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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Sarah Owermohle | With David Lim, Brianna Ehley, Emily Martin and Maura Turcotte | | | — Anthony Fauci weighs in: Covid news in the Biden is era comes with "refreshing" transparency. — Wanted: An FDA commissioner as ambitious Biden vaccine goals are touted. — President Joe Biden looks to the Defense Production Act to beef up the national supply chain. It’s Friday, welcome back to Prescription Pulse. Somehow this shortened week has still been a long one. As always, send tips to Sarah Owermohle at sowermohle@politico.com or @owermohle. Loop in David Lim (dlim@politico.com or @davidalim) and Brianna Ehley (behley@politico.com or @briannaehley). | | | | A NEW YEAR, A NEW WASHINGTON, A NEW PLAYBOOK TEAM: Ryan Lizza, Tara Palmeri, Eugene Daniels and Rachael Bade take the reins of Playbook this week to set the agenda for the political day and days ahead; break news and make sense of it; and provide a steady dose of insider nuggets and intrigue for and about the power players in Washington. Delivered to your inbox twice a day, POLITICO Playbook keeps you up to speed with everything happening in the world of politics as a new administration enters the White House. Subscribe today to the unofficial guide for official Washington. | | | | | | | | COVID NEWS IN THE BIDEN ERA: A ‘REFRESHING’ TRANSPARENCY — The nation’s top infectious disease expert, Anthony Fauci, was the first Biden administration health official to take to the White House press briefing stage, pledging Thursday that the new president would meet ambitious goals on vaccinating millions of Americans — and expressing relief for the new normal. “It’s obviously a very different situation. It's complete transparency,” the nearly four-decade head of the National Institute of Allergy and Infectious Diseases, who has now served under seven presidents, told POLITICO before the briefing . “Nobody is telling you what to say, at all. They are just saying go out there and let the data guide you on what you are saying. It is quite a refreshing experience.” ...Biden says he wants to vaccinate 100 million Americans in his first 100 days, though he and top officials have tempered expectations in recent days. Biden says it will take moving “heaven and earth”; officials say that they are starting from scratch, despite a Trump administration plan that has distributed more than 30 million shots so far. But Fauci is confident. “If you look at what General [Gustave] Perna, is telling us about what’s going to be coming in in the next three months, I believe we are going to make that goal,” said Fauci, referencing the chief operating officer of the national distribution effort, known in the Trump era as Operation Warp Speed. And trying to reinstall global norms. The longtime scientist told POLITICO that he also sees his role as repairing some international relations left in tatters after the Trump presidency. “When you deal with a global pandemic, you have to have global connectivity, cooperation, collaboration and solidarity. That was one of the first things that the president wanted to make sure happened,” Fauci said hours after announcing that the U.S. would rejoin the World Health Organization. It couldn’t come at a more critical time. Fauci spoke Thursday of the need for quick vaccinations amid new, more infectious strains of the virus. But what’s next: The Biden administration’s vaccine goals are running up against serious supply constraints: Only two Covid-19 vaccines, from Pfizer/BioNTech and Moderna, are authorized for use. Two more could be online within months, including a single-dose shot from Johnson & Johnson. But those aren’t yet proven safe and effective; the Food and Drug Administration is prepped for a series of crucial reviews. Speaking of... | | | | KEEP UP WITH CONGRESS IN 2021: Tensions remain high on Capitol Hill as we inaugurate a new president this week. How are lawmakers planning to move forward after a tumultuous few weeks? How will a new Senate majority impact the legislative agenda? With so much at stake, our new Huddle author Olivia Beavers brings you the most important news and critical insight from Capitol Hill with assists from POLITICO's deeply sourced Congress team. Subscribe to Huddle, the essential guide to understanding Congress. | | | | | WANTED: AN FDA COMMISSIONER — The search for one of the most critical jobs in the Biden administration’s effort to battle the pandemic continues as the new president looks for a “battle-worn” expert to take the mantle at the agency. She might have been there all along. The top name circulated for the job is drug review chief Janet Woodcock, according to a half-dozen people familiar with the deliberations. Woodcock has been at the agency for decades, serving in numerous roles including positions in the commissioner's office, I report with Adam Cancryn and Joanne Kenen. Woodcock is currently serving as the agency’s acting chief as the search continues. That has appeal, especially in a crisis. “An acting FDA commissioner would normally be a worry, because the agency needs a strong, independent leader in this time of crisis and political strife,” said Robert Califf, an Obama administration commissioner. “However, if any acting commissioner can do it, Janet is the person.” The president’s overriding focus on meeting his ambitious inoculation target, along with shoring up a pandemic-battered economy, has led him to focus on filling a series of high-profile health jobs — many at the White House — according to sources in the transition. The FDA job is among a second wave of positions that could take months to move through Senate confirmation. It not necessarily weird that an FDA pick has taken this long, experts say, except that the nation is in a health crisis with critical vaccine and drug decisions on the horizon. “Sooner is better,” on the official nomination, said Bush administration FDA commissioner Mark McClellan. “Sooner is especially better in a public health emergency. We’re not done with this pandemic by any means.”
| | | BIDEN TO USE THE DPA TO RAMP UP VACCINE PRODUCTION — Biden’s national strategy for the pandemic response, released Thursday, includes using the Defense Production Act to beef up the vaccine supply chain. One target: increasing manufacturing of syringes with the ability to extract additional vaccine doses from vials. Biden will also use the DPA to ramp up manufacturing of ingredients needed to scale the production of messenger RNA vaccines, including those produced by Pfizer and Moderna. The 200 page national strategy addresses nearly every aspect of the response, from manufacturing and distribution to ensuring equitable access to vaccines, as well as messaging and public education campaigns to combat vaccine hesitancy. | 
The coronavirus vaccine is administered. | David Goldman/AP Photo | INSURERS COULD BE ON THE HOOK FOR SCHOOL, WORKPLACE SCREENING PROGRAMS — One of the executive orders Biden signed Thursday directs the leaders of the Treasury, Labor and Health and Human Services departments to “clarify group health plans’ and health insurance issuers’ obligations to provide coverage for COVID-19 testing.” A Trump-era policy requires insurers to cover Covid-19 testing — but includes a loophole that allows insurers to avoid paying for tests of some people without symptoms of the disease or a suspected exposure. Requiring insurers to cover school and workplace screening is logical, given the emphasis on that type of testing in Biden's Covid-19 plan, according to Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy. The forthcoming change may also make it easier for the federal government to screen its own employees for the virus. On Wednesday, Biden ordered HHS to develop and submit a testing plan for the federal workforce to Covid-19 response coordinator Jeff Zients. | | | WOODCOCK RECUSES HERSELF FROM SOME COVID DRUG DECISIONS — The FDA's new acting commissioner won't participate in agency decisions on some Covid-19 treatments because of her involvement developing them with the Trump administration's Operation Warp Speed. “To help with the transition, I’ve been asked to continue some work with the therapeutics development effort,” Woodcock wrote Wednesday in an email to FDA staff. “This work will involve government-sponsored research and clinical trials, and other matters that would be appropriate for an FDA employee. I will not be involved in contract discussions or similar matters with individual companies.” ANDERSON, RAZA STEP INTO ACTING FDA LEADERSHIP ROLES — Two longtime FDA career staffers are stepping into acting leadership roles at the agency: Erika Anderson will serve as FDA’s acting deputy commissioner for policy, legislation, and international affairs. Mark Raza will take over as acting chief counsel for FDA. The move comes after the Trump administration intervened in its closing days to name Trump political appointee James Lawrence chief counsel instead of Raza. TRUMP-ERA POLICIES UNDER REVIEW? — Last-minute regulations issued by the Trump administration without the blessing of the FDA may not be around for long. When asked about the future of several Trump regulations, FDA spokesperson Michael Felberbaum told POLITICO the agency is working with the Biden administration “to advance appropriate regulations and policies that are in line with the agency’s public health mission.” Flashback: Trump’s HHS and FDA clashed over numerous issues including animal biotech policy, regulation of laboratory developed tests and five-year term limits for center directors. Some of the actions could be reversed easily, but others could require going to court or engaging in rulemaking before they can be clawed back. | | | — Eli Lilly said it found in a study that its antibody drug can prevent Covid-19 in residents and staff of nursing and long-term care homes, AP News reported. — Industry experts expect the Biden HHS to withdraw controversial Trump-era drug-price rules or make regulatory changes to reduce the rules’ impact, Bloomberg Law reported. — Millions of American seniors are frantically hunting for the coronavirus vaccine they qualify to receive, including enlisting grandchildren and younger family members to make appointments, using online tips on pharmacies with leftover vaccine doses and more, The Washington Post reported. —Two studies, not yet peer-reviewed, found that new variants of the coronavirus may pose challenges to the immune system, despite the vaccine, The New York Times reported. | | | Biden signed executive orders aimed at getting the pandemic under control, including efforts such as invoking the Defense Production Act to increase PPE, test and vaccine production; deploying FEMA to set up 100 community vaccination sites in the next 30 days; and create a public dashboard with real-time data on cases, testing, vaccinations and hospital admissions. FDA issued but then withdrew final rules on tobacco policies, including requirements for premarket tobacco product applications. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
