Senate HELP lawmakers to release their user fee package

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May 17, 2022 View in browser   By David Lim, Lauren Gardner and Katherine Ellen Foley With help from Sarah Owermohle On Tap — The full House Energy and Commerce Committee will mark up its FDA user fee package on Wednesday. — Top Senate HELP Committee lawmakers plan to debut a discussion draft today that would reauthorize the user fee programs and include reforms of diagnostics, cosmetics and dietary supplements. — The CDC's vaccine advisory committee will meet Thursday and likely discuss the Pfizer-BioNTech Covid-19 booster for children as young as 5. It's Tuesday. Welcome back to Prescription Pulse. The federal government is making a third round of free Covid-19 tests available for ordering as cases creep up yet again. 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). In Congress The reauthorization of FDA's medical product user fee program is among the items in the wide-ranging health legislation slated to be marked up by the E&C Committee on Wednesday. | Sarah Silbiger/Getty Images E&C SCHEDULES FULL COMMITTEE MARKUP — The Energy and Commerce Committee will mark up major health legislation — including reauthorization of FDA's user fee programs and the House's mental health package — Wednesday at 10 a.m. EDT, Chair Frank Pallone (D-N.J.) announced Monday. Advocates are making last-minute pushes: Lobbying groups are making the rounds on Capitol Hill this week to push their priorities as the House and Senate move their respective packages. Doctors for America met with member offices Monday to urge tweaks in the House bill's accelerated approval reform language. The organization wants the bill to include automatic expiration for drugs failing to show benefit in post-approval studies and a confirmatory post-approval study requirement, said Reshma Ramachandran, who leads the group's FDA task force. The Partnership to Fight Infectious Disease, the Cystic Fibrosis Foundation and other groups will host a reception on the Hill on Wednesday to highlight antimicrobial resistance, including legislation like the PASTEUR Act, H.R. 3932, S. 2076. That bill was included in Reps. Diana DeGette(D-Colo.) and Fred Upton's (R-Mich.) CURES 2.0 legislation. And the Alzheimer's Association is holding its fly-in this week. SENATE USER FEE PACKAGE ANTICIPATED TODAY — Senate HELP Chair Patty Murray (D-Wash.) and ranking member Richard Burr (R-N.C.) plan to release a discussion draft to reauthorize FDA's medical product user fee programs today, a GOP Senate HELP Committee aide told POLITICO. "This draft will include regulatory reforms on diagnostic testing, cosmetics and dietary supplements," the aide said.   DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED:  Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today.     Coronavirus CDC'S VACCINE ADVISORY COMMITTEE TO MEET THURSDAY — The Centers for Disease Control and Prevention's vaccine advisory committee will meet virtually Thursday at 11 a.m. EDT. A senior administration official said it will cover Pfizer-BioNTech's Covid booster shot for kids ages 5–11, which FDA is expected to authorize as soon as Tuesday. FDA DECLINES TO GRANT COVID EUA FOR FLUVOXAMINE — FDA has declined to grant an emergency use authorization request for fluvoxamine maleate to be used to treat Covid-19, according to a document posted last week. The selective serotonin reuptake inhibitor, commonly prescribed for children and adults with obsessive-compulsive disorder, was examined in three clinical trials, but FDA determined the data is inconclusive to support endorsing the drug's use to prevent Covid outpatients from progressing to severe disease. FDA AUTHORIZES LABCORP COVID, FLU, RSV TEST — FDA Monday authorized the first nonprescription direct-to-consumer mail-in laboratory-based test — made by Labcorp — that can detect Covid-19, flu A and B, and respiratory syncytial virus. EC AGREES TO SLOWER BIONTECH, PFIZER VACCINE SCHEDULE — The European Commission and BioNTech and Pfizer have agreed to alter the companies' Covid-19 vaccine delivery schedule, the drugmakers disclosed Monday. "Doses scheduled for delivery in June through August 2022 will now be delivered in September through fourth quarter 2022," a Securities and Exchange Commission filing states. WHITE HOUSE PLANS COVID BRIEFING — President Joe Biden's chief medical adviser Anthony Fauci, Covid-19 response coordinator Ashish Jha and CDC Director Rochelle Walensky are scheduled to brief the press Wednesday at 10:30 a.m. EDT. Eye on FDA WOODCOCK WEIGHS IN ON ARPH-A — If the proposed Advanced Research Projects Agency for Health is created, new treatment candidates would need to engage with FDA early on to help determine appropriate clinical testing design, FDA principal deputy commissioner Janet Woodcock said Monday at the Reagan Udall Foundation for the FDA's annual public board of directors meeting. "If ARPA-H is to be successful, not just in discovering and early development, but actually getting innovations, real innovation through the health care system, FDA is going to have to be right on top of that," Woodcock said. HOSPITALS GRAPPLE WITH IV CONTRAST SHORTAGE — A shortage of intravenous contrast media products stemming from the temporary shutdown of a major GE Healthcare manufacturing plant in Shanghai due to China's Covid-19 lockdown measures is causing health care professionals around the country to decide which patients most urgently require treatment, David reports. GE Healthcare's Omnipaque and Visipaque contrast media products were added to FDA's drug shortage list on May 9. The company has reopened the factory and is working to return more production capacity. "As reflected in the Drug Shortage List, for both Omnipaque and Visipaque, the manufacturer expects supply increasing through May and June with a return to stocking levels in July 2022,"" FDA spokesperson Audra Harrison said in an email.   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.     Tobacco FDA regulators will update attendees at today's E-Cigarette Summit on the status of its e-cigarette decisions. | Getty Images FDA REGULATORS TO PROVIDE AN UPDATE ON E-CIGARETTE DECISIONS — Today, members of the e-cigarette industry, academia and regulators will gather in downtown D.C. for the one-day E-Cigarette Summit. Of note, Matthew Holman, the director of FDA's Office of Science in the Center for Tobacco Products, is giving an update on the status of the agency's review of premarket tobacco applications for e-cigarettes. He will also participate in a panel discussion on e-cigarette regulation's impact on tobacco harm reduction. For context: The agency made more regulatory decisions on vapes from R.J. Reynolds last week but has remained mum on any applications from Juul, one of the only major companies yet to have a product cleared or denied. Other topics on the docket: Speakers are slated to discuss the risks of e-cigarettes compared with traditional cigarettes, how e-cigarettes might help smokers quit and trends in youth uptake. Katherine will be watching closely; send observations and questions to kfoley@politico.com. Coming Up in Pharma Wednesday — Lauren is moderating a panel titled "Our Children and Community: A Conversation on Vaccines and Impacts of COVID-19" at the Congressional Hispanic Caucus Institute's Issue Summit on Health. Thursday — FDA Commissioner Robert Califf will testify at 10 a.m. EDT before the House Appropriations Committee on the agency's fiscal 2023 budget request and its response to the infant formula crisis. Industry Intel GILEAD TO RESUME HIV TREATMENT TESTING — FDA has lifted the clinical hold it issued for Gilead's investigation of lenacapavir, an injection aimed at treating and acting as a pre-exposure prophylaxis for HIV, the company announced Monday. It will resume clinical trials imminently. Pharma Moves Former FDA chief digital health officer Bakul Patel announced on LinkedIn Monday he is joining Google Health as senior director of global digital health strategy & regulatory. The Food and Drug Law Institute announced Monday Christine Simmon will be its new president and CEO in early July. The Association for Accessible Medicines announced Monday Craig Burton will become the executive director of the Biosimilars Council at the end of May. Pharma Worldwide Covid cases are low in Ghana, just as the country finally has enough vaccinations for its population. The challenge now, POLITICO's Erin Banco reports from the ground, will be convincing people to get the shot. Quick Hits People are proving to be easily reinfected with Omicron's subvariants, with some potentially getting three or four infections this year, The New York Times' Apoorva Mandavilli reports. Some experts are calling for Covid-19 vaccines to be updated more quickly — even more so than those for the flu — to keep up with evolving strains. FDA and Abbott Nutrition agreed on plans for the company to reopen an infant formula processing plant currently closed because of an investigation of a bacterial outbreak at the facility, POLITICO's Meredith Lee reports. Document Drawer FDA issued final guidance for drug manufacturers investigating out-of-specification test results for their products. The Office of Information and Regulatory Affairs is reviewing draft guidance from FDA's Center for Biologics Evaluation and Research on blood- and plasma-donor criteria. The Office of Information and Regulatory Affairs is reviewing a proposed rule that would set manufacturing requirements for tobacco products.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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