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Presented by Genentech: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Lauren Gardner and David Lim | Presented by Genentech | With Katherine Ellen Foley, Susannah Luthi and Emily Martin | | | — Acting FDA Commissioner Janet Woodcock is headed to Capitol Hill this week to testify on the FDA’s plan to address youth vaping. — The CDC’s vaccine advisory committee will meet this week on heart conditions seen in a small number of Covid vaccine recipients. The meeting was postponed from Friday to mark the Juneteenth holiday. — HHS has withdrawn controversial Trump-era guidance on a federal drug discount program. It’s TUESDAY, welcome back to Prescription Pulse. Your morning crew is waiting everlong for live music to return (and will be curious to see if more artists follow Springsteen and the Foos on this approach). Be sure to send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner ( lgardner@politico.com or @Gardner_LM) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). | | | | A message from Genentech: A person’s health shouldn’t be determined by their gender, race, sexual orientation, socioeconomic background or zip code. But data show these factors significantly influence access to care and health outcomes. Read more about how Genentech is challenging ourselves, and others, to pursue bold solutions rooted in population science, inclusive research, and philanthropy to realize the promise of personalized healthcare and optimized treatment outcomes for all. | | | | | | CDC COVID SHOT MEETING DELAYED FOR JUNETEENTH — Let’s try this again: The CDC’s vaccine advisory committee will now meet this week during its previously scheduled three-day confab to discuss the most recent data on cases of myocarditis post-Covid vaccination, particularly among young men who received either the Pfizer or Moderna shots. The meeting, originally scheduled for Friday, was postponed after President Joe Biden signed legislation making June 19 a federal holiday. The date commemorates the end of slavery in the U.S. in 1865. Per the updated agenda posted Monday , the Covid topics will be aired on Wednesday. The general risks and benefits of vaccination and the potential need for boosters are also on the docket. Ripe for discussion: The Covid vaccines’ closest followers are eager to hear more about the cases of myocarditis and pericarditis , inflammatory conditions of the heart, that have cropped up among a small but notable cohort of vaccine recipients. It’s taken on extra urgency as vaccine makers study the safety and efficacy of their products in younger children, and as the Delta variant spreads more widely across the U.S. HHS’ own vaccine committee broached the issue last week, with one participant who recently studied a handful of cases among adolescent males stating that the shots’ benefits “significantly exceeded the possible risks.” Still, Judy A. Guzman-Cottrill of Oregon Health & Science University said state health officials should ensure that parents are informed of the apparent myocarditis risk, while stressing how rare it is. Later in the week: The committee will vote Thursday on three shots targeting dengue, rabies and the flu. Friday’s session will focus on zoster and pneumococcal vaccines. BIDEN DROPS ASTRAZENECA VACCINE FROM LATEST DONATION — On Monday, the Biden administration provided more details on the 55 million vaccine doses the U.S. is planning to share with other countries, POLITICO’s Carmen Paun reports. Missing from those plans are the 60 million doses of vaccines from AstraZeneca, which the administration had originally planned to ship abroad even though the FDA has yet to authorize the two-dose immunization. The FDA is evaluating whether it’s safe to ship AstraZeneca’s vaccine abroad from its manufacturing plant in Baltimore. The vaccines that will go out from the U.S. come from Moderna, Pfizer and BioNTech, and Johnson & Johnson, all three of which the FDA authorized for emergency use. Most of these vaccines will go to COVAX recipient countries in Latin America, Asia, the Caribbean, and Africa. | | | | DON'T MISS THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO will feature a special edition of our Future Pulse newsletter at the 2021 Milken Institute Future of Health Summit. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators who are turning lessons learned from the past year into a healthier, more resilient and more equitable future. Covid-19 threatened our health and well-being, while simultaneously leading to extraordinary coordination to improve pandemic preparedness, disease prevention, diversity in clinical trials, mental health resources, food access and more. SUBSCRIBE TODAY to receive exclusive coverage from June 22-24. | | | | | | | | OVERSIGHT SUBCOMMITTEE TO HEAR TESTIMONIES ON YOUTH VAPING — On Wednesday, acting FDA Commissioner Janet Woodcock will address the House Subcommittee on Economic and Consumer Policy on youth vaping rates. MANCHIN DETAILS OPPOSITION TO WOODCOCK — Sen. Joe Manchin (D-W.Va.) is putting his key vote status to use in the “Waiting for Godot”-esque drama surrounding Janet Woodcock’s potential nomination to be FDA commissioner. The West Virginia Democrat outlined his most pointed opposition yet last week to the now-acting chief. In a letter to Biden last week, he cited the agency’s conditional approval of a questionably effective Alzheimer’s drug as another reason for the White House to take their candidate search elsewhere. Manchin’s stance on Woodcock wasn’t exactly a secret, but his disapproval had been quieter until now. Woodcock, previously the FDA’s longtime drug division director, has drawn the ire of senators from states ravaged by the opioid epidemic, and her critics have painted her as too cozy with industry. Manchin gave those reasons, plus the agency’s responsibility for licensing Covid vaccines and treatments, as to why he believes she “is not the right person to lead the FDA.” Remember that budget request? Woodcock reminded visitors to the FDA’s website on Monday that the agency’s fiscal 2022 budget request would help bolster its resources to combat the opioid crisis. The agency has asked lawmakers for about $36 million, money that would go toward developing pain treatments and preventing addiction, among other priorities. ALZHEIMER’S GROUP ‘ZOOMS’ IN — The advocacy group UsAgainstAlzheimer's is hosting its first virtual fly-in this week, with more than 75 meetings scheduled on the Hill for Alzheimer's advocates. They’re calling for higher federal funding for disease research, earlier detection and diagnosis, prevention, and paid leave for dementia caregivers (h/t POLITICO Influence). | | | HHS WITHDRAWS CONTROVERSIAL 340B GUIDANCE — The federal health agency on Friday withdrew guidance on a federal drug discount program “in the interest of avoiding confusion and unnecessary litigation.” The advisory opinion was issued in late December by Donald Trump’s general counsel for HHS and is currently the subject of drug company lawsuits, POLITICO’s Susannah Luthi reports. The move came after a federal judge last week refused to dismiss a lawsuit against the opinion and critiqued the guidance as an inappropriate stretch of the law around the increasingly contentious federal drug discount program known as 340B. HHS’ Acting General Counsel Daniel Barry said he disagreed with the court’s ruling and that it won’t entangle the federal health agency’s enforcement of the 340B program. “PhRMA is pleased with the Biden Administration’s decision to withdraw the legally flawed Advisory Opinion regarding 340B contract pharmacies issued in the waning days of the Trump Administration," PhRMA spokesperson Nicole Longo said. "We remain alarmed that for-profit corporations continue to flood and profit from the 340B program. More fights ahead: Meanwhile, drugmakers aren’t backing off their refusal to extend their generous discounts to contract pharmacies tapped to dispense drugs to providers in the 340B program, despite the agency’s threat of penalties. One manufacturer, Eli Lilly, has already argued in a letter to HHS that officials don’t have any “lawful or reasonable basis” to impose fines. | | | |   | | | | | | FDA DROPS PRESCRIPTION REQUIREMENT FOR BAYER ANTIHISTAMINE — Late last week, the agency approved the over-the-counter sale of Astepro, a nasal spray to treat seasonal allergies for adults and children 6 years and older. The drug still requires a prescription for use in children 6 months to 6 years. FDA APPROVES FIRST ORAL BLOOD THINNING DRUG FOR KIDS — The FDA on Monday announced it approved the first oral blood thinner for children ages 3 months to less than 12 years with venous thromboembolism. The Boehringer Ingelheim drug, Pradaxa, was first approved in 2010 to reduce stroke risk in adults. | | | FDA TRIES TO CLARIFY LINE BETWEEN DEVICE SERVICING AND REMANUFACTURING — The FDA on Friday issued draft guidance outlining what actions might constitute remanufacturing a medical device instead of repairing it to its original state. A 2018 report by the agency found that most complaints that inadequate device servicing led to adverse events “actually pertained to remanufacturing.” The imaging device industry praised the draft guidance as a “step in the right direction” but argued the agency should require all medical device servicers to register and document and report errors. “By detailing the importance of conducting risk analysis, ensuring proper documentation and education around remanufacturing and servicing, it is our hope that those entities performing unregulated and unaccountable third-party servicing can obtain a better line of sight into their work and regulatory responsibilities, especially when it veers into remanufacturing, which is often the case,” Medical Imaging & Technology Alliance Executive Director Patrick Hope said in a statement. The FDA also issued a discussion paper on Friday about mitigating medical device cybersecurity challenges. “Entities that service medical devices are well positioned to help identify cyber exploits and vulnerabilities, and to participate in the continued deployment and maintenance of devices,” the agency wrote. FDA ADDS EXAMPLES OF CLINICAL OUTCOME ASSESSMENT USE — The FDA on Monday added several case studies to its website outlining how medical device manufacturers can use clinical outcome assessments to support a submission. “COAs may be used to determine who is eligible for a clinical study and measure how well the device performs in treating or diagnosing the condition,” the FDA said. | | | | TUNE IN TO DISPATCH+ ON APPLE PODCASTS : POLITICO Dispatch, our daily podcast that cuts through the news clutter and keeps you up to speed on the most important developments of the moment, is expanding. In collaboration with the new Apple Podcasts Subscription platform, Dispatch+ launches this week! This new podcast gives premium Dispatch+ s exclusive bonus weekly reporting and analysis from POLITICO's newsroom. Don't miss out, subscribe and listen to Dispatch+ on Apple Podcasts. | | | | | | | | FORMER VACCINE FRONTRUNNER CUREVAC FALTERS — The German-made mRNA vaccine from CureVac was once so sought after that former President Donald Trump allegedly wanted to poach the company. European Commission President Ursula von der Leyen praised the vaccine as the “frontrunner” by offering the firm an €80 million loan, but that’s since changed, POLITICO EU’s Jillian Deutsch reports. Now, the CureVac vaccine is late to the game and coming up short after preliminary data showed it was only 47 percent effective in preventing Covid-19 cases in a shocking blow to the EU’s vaccination strategy. Commission spokespeople are declining to say whether the EU will toss out its contract with CureVac based on the preliminary data. | | | Payments to orthopedists and neurosurgeons who operate on the spine have risen sharply, despite government accusations that some may violate federal anti-kickback laws and put patients at risk, KHN reports. The spread of the coronavirus’ more contagious Delta variant could lead to a spike in infections this fall if only 75 percent of the eligible U.S. population is vaccinated, former FDA commissioner Scott Gottlieb said Sunday on CBS’ “Face the Nation.” When Rochelle Walensky took over the CDC in January, she inherited an agency whose public profile and staff morale had taken big hits under Trump, writes Erin Banco for POLITICO . Now that the agency faces its toughest task to date — reopening safely after a pandemic — it will fall on her shoulders to present clear, comprehensive guidance to the American public to recover its reputation as a beacon of public health. | | | HHS, the Department of Labor and the Treasury issued a request for information to gather public input on implementation considerations for data collection about prescription drug use and spending from private health plans, as required by the fiscal 2021 appropriations law, H.R. 133 (116). | | | | A message from Genentech: Having a serious illness is challenging enough without having to worry about being able to afford the necessary treatment. The reality is that out-of-pocket costs are a significant concern for many patients and – all too often – can prevent people from getting the care they need. We believe there are opportunities to implement smart solutions that lower costs for patients and the system, while sustaining the large research and development investments necessary to drive the medical breakthroughs that are urgently needed. Learn more about how Genentech is engaging with patients, advocacy groups, providers, payors, other businesses and legislators to explore market-based policy reforms. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
