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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 and David Lim | Presented by CVS Health | With Katherine Ellen Foley, Alice Miranda Ollstein, Sarah Owermohle and Emily Martin. | | | — The decision to green-light a controversial Alzheimer’s drug is providing fresh fodder to critics of FDA Acting Commissioner Janet Woodcock. — FDA’s vaccine advisory panel weighed how to measure Covid shots’ safety in kids. — The top Democratic tax-writer in the Senate plans to rewrite his previously bipartisan drug pricing bill to include Medicare price negotiation, a move that would endanger GOP support. | | A message from CVS Health: Throughout the pandemic, CVS Health has been there. We’ve opened 4,800 COVID-19 test sites, administered 23 million tests and given more than 17 million vaccine doses. We’re offering same-day and walk-in appointments for vaccines at more than 9,600 CVS Pharmacy locations across all 50 states, Puerto Rico and Washington, D.C. We’re vaccinating adolescents 12+ at more than 5,600 Pharmacy locations nationwide. We’ve been on the frontlines, making health care easier to access and afford. Learn more. | | | It’s Friday, welcome back to Prescription Pulse. POLITICO’s cannabis reporter wants Sen. Bernie Sanders to know it is not a job requirement to be stoned. 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). | | | WOODCOCK WATCH HEATS UP AFTER ALZHEIMER’S DRUG CALL — FDA’s controversial decision to green-light a questionably effective Alzheimer’s drug earlier this week is cementing opposition to acting commissioner Woodcock, who remains in the running to become the agency’s permanent leader. While sources familiar with his thinking say President Joe Biden was happy with the approval — and appears to still favor Woodcock for FDA’s top job — critics in and out of government say the OK for aducanumab represented a “failure of leadership” on her part . She was noticeably absent from the agency’s statement approving the drug Monday and from a post-announcement press conference. Woodcock isn’t without her defenders, who say the Alzheimer’s drug decision shows she’s willing to back up the decision-making of agency scientists even when she’s bound to take the heat. Republican senators have said they’d support Woodcock’s nomination, meaning she’d likely have the votes to get confirmed. But the White House is grappling with a handful of Democrats — including frequent bugaboo Joe Manchin — who have criticized Woodcock’s past work overseeing the approval of opioids that sparked an epidemic with no end in sight. And FDA’s aducanumab approval adds another layer to the drama. To wit: A third member of the outside advisory panel that unanimously recommended against the drug resigned his post Thursday, STAT reported. KID COVID-19 VACCINES: 3 TAKEAWAYS FROM THE FDA’S BIG MEETING — Committee members met virtually Thursday to discuss the kinds of safety and efficacy data they’d need to see before authorizing more Covid-19 vaccines for use in kids and adolescents. Only the Pfizer-BioNTech shot has been authorized for use in teenagers. Moderna filed for its vaccine to be authorized for teens this week. Safety and adverse effects a top concern: Of note, committee members discussed risks of both Covid-19 and the vaccine in children. Most children have less severe cases of Covid-19 than adults, which is an indication against the necessity of vaccines for them. Still, kids can be susceptible to a multi-organ inflammatory reaction that results from Covid-19, and pediatric hospitalizations have been on the rise. Committee members also expressed interest in having the largest clinical trial possible to observe even the rarest adverse events related to the vaccine, which even late-stage trials in adults may miss. | | | |   | | | | | | FINANCE DEMS BEGIN REVAMPING DRUG PRICING BILL — Senate Finance Chair Ron Wyden (D-Ore.) intends to update the 2019 drug pricing bill he co-wrote with Sen. Chuck Grassley (R-Iowa) to allow some form of Medicare price negotiation — an effort Grassley warns is a non-starter, Alice Miranda Ollstein reports. The duo’s original bill would cut subsidies from drug companies that raised prices more than the cost of inflation. “Not only are too many Americans forgoing or rationing their prescriptions, sky-high drug prices could bust our health care budgets,” Wyden said during a Thursday hearing on HHS’ budget for the coming year. “We are all hungry for genuine medical breakthroughs, but what does it mean, senators, if the vast majority of Americans cannot afford them?” HHS Secretary Xavier Becerra endorsed the general effort, praising lawmakers for putting forward “a number of good ideas,” including rebates and more oversight mechanisms. But as in other hearings this week, he declined to say what exact policies he supports. “Innovation is effective only if people can afford it,” he said. Grassley: Assume bill dead — Grassley insisted that Medicare price negotiation “can’t get 60 votes” in the Senate and suggested that House Democrats’ sweeping drug pricing bill, H.R. 3, has “no path forward,” noting that the measure was not included in Biden’s HHS budget proposal. Instead, Grassley urged Becerra to support his narrower, bipartisan bill, saying it could “easily get 65 to 70 votes in the Senate and maybe more than that” and that it could meaningfully regulate the drug industry. “Big Pharma doesn't like what Grassley and Wyden have been working on for two years,” he said. But several Finance panel Democrats made it clear they won’t settle for the original Grassley-Wyden as-is, which Sen. Elizabeth Warren (D-Mass.) called a “watered-down half-measure” as she demanded “drug price negotiation with real muscle.” WOODCOCK SKATES THROUGH SENATE BUDGET HEARING — Senators on the Appropriations panel for food and drugs peppered Woodcock with questions about speeding up drug approvals, investigating teen nicotine addiction and updating food policy, in a sign that pre-pandemic priorities have returned to the forefront of many lawmakers’ minds, POLITICO’s Sarah Owermohle reports. Blink and you’d miss Biogen’s Alzheimer drug. While Republican Sens. Jerry Moran and Mike Braun alluded to aducanumab — and hope for its benefit in Alzheimer’s patients — no one grilled Woodcock on the controversial approval. Braun instead asked how FDA could speed approvals for a range of neurodegenerative diseases, like ALS. “In neurodegeneration, we’re still in a more primitive area of science,” she told the senator. “The problem is more in the development area – we are still in empirical development...which means just try it and see if it works.” And no mention of a permanent chief. While senators commended Woodcock on her experience at the agency and navigating through a pandemic, they didn’t question when Biden would name a permanent commissioner nominee, or if it would be Woodcock. Senators instead raised that — and aducanumab — in a concurrent Finance committee hearing with Becerra. | | | | 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 22-23. | | | | | | | | FDA ISSUES WARNING LETTER TO INNOVA — Americans should not use a rapid Covid-19 antigen test made by Innova Medical Group, the FDA warned Thursday. The agency noted it has “significant concerns” about the performance of the unauthorized test in part because its labeling “includes performance claims that did not accurately reflect” clinical studies. “FDA further notes that the clinical study data you submitted in your EUA request for the SARS-CoV-2 Antigen Rapid Qualitative Test was identical to data previously provided by other manufacturers in their separate EUA requests,” the agency wrote in a warning letter issued to Innova. More than 77,000 of the devices have been recalled in the U.S., according to a Class I recall notice. FDA ADDS NEW DEVICE TO SHORTAGE LIST — The FDA announced Thursday it is adding sodium citrate tubes — used in blood collection — to its medical device shortage list. FDA APPROVES MEDTRONIC VANTA SPINAL CORD STIMULATION IMPLANT — Medtronic announced Thursday the FDA approved its Vanta next-generation spinal cord stimulation platform. AVITA GETS EXPANDED LABEL FOR BURN TREATMENT SYSTEM — Avita Medical announced Thursday the FDA expanded approval for the company’s Recell system to now include pediatric patients older than one month. The burn treatment is also now indicated for burns that are larger than 50 percent of the total body surface area. | | | Jon Blum is the new principal deputy commissioner at CMS, according to a LinkedIn update. Former HHS Secretary Alex Azar joined the Aspen Health Strategy Group as an ex-officio in capacity, becoming the seventh former secretary to join the Aspen Institute sub-group led by Obama-era HHS chief Kathleen Sebelius. The National Association of Chain Drug Stores has promoted Sara Roszak to senior vice president of health and wellness strategy and policy; she was also elected president of the NACDS Foundation. Rachael Fleurence is now a senior advisor in the Immediate Office of the Director at the NIH. Taylor Mason, vice president of public affairs at KPM Group DC, has been named executive director of the newly formed Rare Disease Coalition. AHIP announced Thursday that CVS Health CEO Karen Lynch was elected to its board of directors. | | | | SUBSCRIBE TO "THE RECAST" TODAY: Power is shifting in Washington and in communities across the country. More people are demanding a seat at the table, insisting that politics is personal and not all policy is equitable. The Recast is a twice-weekly newsletter that explores the changing power dynamics in Washington and breaks down how race and identity are recasting politics and policy in America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear critical new voices that challenge business as usual. Don't miss out, SUBSCRIBE . Thank you to our sponsor, Intel. | | | | | | | | EU BACKS PATENT WAIVER FOR COVID VACCINES — EU lawmakers have voted in favor of a resolution that supports temporarily waiving patents for vaccines, POLITICO EU’s Barbara Moens and Ashleigh Furlong report. Ministers passed the resolution Wednesday with 355 in favor, 263 against, and 71 abstentions. The EU until now has opposed the waiver and has proposed other solutions to increase access to affordable coronavirus vaccines. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for the FDA. White House report floats reforms to drug supply chain — A report issued this week by the White House calls for reforms to the U.S. supply chain for pharmaceuticals and active pharmaceutical ingredients to better guard against foreign influence and the potential effects of future public health emergencies and natural disasters. Among the ideas promoted by the report: A “virtual stockpile” involving excess capacity at manufacturers, onshoring of pharmaceutical production for essential medicines, the collection and use of metrics measuring the quality of manufacturing facilities, and investments into “continuous manufacturing” technologies. Several of the ideas, including quality metrics and continuous manufacturing, have long been supported by acting FDA chief Woodcock. FDA prevails in legal fight over regulation of stem cells — The FDA recently won a key legal victory in a long-running fight to more closely regulate stem cell clinics and other producers of cellular and tissue-based products. The case involved a Florida-based stem cell clinic that had been warned by the FDA for marketing its product for a range of medical indications without agency approval. While the company had argued that its cellular product should not be regulated as a drug (and should therefore not require premarket approval by the FDA), both the U.S. Southern District of Florida and the U.S. Court of Appeals for the 11th Circuit sided with the FDA. The regulator had argued that because the cells had been processed and were not used for the same original biological purpose, they were indeed drugs. The decisions come just as the FDA has begun to crack down the marketing of cellular products lacking approval, which may lead to a wave of enforcement actions. | | A message from CVS Health: At CVS Health, we’re more than 300,000 caring employees ensuring millions of Americans can access health care services.
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Every day, CVS Health works to bring quality, affordable health care into neighborhoods, homes and hands—so it’s never out of reach for anyone.
That’s health care, from the heart. Learn more. | | | | | | At least 2,467 state lawmakers took funds from the drug industry to finance their campaigns in the 2020 election cycle, according to a data dive by STAT News. The Atlantic’s Ed Yong explores how the individualism of the U.S. populace shaped the nation’s response to the Covid-19 pandemic and now the nation’s vaccination campaign. | | | The FDA on Wednesday released draft guidance outlining recommendations for drug companies collecting patient-reported outcome measures in cancer clinical trials. The FDA Office of Prescription Drug Promotion found only 21 percent of disclosures on direct-to-consumer websites included language directly from approved physician labeling for drugs that received accelerated approval. The office is proposing new research to further explore how consumers understand accelerated approval disclosures. FDA announced that the COVID-19 Health Equity Task Force will hold a virtual meeting on June 25 at 2 p.m. FDA announced a virtual public meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee on July 14 at 9 a.m. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
