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Presented by Viatris: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim | Presented by Viatris | With Emily Martin. | | | — FDA hits pause on Emergent’s production of J&J’s Covid-19 vaccine. — CDC scrutinizing blood-clotting reports ahead of Friday ACIP meeting. — At-home Covid-19 tests hit the shelves of a major retail pharmacy. It’s Tuesday, welcome back to Prescription Pulse. Your author is thinking about this XKCD comic explaining how mRNA vaccines work while he waits for his second vaccine. Destroy the orb! As always, send tips to David Lim (dlim@politico.com or @davidalim). | | | | A message from Viatris: No matter where they are in the world, or where they are in life, Viatris is committed to providing patients the quality, affordable medications they need on their journey to better health. Learn more about Viatris. | | | | | | FDA HITS PAUSE ON EMERGENT PLANT — Vaccine contract manufacturer Emergent BioSolutions told investors Monday that the FDA told it to stop producing vaccine substance for Johnson & Johnson’s shot until officials finish inspecting a plant dogged by production mishaps, POLITICO’s Sarah Owermohle reports. The agency, which made the call on April 16, told the company to quarantine existing stock until FDA staff finish an inspection and deliver their findings, according to a Securities and Exchange Commission filing Emergent released Monday. Inspectors began their assessment on April 12. An earlier production mistake had spoiled 15 million J&J doses. ‘HANDFUL’ OF ADVERSE EVENT REPORTS UNDER SCRUTINY — Federal health officials are examining new reports of adverse events that may be linked to J&J’s vaccine, ahead of a Friday meeting of the CDC’s vaccine advisory panel. The Biden administration last week recommended a pause in the use of J&J’s shot while it examines a potential link to rare and severe blood clots in vaccine recipients. “There have been a handful of cases, not an overwhelming number of cases,” CDC Director Rochelle Walensky said Monday. “We are working through and adjudicating them and verifying whether they do in fact reflect a true case.” But the CDC said late Monday that “no additional cases of the rare form of blood clots” have yet been confirmed. “If any additional cases are found in safety surveillance, data will be reported to ACIP at its Friday meeting,” the agency said. It could take two weeks or longer for federal health agencies to gather and analyze enough data to determine conclusively whether there is a link between Johnson & Johnson’s coronavirus vaccine and reports of rare but severe blood clots in recipients, according to two senior administration health officials. The data gap may not be resolved before the CDC advisory committee meeting on Friday, report Erin Banco, Dan Goldberg, Rachel Roubein and Sarah Owermohle. One likely scenario is that the panel, and Biden officials, will decide to issue a stronger warning this week about potential risks -- or restrict eligibility -- while pledging to continue studying the matter. NIH PLANS TRIAL OF REPURPOSED DRUGS — The National Institutes of Health said Monday that it will conduct a $155 million clinical trial with 13,500 participants to explore whether up to seven FDA-approved drugs can be repurposed to treat mild to moderate Covid-19 infections at home. Once the list of drugs being studied is finalized, placebos and treatments will be mailed to trial participants. NIH said its goal is to enroll people in communities that are disproportionately affected by Covid-19 but do not have access to an academic medical center where studies are typically run. CVS NOW SELLING AT-HOME COVID TESTS — The drugstore chain is offering at-home Covid-19 tests made by Abbott and Ellume over the counter at several of its retail pharmacies and online. The chain is selling Ellume’s single-use, at-home test for $39 at select locations in Rhode Island and Massachusetts initially before rolling it out to most locations in May. Abbott’s BinaxNOW at-home test is available online and at CVS 5,600 stores as a $24 two-pack serial test that is intended to be repeated twice over three days. Michael Mina, an epidemiologist at Harvard University, described the availability of at-home tests as a step forward for the U.S., but argued more market competition is necessary to bring prices down to acceptable levels. “It is not too late for these to be helpful to many many people,” Mina said. “I just hope that in the next pandemic this happens in month 4, not 14.” | | | | SUBSCRIBE TO “THE RECAST” TO JOIN AN IMPORTANT CONVERSATION : Power dynamics are changing in Washington and across the country. More people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. Our twice-weekly newsletter “The Recast” breaks down how race and identity shape politics and policy in America, and we are recasting how we report on it. 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. | | | | | | | | FDA POSTS MINUTES FROM MARCH MDUFA V NEGOTIATIONS — The FDA on Monday posted its summary of the second user fee negotiation meeting between the agency and the medical device industry. Topics of conversation included increasing engagement with insurers, utilization of real-world evidence, investing in digital health, diversity in clinical trials, and medical device safety surveillance. FDA and industry disagreed over if the agency met its deficiency letter commitments under the last round of user fees and what constitutes an appropriate amount of device user fees. “Specifically, FDA noted, the stark contrast between the level of funding for the drug and device programs has raised external questions of what more FDA could achieve with the medical device program if it was resourced at levels comparable to the drugs program,” the agency minutes state. | | | |   | | | | | | KFF: TOP PRESCRIPTION DRUGS ACCOUNT FOR MOST MEDICARE SPENDING — A new analysis from the Kaiser Family Foundation found that, in 2019, the top 250 Part D prescription drugs with one manufacturer and no generic or biosimilar competition made up 60 percent of spending on the drug benefit. The top 50 in Part B made up 80 percent of spending on that benefit. “Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors,” the report states. | | | Tuesday: Johnson & Johnson holds its earnings call at 8:30 a.m. EST. The Medical Device Innovation Consortium holds a forum on real-world evidence standards. Wednesday: Roche holds its first quarter sales call at 1 a.m. EST. | | | | CHECK OUT FDA TODAY: Daily regulatory developments, sent directly to your inbox. AgencyIQ's daily newsletter, FDA Today, provides readers with actionable and insightful explanations of the latest FDA developments impacting the life sciences industry. Sign up for free today. | | | | | | | | EU UPS PFIZER ORDER TO 600M DOSES — The European Union has inked a deal for 100 million more doses of the Pfizer vaccine, covering two-thirds of the bloc’s population, POLITICO EU’s Carlo Martuscelli reports. The European Commission was able to order additional doses due to an option allowing additional orders baked into the original February purchasing agreement. The commission is also in talks to buy another 1.8 billion coronavirus vaccine doses from Pfizer for distribution between 2021-23 in the event that booster shots are needed to protect against virus variants. EU RETHINKS ITS DRUG DEPENDENCE ON CHINA — Brussels may soon re-evaluate the EU bloc’s reliance on cheaply manufactured generic drugs from the now-number one drug manufacturer, China, Martuscelli reports. Cutthroat pricing is the number one reason Asia became prominent in the pharmaceutical supply chain for generic drugs, whereas decades ago, Europe held that spot. Now, Europe-based companies are more of an important source of pharmaceutical innovation and manufacturing for newer branded drugs. That dominance of the supply chain for medicine in the EU by China, considered a political rival, and the heightened awareness of that dominance pushed by the pandemic, has caused officials to start to explore ways to halt any threat of disruption. | | | Former Housing and Urban Development Secretary Ben Carson is now consulting for Galectin Therapeutics. | | | | A message from Viatris: VIATRIS™ is a new kind of healthcare company, committed to providing access to medicines by tackling policy barriers to healthier lives, building on our unique capabilities to advance holistic health solutions, and working with key stakeholders to achieve better health in the communities we serve. Formed in 2020 through the combination of Mylan and Upjohn, Viatris brings together best-in-class scientific, manufacturing and distribution expertise with a future-focused commitment to policy solutions to deliver quality medicines to patients when and where they need them. Securing stable access to medicine for current and future patients can only be achieved through policy dialogue and collaboration. We are committed to bridging traditional divides in search of solutions. Learn more at Viatris.com. | | | | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. Diabetes treatment gets thumbs-up from FDA committee: An FDA advisory committee last week voted in favor of approving donislecel, a cellular therapy derived from donated islet cells, for the treatment of some patients with brittle Type 1 diabetes. The committee voted 12-4 that donislecel had an overall favorable benefit-risk profile despite lingering concerns about significant side effects, the design of the clinical study used to support the application for approval, and methods of ensuring product identity. Committee members said the therapy may be helpful for a small number of patients. While the FDA often takes the opinion of advisory committees into consideration, it is not bound by their recommendations. AgencyIQ has a full analysis of the meeting available here. A little spring cleaning: Last week the FDA announced the publication of a final rule that makes changes to eight existing regulations in order to bring them into compliance with the 21st Century Cures Act of 2016. The Cures Act had previously exempted seven types of devices from FDA oversight, such as electronic health records and devices that display clinical test data. FDA’s new rule updates some of the agency’s device-specific classifications (of which there are more than 1,000 ) to bring them into compliance with the law. While the net effects of the rule are quite minor since the FDA was already abiding by the law in practice, affected device types include clinical use calculators, continuous glucose monitor (CGM) secondary displays, medical image storage and communication devices, and medical device data systems. | | | China is planning to approve its first foreign Covid-19 vaccine, from BioNTech, before July, as pressure mounts to expand beyond the country’s own roster of shots, The Wall Street Journal reports. The Trump administration promoted the use of a blood plasma of Covid-19 survivors as a potential treatment for those currently infected, but by the end of 2020, hard evidence for its efficacy had not materialized, prompting many prestigious medical centers to quietly abandon it, The New York Times reports. | | | Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) are asking the Accredited Standards Committee to finalize its recommendation that Medicare include device identifiers on its claims forms. FDA on Friday revoked the emergency use authorization for Eli Lilly’s Covid-19 therapeutic bamlanivimab, when it is administered alone, POLITICO’s Darius Tahir reports. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
