products in August. The agency is asking companies to confirm or correct contact information and to list fee-eligible products by June 1. ANOTHER ONE BITES THE DUST — The FDA on Friday withdrew a last-minute Trump administration policy requiring the agency to annually report its drug review timelines. The notice was part of a string of late policies HHS issued in January. Trump officials at the time said the plan would ensure FDA met its review deadlines, but they swiftly drew criticism from FDA staff surprised by the move and former commissioner Scott Gottlieb, who tweeted that "these midnight actions impact the FDA’s public health mission." | | | | A message from Pharmaceutical Care Management Association:   | | | | | | DODARO ANNOUNCES NEW MACPAC MEMBERS — Comptroller General Gene Dodaro announced Monday five members of the Medicaid and CHIP Payment and Access Commission. Heidi Allen, Robert Duncan, Laura Herrera Scott and Verlon Johnson have been appointed to serve until April 2024 and Dennis Heaphy until April 2022. | | | MYRIAD SPINS OFF VECTRA TO LABCORP — Genetic testing company Myriad Genetics announced Monday it signed an agreement to sell certain assets and IP — including rheumatoid arthritis disease test Vectra — to LabCorp for $150 million. The deal is expected to close by the end of the third quarter. “While we are strong believers in the future growth prospects for Vectra, this divestiture will allow us to increase operational focus and better execute in our core strategic businesses of Women’s Health, Oncology, and Mental Health,” Myriad Genetics CEO Paul Diaz said in a statement. | | | | TUNE IN TO GLOBAL TRANSLATIONS: Our Global Translations podcast, presented by Citi, examines the long-term costs of the short-term thinking that drives many political and business decisions. The world has long been beset by big problems that defy political boundaries, and these issues have exploded over the past year amid a global pandemic. This podcast helps to identify and understand the impediments to smart policymaking. Subscribe and start listening today. | | | | | | | | Tuesday: CVS Health holds its first-quarter earnings call at 8 a.m. EST. Pfizer holds its first-quarter earnings call at 10 a.m. EST. FDA holds a virtual meeting to discuss patient-generated health data from medical devices at 10 a.m. EST. The House Energy and Commerce health subcommittee holds a hearing on legislation to lower the cost of prescription drugs at 11:30 a.m. | | | WHO TO DECIDE ON VACCINES FROM CHINA THIS WEEK — The World Health Organization will finalize its assessment of two vaccines developed by China’s Sinopharm and Sinovac for emergency use listing by the end of this week, Mariangela Simao, WHO’s assistant director-general for access to medicines and health products, told reporters Monday. WHO gave an emergency-use listing on Friday to Moderna, making it the fourth to get the organization’s green light. DENMARK HALTS USE OF J&J VACCINE — Denmark decided Monday that it will stop using the Johnson & Johnson vaccine, according to an announcement seen by our POLITICO colleagues in Brussels. The government agrees with European regulators that the vaccine is safe and effective despite reports of rare blood-clotting incidents, but “given the current epidemiological situation in Denmark” said it will forego use of the shot, Jillian Deutsch reports. The vaccine is still authorized in Denmark, and the country will maintain its contract for doses. MODERNA PLEDGES DOSES FOR POOR COUNTRIES — Moderna said Monday that it would supply 500 million doses of its coronavirus vaccine to COVAX, a global initiative to supply vaccines to low- and middle-income countries. The company will work with global vaccine alliance GAVI to provide 34 million doses to COVAX later this year at what it called its “lowest tiered price.” GAVI will have the option to purchase another 466 million doses in 2022. EU TAKES ASTRAZENECA TO COURT FOR MORE DOSES — The European Commission is dragging British pharmaceutical giant AstraZeneca into court to demand that the company send vaccine substance from two U.K. sites to the regional bloc. It’s a remarkable move considering AstraZeneca could try to have the case thrown out on the grounds that the contract explicitly says the EU won’t sue over delivery delays. That the Commission has pressed ahead underscores how upset EU officials are over the company's failure to deliver millions of doses — and how negotiations have deteriorated to the point they seem irreparable, Jillian Deutsch writes. The EU says AstraZeneca is now set to deliver just 70 million of 180 million doses promised in the second quarter of the year, on top of supplying only 30 million out of 120 million scheduled by the end of March. (The U.S., meanwhile, has stockpiled more than 60 million doses that it promised last week to send to countries in need). “The purpose is to receive the doses we are entitled to,” Commission spokesperson Stefan De Keersmaecker said. | | | Eagle Pharmaceuticals announced Monday former FDA acting chief scientist Luciana Borio is joining its board of directors. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA, industry start biosimilar negotiations — The FDA last week posted the first readouts from its negotiations with the biosimilar industry to reauthorize the Biosimilar User Fee Amendments (BsUFA). The program, first established in 2012 and renewed in 2017, acts as a sort of bargain between the FDA and life sciences companies. In return for companies paying the FDA a substantial fee each time they submit a biosimilar product for evaluation, the FDA uses the fees to hire new staff and review biosimilars on a certain timeline. In theory, the funding allows biosimilar products to be reviewed more quickly, enabling biosimilar companies to recoup a faster return on their investments in development. According to the meeting minutes posted by the FDA, the two sides are focused on potential improvements to provide more predictable funding for the FDA, more communication between regulators and sponsors during the application review process, and the use of “alternative tools” to complement facility inspections, among other topics. | | | | A message from Pharmaceutical Care Management Association: Medicare beneficiaries appreciate the Biden Administration’s decision to delay the prescription drug rebate rule which would increase Medicare Part D premiums 25% and cost taxpayers $170 billion. Congress and the Administration should now permanently repeal the rebate rule and instead advance real solutions that lower the costs of prescription drugs. | | | | | | Blackouts, fires and pandemic-related demand have created a global shortage of pipette tips that is threatening nearly every corner of the scientific world, Stat reports. CVS and Walgreens have wasted more vaccine doses than states, U.S. territories and federal agencies combined — and tracking the problem could help to identify bottlenecks in distribution, Kaiser Health News reports. Helen Murray Free, a chemist who ushered in a revolution in diagnostic testing when she co-developed the dip-and-read diabetes test, a paper strip that detected glucose in urine, has died at 98, The New York Times reports. | | | HHS is asking for nominations of seven non-federal individuals to serve on The Advisory Council on Alzheimer's Research, Care and Services. The National Clinical Care Commission is virtually meeting on May 19 and June 1 to discuss and make recommendations about federal diabetes programs to HHS and Congress. A group of 36 organizations — including FreedomWorks, Heritage Action for America and Americans for Tax Reform — sent a letter Monday to HHS and FDA leaders asking them to reject any proposed ban on menthol cigarettes or other flavored tobacco products. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
