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Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Lauren Gardner, David Lim and Katherine Ellen Foley | Presented by CVS Health | With Alice Miranda Ollstein
| | | — House lawmakers are zeroing in on possible riders to the FDA user fee reauthorization bill expected to move this year. — Brown University’s Ashish Jha will take over as Biden’s Covid-19 response coordinator in April. — The 30-day countdown until FDA can regulate synthetic nicotine products has begun. It’s Friday. Welcome back to Prescription Pulse. Our question for the day after Saint Patrick's Day: Is green beer blessed by FDA? Send tips, feedback and your favorite naturally-colored beverages 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 CVS Health: Throughout the pandemic, in communities across the country, CVS Health has been there. We’ve opened more than 4,800 COVID-19 test sites, administered 41 million tests and given 59 million vaccines. We’ve expanded access to prenatal and postpartum care via telemedicine, increased remote access to mental health services and invested in affordable housing to help build healthier communities. We’ve been on the frontlines, making health care easier to access and afford. Learn more. | | | | | | HOUSE PANEL REVS UP FOCUS ON POSSIBLE UFA RIDERS — The House Energy and Commerce’s health panel reviewed nearly two dozen bills Thursday that might be candidates for inclusion as riders in an FDA user fee reauthorization package later this year. Here’s a breakdown of the major focus areas: Whither ARPA-H: Rep. Cathy McMorris Rodgers (R-Wash.), the committee’s top Republican, registered concerns with differences between the House and the Senate on where the new agency would reside within Washington’s regulatory alphabet soup. Health Subcommittee Chair Anna Eshoo (D-Calif.) wrote a bill, H.R. 5585, to make it an entity within HHS, while the Senate’s pandemic preparedness legislation, S. 3799, would house it within NIH. "My concerns remain about accountability and the lack of a clear mission for” the proposed advanced biomedical research agency, McMorris Rodgers said. Eshoo said her bill is designed so the new agency’s work isn’t “duplicative” with that of existing federal scientific agencies and similarly modeled agencies function best under the broader umbrella of Defense and Energy departments. Clinical trial diversity: The general consensus was that more must be done to include diverse populations in clinical trials for medical products and therapies to ensure treatments work across various demographics, including pregnant and lactating people. Still, Lucy Vereshchagina, PhRMA’s vice president for science and regulatory advocacy, cautioned that mandates could end up “reinforcing rather than overcoming known barriers to participation,” including making studies “unfeasibly large and long.” Cures 2.0: Rep. Fred Upton (R-Mich.) said he’s gotten bipartisan feedback on his and Rep. Diana DeGette’s (D-Colo.) legislation to build on a 2016 law intended to accelerate cure discoveries for deadly diseases. They’ll review comments next week, once he’s back on the Hill after isolating with a case of Covid. Accelerated approval: Energy and Commerce Chair Frank Pallone (D-N.J.) used the hearing to tout his new legislation, H.R. 6963 , to expedite FDA’s data collection on drugs granted accelerated approval to ensure the treatments benefit patients. But McMorris Rodgers has introduced her own bill to overhaul the pathway, suggesting any effort to legislate on accelerated approval will require a lot more work to ensure it doesn’t tank the must-pass user fee package. DRUG PRICING HEARING HIGHLIGHTS DIVISIONS — Senate Democrats touted Wednesday’s hearing on high drug prices as a cornerstone of their efforts to revive a narrower version of the Build Back Better package that flamed out at the end of last year. While they’re now focusing squarely on lowering health and energy costs, Alice reports the hearing shined a light on the major hurdles that stand in the way of that goal. The window for action is closing: Democrats’ ability to pass a bill under reconciliation with 50 Senate votes ends in September. The closer they get to the 2022 midterms, when they could lose control of one or both chambers, the harder it will be to pass major legislation. Democrats are skeptical of partial solutions: While Senate Majority Leader Chuck Schumer reiterated Wednesday he plans to bring up Sen. Raphael Warnock’s (D-Ga.) bill to limit out-of-pocket costs for insulin to $35 a month, some Democrats are questioning that strategy. Most Republicans are opposed to the narrow insulin-only measure as well as broader negotiation: Throughout the hearing, GOP senators and conservative witnesses argued that Warnock’s bill would destroy competition and innovation in the insulin market.
| | | | 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. | | | | | | | | MODERNA ASKS FDA TO AUTHORIZE SECOND BOOSTER DOSE — On Thursday, Moderna requested that FDA grant emergency use authorization to a fourth dose of its Covid-19 vaccine for adults who already received a booster dose of any approved or authorized shot. FDA is set to convene its advisory committee of vaccine experts next month to deliberate how to approach Covid booster shots moving forward, including whether and when they’ll be needed and for which populations. JHA TO REPLACE ZIENTS AS COVID CZAR — The Biden administration announced Thursday that Ashish Jha, the dean of Brown University's School of Public Health, will replace Jeffrey Zients as the nation’s Covid-19 response coordinator in early April, POLITICO’s Samuel Benson reports. EUROPE COVID SURGE WORRIES WHITE HOUSE — The spike in Covid-19 cases across Europe is causing President Joe Biden’s health aides to worry that a spring wave of infection could crash on U.S. shores not long after the administration said most Americans could doff their masks. Covid waves in the U.S. have historically mimicked those in Europe but come several weeks later, POLITICO’s Erin Banco, Adam Cancryn and Krista Mahr report. U.N.-BACKED GROUP NABS PAXLOVID GENERIC DEAL — The U.N.-supported Medicines Patent Pool announced an agreement with 35 global companies Thursday to manufacture a generic version of Paxlovid, Pfizer’s Covid-19 therapeutic, POLITICO’s Daniel Payne writes. A dozen countries will host the manufacturing, which could begin early next year and would allow 95 low- and middle-income countries to access the drug.
| | | |   | | | | | | RESEARCHERS DISCUSS NEXT STEPS FOR FDA’S SYNTHETIC NICOTINE REGULATION — In less than 30 days, FDA’s tobacco regulators will be able to regulate products with synthetic nicotine like traditional tobacco products. At this week’s meeting of the Society for Research on Nicotine and Tobacco, the Center for Tobacco Products’ outgoing director Mitch Zeller stayed mum on details for how the agency planned to get synthetic vape regulation off the ground. But researchers attending the conference told Katherine what they expect to see: Delayed enforcement: “It’s very possible FDA can exercise its enforcement discretion,” said Micah Berman, a professor of public health and law at Ohio State University. FDA may not remove some vapes from the market as it reviews their marketing applications. Industry workarounds: The need for the law granting FDA authority over synthetic products came from a loophole — and it likely won’t be the last, said David Ashley, a research professor in the School of Public Health at Georgia State University and former CTP Office of Science director. “Whenever FDA passes a regulation or a law is written, the law has to be specific enough to be enforceable,” he said. “But the more specific the law is, it creates loopholes and unintended consequences.” U.S. ADULT SMOKING HITS RECORD LOW, ACCORDING TO CDC STUDY — Cigarettes are less popular among American adults now than they have been in more than 50 years, Katherine reports. A CDC analysis of the National Health Interview Suvey found that in 2020 roughly 31 million adults, or 12.5 percent of the population 18 and older, regularly smoked, compared with 14 percent in 2019. The figures were the lowest recorded since 1965 when the same survey found that 42 percent of adults smoked. FTC ISSUES FIRST REPORT ON VAPING ADVERTISING AND SALES — Between 2015 and 2018, e-cigarette sales boomed from $304.2 million annually to $2.06 billion , according to a new report from the Federal Trade Commission published Thursday. The report also found that e-cigarette advertising increased from $197.8 million in 2015 to $643.6 million in 2018. Combined with strategies to give out free or heavily discounted vape products to new customers, the Commission found that these marketing tactics partly contributed to youth vaping rates surging until 2019. Since then, youth vaping has decreased.
| | | FDA TO CONVENE WORKSHOP ON NALOXONE ACCESS — FDA and the Reagan-Udall Foundation will hold a virtual meeting on March 29 to discuss strategies to increase access to naloxone, the opioid overdose reversal drug. FDA: ABILITY TO MANDATE DEVICE SHORTAGE REPORTING CRITICAL — Only one-third of manufacturers responded to a voluntary request from FDA at the start of the pandemic, which asked for information about potential medical device shortages, according to a new fact sheet published by the agency Thursday. The agency gained limited authority to require such disclosure under the CARES Act but is now making the case that broader requirements on device firms would help mitigate supply-chain problems before they affect patients. “To better protect public health, the statutory authority should be revised to require notifications from manufacturers to CDRH any time there is the potential for a device shortage (similar to the FDA’s broader authority for drugs) — and not just during or in anticipation of a [Public Health Emergency],” FDA said.
| | | | DON’T MISS POLITICO’S INAUGURAL HEALTH CARE SUMMIT ON 3/31: Join POLITICO for a discussion with health care providers, policymakers, federal regulators, patient representatives, and industry leaders to better understand the latest policy and industry solutions in place as we enter year three of the pandemic. Panelists will discuss the latest proposals to overcome long-standing health care challenges in the U.S., such as expanding access to care, affordability, and prescription drug prices. REGISTER HERE. | | | | | | | | Molly Meegan is now chief legal officer and general counsel at the American College of Obstetricians and Gynecologists.
| | | CANADA APPROVES MODERNA SHOT FOR KIDS 6 TO 11 — Health Canada approved Moderna’s Covid-19 vaccine for children ages 6 to 11 Thursday. A primary series for the age group is two 50-microgram doses. TRIPS WAIVER COMPROMISE — The EU, South Africa, India and the U.S. have reached a compromise in long-running negotiations around a waiver on intellectual property rights, known as TRIPS, for coronavirus products, according to a document seen by POLITICO. The text could signal the start of a resolution to the debate that has been deadlocked at the World Trade Organization since October 2019, but it still needs agreement from EU member countries and other WTO members, POLITICO Europe’s Ashleigh Furlong reports.
| | | The White House’s regulatory office is reviewing FDA draft guidance on medical device cybersecurity and a proposed rule that could boost the availability of over-the-counter drugs on the market. The EPA released a white paper Thursday detailing its challenge aimed at boosting indoor air quality in buildings to cut down the spread of Covid-19 and other infectious diseases. FDA on Tuesday published draft guidance on development of Chimeric Antigen Receptor T Cell Products and human gene therapy products that incorporate human genome editing.
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