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Presented by the Partnership for America’s Health Care Future: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Sarah Owermohle and David Lim | Presented by the Partnership for America’s Health Care Future | With Emily Martin | | | — Biden promises AstraZeneca vaccines to other countries but questions follow about their needs. — FDA wants more at-home tests and cleared developers this week to market them. — Opioid epidemic derails FDA commissioner search as Janet Woodcock's sure-fire nomination is now in limbo. It’s Friday, welcome back to Prescription Pulse. As always, send tips to Sarah Owermohle ( sowermohle@politico.com or @owermohle) and David Lim (dlim@politico.com or @davidalim). | | A message from the Partnership for America’s Health Care Future: When it comes to what’s next in health care, let’s build on and improve what’s working where private coverage, Medicare and Medicaid work together to expand access to health coverage and care – not start over with an unaffordable, new government-controlled health insurance system like the public option. Learn more. | | | | | | BIDEN PROMISES AZ VACCINES TO OTHER COUNTRIES — The Biden administration is in talks to send millions of AstraZeneca coronavirus vaccine doses to Mexico and Canada, diverging from earlier pledges to stow the vaccines until all Americans have access. But? Concerns abounded about the administration taking the plunge on sending AstraZeneca’s vaccines to neighboring countries right when Europe is grappling with safety concerns. The bloc’s drug regulator said Thursday that AstraZeneca’s shot is safe and effective despite blood clot concerns. Also — Canadian officials said in a Thursday press briefing that between Pfizer and Moderna doses, they had enough to fully vaccinate a majority of people by September. The country will receive 84 million shots between the two drugmakers according to Major General Dany Fortin, who has led Canada’s Covid-19 vaccine rollout. There are roughly 37 million people in Canada. And: For Mexico, the prospect of sending surplus doses from the U.S. came up in a March 1 meeting between, President Joe Biden and Mexican President Lopez Obrador. The topic of Mexico ramping up its law enforcement presence at the U.S. southern border also came up, according to an individual close to the Mexican president and a senior U.S. administration official. The Biden administration made some references to the conversation in the hours following the official meeting. But White House Press Secretary Jen Psaki said definitively that same day that President Biden would not consider Mexico's public request that the U.S. government share its surplus coronavirus vaccine, because inoculating Americans is a priority. The Biden administration is aiming to ship 2.5 million shots to Mexico and 1.5 million to Canada out of its 7 million "releasable doses," Psaki said. FDA WANTS MORE AT-HOME TESTS — The regulatory agency announced earlier this week it will allow some developers of Covid-19 tests to market their products for repeated use without first studying how well they perform in people without symptoms. But some industry sources are cautioning the slightly more lenient policy is not a major shift and it will take time to determine if it will allow more tests to enter the market. "In light of the evolving science and the administration's interest in facilitating the establishment of testing programs by schools, communities and other locations, and expanding access to at-home tests, we at the FDA are providing additional options for test developers to get authorized screening claims," an FDA official told POLITICO. | | | | JOIN THE CONVERSATION, SUBSCRIBE TO “THE RECAST”: Power dynamics are shifting in Washington, and more people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. “The Recast” is a new twice-weekly newsletter that breaks down how race and identity are recasting politics, policy and power in America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country, and hear from new voices that challenge business as usual. Don’t miss out on this new newsletter, SUBSCRIBE NOW. Thank you to our sponsor, Intel. | | | | | | | | OPIOID EPIDEMIC DERAILS FDA SEARCH — The Biden administration’s search for a Food and Drug Administration Commissioner has dragged on despite calls from former chiefs and public health experts to make a quick pick and bolster the agency. It should not have been this hard, but the process has pitted Biden’s allies in the cancer and drug development worlds against a wave of vocal anti-opioid activists and liberal groups eager to push the president further left, Adam Cancryn reports. What was once seen as the inevitable coronation of longtime FDA regulator Janet Woodcock has stalled amid worries she would face sharp opposition among a handful of Senate Democrats over her handling of the opioid epidemic — and among progressive groups who say she’s too friendly with the pharmaceutical industry. A 37-year veteran of the FDA who spent the past year helping develop Covid-19 vaccines in record time, Woodcock commands widespread respect within the agency and among both Republicans and Democrats on Capitol Hill — but her lengthy track record has come under increasing attack. Dozens of addiction treatment and anti-opioid groups have led the way , zeroing in on her tenure as head of the FDA’s drug division during a period where the opioid crisis grew into a full-blown epidemic. The organizations blame Woodcock for presiding over too many opioid approvals during that era, and for the agency’s failure to rein in drug makers pushing the painkillers — a politically explosive accusation that many FDA experts have rushed to refute, yet that nevertheless has jumped to the Senate.
| | | FDA GIVES FIRST DE NOVO GREEN LIGHT TO COVID-19 TEST — BioFire’s Respiratory Panel 2.1 on Wednesday became the first Covid-19 diagnostic test to garner non-emergency regulatory clearance from the FDA . The company used a medical device regulatory pathway known as a De Novo request. The agency says the action will not impact other tests that are reviewed under FDA’s emergency use authorization program. “While this is the first marketing authorization for a diagnostic test using a traditional premarket review process, we do not expect this to be the last and look forward to working with developers of medical products to move their products through our traditional review pathways,” Acting FDA Commissioner Janet Woodcock said in a statement. | | | |   | | | | | | The Bayh-Dole Coalition and ITIF are holding a webinar next Thursday to discuss government march-in provisions of the Bayh-Dole Act. | | | EU REGULATORS DEEM ASTRAZENECA SHOT SAFE — Several days after most EU countries suspended the use of AstraZeneca’s vaccine over blood clot concerns, the bloc’s medicines regulator concluded the vaccine is safe and effective and its benefits far outweigh the risks, POLITICO EU’s Helen Collis reports. However, while the executive director of the European Medicines Agency deemed the vaccine “not associated with an increase in the overall risk of thromboembolic events or blood clots,” the agency did not definitively rule out a possible link. EMA recommended including the possible risks in the product information and training health care professionals and vaccinated people to spot possible side effects. The agency is also launching additional investigations of the few cases where people who received that jab later developed serious clotting disorders. DELHI DRUGMAKER BEHIND U.K. SHOT SHORTFALL — An expected U.K. shortfall in AstraZeneca vaccine doses in April is largely the result of the Indian government temporarily pausing exports, Collis reports. The CEO of drug manufacturer Serum Institute of India, which will meet only half of the originally promised 10 million dosage order in March, said the delivery hold-up “has nothing to do with the SII.” U.K. officials, however, said the shortfall was complex and not caused by one factory, noting that manufacturers are experiencing issues globally. U.K. AND EU SPAR OVER VACCINE EXPORTS — U.K. foreign secretary Dominic Raab accused the European Commission of “brinksmanship” after it threatened to cut off vaccine exports to countries with higher vaccination rates that do not share their own supplies, POLITICO EU’s Matt Honeycombe-Foster reports. Raab’s comments came after Commission President Ursula von der Leyen called for “reciprocity and proportionality in exports” and threatened to cut off supplies to countries that do not export doses to ensure the bloc gets its “fair share” — a thinly-veiled swipe at the U.K. EU officials have been working to address concerns and criticisms over its slow vaccine rollout, which has repeatedly failed to meet supply targets. Britain has yet to disclose how many doses of any coronavirus vaccine it has exported beyond its borders, although it has committed funding to the global COVAX distribution scheme. | | | | GET DAILY REGULATORY UPDATES STRAIGHT TO YOUR INBOX: AgencyIQ’s daily newsletter, FDA Today, provides actionable and insightful explanations of the latest FDA developments impacting the life sciences industry. Sign up for free today. | | | | | | | | HOSPITAL DONORS GET EARLY ACCESS TO VACCINE — The Baptist Health of South Florida hospital system’s fundraising foundation told donors with at least six-figure contributions that they were eligible for the Covid-19 vaccine when doses were in short supply, POLITICO Pro’s Arek Sarkissian and Matt Dixon report. CEO Alexandra Villoch sent an email to donors after Florida Gov. Ron DeSantis began sending doses to another 173 hospitals on Dec. 23. At least five of those hospitals are affiliated with Baptist Health of South Florida, according to governor’s office records posted online. The email listed eligibility requirements that were in line with recommendations made at the time by the U.S. Centers for Disease Control, but were much less stringent than state guidelines. | | | Merck announced Wednesday chief marketing officer of human health Michael Nally will leave the company at the end of March for a leadership role at another company. Frank Clyburn will be named president of human health and take over both commercial and marketing responsibilities. Illumnia announced Thursday Jay Flatley will step down from the company’s board of directors on May 26. John Thompson will be appointed Illumnia’s new board chair. | | | — Bloomberg Businessweek’s Olivia Carville takes a deep dive into the effort to jumpstart swab manufacturing at Puritan Medical Products early in the pandemic. — Pfizer will stop producing biosimilar products in China and sell a unit in the eastern city of Hangzhou to WuXi Biologics, Reuters reports. — Catalent will scale up manufacturing capacity for Johnson & Johnson’s vaccine at its Italian plant to mitigate concerns about the vaccine supply targets in the EU, Reuters reports. | | | A study published in The Lancet found that elderly patients are more prone to reinfection of Covid-19 versus those under 65 who are less likely to catch the virus again for at least six months after recovering. FDA released its FY2020 Generic Drug User Fee Amendments research report.
| | A message from the Partnership for America’s Health Care Future: A new study finds that the cost of a new government-controlled health insurance system like the public option could increase when the economy is at its worst. In fact, in the event of an economic recession, the long-term cost of the new government health insurance system could balloon by an additional $1.4 trillion, placing an even greater financial burden on working families.
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