FDA ponders Covid booster future

Presented by the Coalition for Affordable Prescription Drugs (CAPD): Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Apr 05, 2022 View in browser   By Lauren Gardner, David Lim and Katherine Ellen Foley Presented by the Coalition for Affordable Prescription Drugs (CAPD) On Tap — The annual process by which flu strains are chosen for vaccines could inform how Covid-19 vaccines are made in the future. But FDA cautions against an apples-to-apples comparison of the viruses ahead of Wednesday's booster meeting. — The Senate HELP Committee kicks off a hearing today to evaluate negotiated frameworks between industry and FDA to reauthorize user fee programs. — A bipartisan deal clinched by senators would steer $10 billion to Covid relief efforts, though none would go abroad. It's Tuesday. Welcome back to Prescription Pulse. Looks like one of your morning hosts accidentally became locally Instagram famous on Monday. Send tips and feedback to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). A message from the Coalition for Affordable Prescription Drugs (CAPD): A new report finds that rebates do not result in higher drug prices. This new data offers clear evidence refuting drug companies' claims that the rebates PBMs negotiate are to blame for increasing list prices for brand drugs like insulin. Rebates help bring down premiums and out-of-pocket costs for patients. Big Pharma wants Congress to believe rebates are the problem, but don't be fooled: their prices are the problem. Learn more.   Coronavirus FDA OUTLINES BIG-PICTURE QUESTIONS FOR BOOSTER DEBATE — An FDA briefing document released Monday outlines the agency's thinking so far on how to approach Covid-19 vaccine formulations as variants continue to percolate worldwide, Lauren writes. The document was issued ahead of Wednesday's day-long advisory committee meeting on how regulators should approach a booster-shot strategy, including who to prioritize for more doses, in the years ahead. While influenza vaccines offer a model for how health authorities consider the makeup of Covid immunizations, the two-year-old virus has its own quirks that make considering modifications to its composition unique. Unlike the flu, Covid has yet to fall into a seasonal rhythm, meaning global regulators face uncertain windows of time in which to consider and sanction variant-specific vaccines that may not even be manufactured in time to benefit patients before a new strain dominates. The novelty of the virus and its vaccines — including the debut messenger RNA-platformed immunizations — also means FDA can't quickly endorse formula changes without clinical trials, as it's done for variable flu shots. There are also the global implications of one variant circulating widely in a region and not spreading to others (remember Beta?). Would it be worthwhile to develop a strain-specific inoculation in that case, and would there be enough demand for manufacturers to make it? Do you have thoughts on the future of Covid boosters? Contact Lauren. MEDICARE COVERS OTC TESTS — Over-the-counter Covid-19 tests are now available at no upfront cost to Medicare beneficiaries through a national demonstration program, David and Rachael Levy report. The decision to provide eight rapid tests per month during the public health emergency marks the first time the public insurance program for people 65 years or older will cover an over-the-counter product, according to a CMS spokesperson. Tricia Neuman, the executive director for Medicare policy at the Kaiser Family Foundation, said the administration's move could lead to Medicare covering over-the-counter medications or products.   A message from the Coalition for Affordable Prescription Drugs (CAPD):   In Congress SENATE TO SCRUTINIZE USER FEES AGREEMENTS — The Senate HELP Committee is meeting at 10 a.m. EST today to discuss reauthorization of FDA's user fee programs with trade lobbies and The Pew Charitable Trusts. Another user fee hearing after recess where FDA leaders will be invited to testify will be scheduled, according to a senior GOP HELP Committee aide. Here's what to expect today: Chair Patty Murray(D-Wash.) plans to call on Congress to address what she will describe as a lack of regulatory oversight of dietary supplements and cosmetics, according to a committee aide. The senior lawmaker also wants more diverse clinical trials, lower prescription drug costs and an accelerated approval program that "benefits patients." "It should be unthinkable that, after two years when FDA's work has been more important than ever, we would fail to get this done and force the agency to send pink slips," Murray plans to say during her opening remarks. Ranking Member Richard Burr (R-N.C.) will focus his opening remarks on "the importance of accelerating innovation" and how to ensure there is accountability and transparency within the user fee programs. Burr is frustrated there was a delay by industry and FDA reaching an agreement on the medical device user fee program — and the GOP aide declined to comment when asked whether Burr plans to seek changes to the proposed MDUFA framework. "The faster, more predictable, and more accountable the [user fee] programs are, the more patients stand to benefit from life-saving, innovative drugs and devices," Burr plans to say during his opening remarks. "When FDA does not live up to its commitments, patients are the ones who suffer." FIRST IN RxP: BIPARTISAN BILL AIMS TO ONSHORE DRUG MANUFACTURING — Sens. Tom Cotton (R-Ark.) and Tina Smith (D-Minn.) will introduce a bill Tuesday aiming to entice drugmakers to move their operations to the U.S., an issue that's likely to get more attention as Senate HELP leaders eye floor time for their pandemic preparedness measure, S. 3799. Worth noting: Smith sits on the HELP Committee. The legislation would establish a demonstration program within CMS providing preferential treatment — such as through a formulary, lower cost-sharing, rebate waivers or provider bonus payments — to certain U.S.-made drugs and biologics covered by Medicare, Medicaid and CHIP in at least eight states, for a minimum of seven years. It would require pharmaceutical companies to maintain emergency reserves and to have a plan ready in case of breakdowns in the medical supply chain. SENATE CLINCHES COVID FUNDING DEAL — Senators reached a deal Monday on a $10 billion bill to fund Covid relief efforts, setting up passage for as soon as this week, POLITICO's Burgess Everett, Erin Banco and Sarah Ferris report. The compromise reroutes billions in unused money from other coronavirus bills to fund therapeutics, testing and vaccine distribution. However, it doesn't include global pandemic aid sought by Democrats and a handful of Republicans, which could become a sticking point in the House. HHS Secretary Xavier Becerra told POLITICO the money would not last long if signed into law. "It would not be enough to cover our expenses to finish the fiscal year," Becerra said on Monday. States are worried they won't have enough funds to manage Covid: State health officials fear that without adequate funding, they won't be able to develop an effective long-term Covid strategy, POLITICO's Megan Messerly reports.   SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today.     Eye on FDA FDA UPDATES EVUSHELD DOSE, AGAIN — FDA updated its recommended dosing regimen Friday for a prophylactic therapy for adults and some children who are immunocompromised and at high risk for severe complications from Covid-19. Patients who received the original, lower dose should get additional shots of the long-acting antibody cocktail, but at different dosages depending on how long it's been since they had the treatment. Those who received their initial dose more than three months ago should get the doubled dose — 300 mg each of tixagevimab and cilgavimab — authorized for eligible patients, regulators said in an FAQ. People who got their first dose within the last three months can get half that, which was the originally authorized dosage. CAVAZZONION BUDGET PRIORITIES FOR FDA'S DRUG CENTER — Patrizia Cavazzoni, the director of the Center for Drug Evaluation and Research, addressed members of the Alliance for a Stronger FDA, a nonprofit organization, on Monday to discuss the office's top budget priorities of 2023, following President Joe Biden's budget request for FDA released last week. More projects on opioids, post-marketing surveillance : CDER submitted proposals for additional funding for tools to better battle the opioid crisis and to conduct more post-marketing safety surveillance, Cavazzoni said. Other priority areas for the office: Developing therapies for rare diseases, establishing a pregnancy safety working group to monitor pregnant individuals taking prescription drugs and getting a biosimilar regulatory research program off the ground by the time the next user fee cycle kicks in by October. Staffing update: "We are in a slight net loss when it comes to hiring, and this is really reflecting what is going on around us in the broader ecosystem," Cavazzoni said, noting the competition across agencies and in the private sector, as well as staff retirements that had been delayed over the pandemic. However, she said that the Office of New Drugs had a net gain in employees, particularly among medical reviewers, which has been aided by the fact that FDA has begun to hire employees outside of the White Oak, Md., area. "We have started hiring new scientists fully remotely with the understanding that it will stay remote," Cavazzoni said. The move has allowed CDER to cast a wider net when hiring and also will help retain staff, she added. "We are very conscious of the fact that the private sector [is] offering a lot of flexibility when it comes to working remotely," she said. "We need to be able to keep up with that."   STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president's ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.     Pharma Moves Ned Sharpless is stepping down from his role as director of the National Cancer Institute at the end of the month. NCI Principal Deputy Director Douglas Lowy will serve as NCI's acting director upon Sharpless' departure. GSK Consumer Health appoints Rachel Marler as chief customer officer for the U.S. She will be the chief customer officer for Haleon, a consumer health focused company, which will de-merge from GSK in July. HeartFlow has appointed Monica Tellado as its chief financial officer. Quick Hits CDC Director Rochelle Walensky announced plans to reorganize and modernize the agency after criticisms that its responses to the pandemic have been slow and unclear, Lena Sun reports for The Washington Post. Document Drawer Senate Finance Chair Ron Wyden (D-Ore.) sent a letter to Merck's CEO yesterday inquiring about the company's international tax practices. A message from the Coalition for Affordable Prescription Drugs (CAPD): A new report finds that rebates do not result in higher drug prices. As Congress debates how to lower the price of insulin, this new data offers clear evidence refuting drug companies' claims that the rebates PBMs negotiate are to blame for increasing list prices for brand drugs. The report also highlights how rebates keep premiums, deductibles, and out-of-pocket costs lower for millions of Americans. Don't be fooled by Big Pharma: their prices are the problem. Learn more.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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