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Presented by the 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 and Sarah Owermohle | Presented by the Pharmaceutical Care Management Association | With Brianna Ehley and Emily Martin. | | | — Biden says all American adults will be eligible to be vaccinated by May 1. — Novavax touts the effectiveness of its Covid-19 vaccine. — FDA scrutinizes its accelerated drug approval program. It’s Tuesday, welcome back to Prescription Pulse. Turns out Transportation Secretary Pete Buttigieg is competing with the rest of us for D.C.’s scarce bicycle stock. As always, send tips to Sarah Owermohle (sowermohle@politico.com or @owermohle) and David Lim (dlim@politico.com or @davidalim). | | | | A message from The 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. | | | | | | BIDEN DIRECTS STATES TO OPEN VACCINE ELIGIBILITY TO ALL ADULTS BY MAY — President Joe Biden in his first primetime address announced he will direct all states, tribes and territories to open Covid-19 vaccine eligibility to all adults by May 1. “Let me be clear, that doesn't mean everyone's going to have that shot immediately,” Biden said. “But it means you’ll be able to get in line.” The goal: Americans may be able to celebrate Independence Day in backyards across the nation with a small group of friends and family. But things could still get worse: New variants could still threaten the country’s efforts to return to some semblance of normal, according to Biden. Greg Armstrong, who directs CDC's advanced molecular detection program, told POLITICO one variant of concern first detected in the United Kingdom is rapidly becoming more prevalent. “We did some preliminary modeling back in January that estimated that that would cross the 50 percent mark sometime in late March or early April,” Armstrong said Tuesday. “And unfortunately, we are on track to do that.” NOVAVAX SAYS ITS COVID VAX IS HIGHLY EFFECTIVE — The Maryland biotech’s coronavirus vaccine is more than 96 percent effective against the original virus and prevents severe Covid-19 illness entirely, the pharmaceutical company announced Thursday. The results stem from a phase III trial in the United Kingdom — a similar U.S. trial is underway. Another mid-stage trial in South Africa, where the strain known as B.1.351 dominates, found the shot is 55.4 percent effective against that variant. The Maryland company has never brought a vaccine to market before but received $1.6 billion from the Trump administration to develop its shot and secure 100 million potential doses. It's still running a 30,000-person U.S. trial, the results of which will be used to file for emergency use authorization from the Food and Drug Administration as soon as next month. Executives have boasted that their technology makes it relatively easy to switch out antigens in the formula to target certain variants or even multiple strains of the virus. The company is “confident in our ability to rapidly adapt to evolving conditions,” Chief Commercial Officer John Trizzino told lawmakers in a House Energy and Commerce subcommittee this month. RACE TO DELIVER COVID SHOTS LEAVES BEHIND PEOPLE WITH DISABILITIES — The decision by more than a dozen states to ignore CDC guidance and open vaccine eligibility by age groups has left millions of Americans with disabilities still waiting for the coveted shot, POLITICO’s Brianna Ehley writes. At least 15 states, as of earlier this week, had not opened eligibility to individuals with high risk conditions, including disabilities, unless they live in nursing homes or assisted living facilities, according to a dashboard maintained by Johns Hopkins University. States say the CDC guidance was difficult to implement and argue it's easier and faster to parcel out vaccine by a patient's age than checking if the person is in one of the priority groups the federal government recommends should get the next shots. Officials also note older Americans have the highest Covid mortality rates. But the contrasting approaches threaten to widen disparities that have already become a hallmark of the pandemic — and could weigh particularly on younger disabled people who live independently and could be at greater risk of serious complications from Covid-19. NURSING HOMES — We’re hosting a private Zoom discussion on March 24 about the future of nursing homes with policy expert Dr. David Grabowski, our health care reporter Rachel Roubein and other engaged readers like yourself. Fill out this form to share your thoughts and request an invite. | | | | SUBSCRIBE TO “THE RECAST” TO JOIN AN IMPORTANT CONVERSATION: Power dynamics are changing. “Influence” is changing. More people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. “The Recast” is our new twice-weekly newsletter that breaks down how race and identity are recasting politics, policy and power in America. And POLITICO is recasting how we report on this crucial intersection, bringing you fresh insights, scoops, dispatches from across the country and new voices that challenge “business as usual.” Don’t miss out on this important new newsletter, SUBSCRIBE NOW. Thank you to our sponsor, Intel. | | | | | | | | FDA TEES UP MEETING ON FAST-APPROVED CANCER DRUGS — The agency will convene its Oncologic Drugs Advisory Committee in late April to discuss six instances when drugs approved for certain cancers under the accelerated pathway did not pan out in clinical benefits. Up for discussion are approvals for Genentech’s Tecentriq for locally advanced or metastatic triple-negative breast cancer; Merck’s Keytruda for certain bladder and gastric cancer; and Bristol Myers’ Squibb’s Opdivo for certain liver cancer. Each of these drugs is part of a relatively new class of therapies that attack cancer by targeting proteins on the tumors, an approach known as immuno-oncology. The results can be promising, especially for cancers with often dire prognoses like lung cancer. Why it matters: Accelerated approval, a way of fast tracking reviews originated during the HIV crisis, has steadily become the pathway for cancer therapies — and not without criticism. A JAMA review last year found that “the FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.” Meanwhile some scientists have argued that those trials are focusing on the wrong thing — a tumor’s response — rather than whether a person’s life is extended with the treatment. "We are committed to ensuring the integrity of the accelerated approval program, which is designed to bring safe and effective drugs to patients with unmet medical needs as quickly as possible,” Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in a statement. FDA will review the approvals for those uses after the April 27 to 29 meeting. ICYMI: EX-COMMISSIONERS WANT PERMANENT FDA HEAD — A bipartisan group of former FDA commissioners is asking Biden to quickly name a permanent leader for the agency, although they stopped short of implicitly petitioning him to elevate acting FDA Commissioner Janet Woodcock. “Experienced leadership of the agency reinforces your commitment to scientific rigor and science led decision making,” Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, Mark McClellan and Andrew von Eschenbach wrote. “Across Democratic and Republican administrations, we have worked closely with Dr. Woodcock across a range of critical issues.” | | | BIDEN ADMIN DELAYS 340B RULE, AGAIN — The administration pushed back implementation of a last-minute Trump rule that would pass drug discounts to patients in a federal program, saying it needed more time for review and comment. Officials propose delaying the policy until at least July 20, 2021. Remember: The original rule, announced by former President Donald Trump with a cluster of drug-pricing orders in July 2020, would require certain 340B facilities like community clinics in underserved areas to give savings from insulin and EpiPen discounts directly to consumers. The regulation applies to roughly 1,000 federally qualified health centers in the program, making it relatively narrow compared to full-scale 340B reforms that Republicans have pushed. Biden had already delayed the move until at least late March as part of a broader regulatory freeze in order to review late-implemented regulations. The National Association of Community Health Centers, representing clinics that would have been impacted by the rule, rejoiced at the time, saying it would have levelled a new administrative burden on providers . “We are deeply grateful the Biden Administration put the brakes on such a harmful rule within hours of taking office.” Biden’s HHS is seeking comment on the delay until July and on any legal or policy concerns. | | | EU FACES DELIVERY DELAYS AFTER APPROVING J&J — On the same day the European Medicines Agency and European Commission approved the Johnson & Johnson vaccine, the American company confirmed that its first deliveries overseas won’t arrive until mid-April at the earliest, POLITICO EU’s Jillian Deutsch reports. Some EU diplomats even expressed concerns that the deliveries may be delayed amid rumors that the doses, put into vials in the U.S., could be halted by the American government. There is immense pressure growing for the Commission to accelerate vaccine efforts as the bloc faces delivery shortages from AstraZeneca, and several countries halt inoculations of AstraZeneca’s vaccine in light of blood clotting concerns. ASTRAZENECA ROLLOUT PAUSED OVER BLOOD CLOTS — Countries across Europe are suspending the rollout of the Oxford/AstraZeneca jab after reports of blood clotting after vaccination, POLITICO EU’s Ashleigh Furlong, Helen Collis and Carlo Martuscelli report. While health authorities have stressed there's no indication of a link between the several deaths and the vaccine, Austria, Denmark, Estonia, Lithuania, Luxembourg, Latvia and Italy, as well as non-EU Norway and Iceland, have all suspended the rollout of some AstraZeneca batches as a precaution. The latest issue with blood clots adds to AstraZeneca’s issues in the EU. The drugmaker has also been in hot water for delivering significantly lower amounts of doses than originally projected. France also stopped general practitioners from putting in any further orders for the AstraZeneca vaccine in a move seen as a punishment for not vaccinating fast enough. France has close to 900,000 unused doses of the jab, according to figures obtained from the health ministry, which will now be prioritized for distribution by chemists. | | | |   | | | | | | NJ NURSING HOME STAFF VACCINE EFFORTS LAG — New Jersey Health Commissioner Judith Persichilli said that roughly half of the workers at nursing homes and long-term care facilities in the state have yet to be vaccinated, POLITICO’s Sam Sutton reports. While 72 percent of long-term care residents and 90 percent of assisted living residents have received their shots about three months after the state kicked off its vaccination program, efforts to inoculate staff have lagged, she said. “Fifty percent of staff at long-term care getting vaccinated is unacceptable,” Gov Phil Murphy said after Persichilli’s remarks. “That number’s gotta change.” | | | ADVAMED OUTLINES 2021 PRIORITIES — Top issues for the medical device lobby include monitoring the Covid-19 supply chain, medical device user fee negotiations and urging the formalization of the Medicare Coverage of Innovative Technology rule, AdvaMed CEO Scott Whitaker told reporters on Thursday. “Our expectation is that [the MCIT rule] moves forward,” Whitaker said. “Exactly how it will be implemented, and how the regulations and coverage decisions will roll out is the conversation we'll have with CMS once we've reached March 15.” Janet Trunzo, AdvaMed’s senior executive vice president of technology and regulatory affairs, said the device trade group is waiting to hear how FDA will spend $500 million in new funds from the newly signed American Rescue Plan. WALENSKY WANTS REOPENING BUSINESSES TO CONSIDER EMPLOYEE TESTING — As Americans head back to work in larger numbers, businesses should conduct daily health checks, implement physical distancing measures, encourage mask wearing and provide hand hygiene supplies, CDC Director Rochelle Walensky told virtual attendees of the American Clinical Laboratory Association’s annual meeting on Thursday. “We urge our employers to consider incorporating testing for SARS-Cov-2 into workplace preparedness, response and control plans,” she said. | | | | FIND OUT THE LATEST WHISPERS FROM THE WEST WING: Add Transition Playbook to your daily reads to find out what's really happening inside the West Wing, who really has the president's ear, and get the latest scoop from inside cabinet departments and agencies. Track the people, policies and emerging power centers of the Biden administration. Don’t miss out. Subscribe today. | | | | | | | | The House Energy & Commerce Oversight Subcommittee is holding a hearing on Covid-19 vaccination progress March 17 at 10 a.m. NIH’s Anthony Fauci, CDC Director Rochelle Walensky and FDA vaccine regulator Peter Marks are scheduled to testify. | | | Moderna announced on Wednesday that Elizabeth Nabel is rejoining its board of directors. She stepped down from the position in July 2020 because of her job at Brigham and Women’s Hospital, one of the clinical trial sites for Moderna’s Covid-19 vaccine. Biden announced Thursday he intends to nominate Melanie Egorin to be HHS’ assistant secretary for legislation. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. — The American Rescue Plan signed into law yesterday contains $500M in direct funding for the FDA with few strings attached regarding how it is to be spent, according to a review of the legislation by AgencyIQ. The text of the legislation states that the funds should be used for reviewing the continued performance of authorized COVID-19 products, advanced manufacturing, facility inspections, oversight of the supply chain, addressing product shortages and the review of devices approved, cleared or authorized for use for COVID-19. — The FDA is working to launch a system to allow the real-time tracking of medical device submissions, which in theory would allow companies to monitor the status of their applications – including delays – in the same way that you can now monitor package deliveries. The effort was required by the FDA Reauthorization Act of 2017 but has been subject to delays. This month, FDA is seeking 100 companies to help it pilot the new system and provide feedback. | | | | A message from The 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. | | | | | | An FDA inspection report found that Pfizer’s management knew last year there was a mold issue at the Kansas facility now slated to produce the drugmaker’s Covid-19 vaccine, Kaiser Health News reports. White House Coronavirus Response Coordinator Jeff Zients and Chief Scientific Officer David Kessler worked together to nudge Johnson & Johnson and Merck past a logjam to ink their deal to speed up vaccine output, Bloomberg News reports. BioNTech said it may have the capacity to supply 3 billion more doses of the vaccine it partnered with Pfizer to create by 2022, Bloomberg News reports. A former human resources employee at a Eli Lilly factory alleged that she was fired after discovering files with complaints about manufacturing problems were taken from her desk, Reuters reports. Alaska became the first state to remove eligibility requirements for the coronavirus vaccine, making immunization available to residents aged 16 and older, The Washington Post reports. | | | FDA is soliciting public comment on the proposed collection of information associated with prescription drug marketing.
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