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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 Katherine Ellen Foley, Lauren Gardner and David Lim | Presented by CVS Health | With help from Emily Martin, Rachel Roubein and Gavin Bade | | | — FDA signed off on an Alzheimer’s treatment Monday, bucking its outside advisers. — The House Oversight Committee today will revisit efforts to rebuke the Sackler family. — The Biden administration is launching an effort to ensure domestic manufacturing capacity for critical medicines. It’s Tuesday, welcome back to Prescription Pulse. Only fully vaccinated tramps (like, well, us) are allowed into Bruce Springsteen’s Broadway show later this month. 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 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. | | | | | | FDA APPROVES ALZHEIMER’S THERAPY DESPITE MIXED EVIDENCE — On Monday, FDA cleared the first new treatment for Alzheimer’s disease in nearly 20 years. The decision, which was at odds with the wishes of the agency’s external advisory group, regulatory watchdogs, and many neuroscientists, raises new questions about whether the agency is lowering its burden of proof for drugmakers. FDA approved aducanumab, made by Biogen in partnership with Eisai, on an “accelerated approval” pathway, which means the companies are required to conduct an additional clinical trial. “This pathway allows FDA to provide patients suffering with a serious disease earlier access to a potentially valuable drug when there is some uncertainty of the clinical benefit of the drug," Patrizia Cavazzoni, the FDA's top drug regulator, told reporters on Monday. FDA may revoke its approval if the results aren’t convincing, or if Biogen begin the trial in a timely manner. Groups that pushed for aducanumab’s approval see the decision as an open door for future treatments. “History has shown us that approvals of the first drug in a new category invigorates the field, increases investments in new treatments and encourages greater innovation,” Maria Carrillo, the chief science officer of the Alzheimer’s Association, said in a statement. But many health experts fear aducanumab’s approval sets the wrong tone for FDA going forward. “This signals a really bad step that's going to diminish the integrity of FDA's regulatory decisions and public confidence," said Joseph Ross, a physician at Yale University and co-director of the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation. “In this case, it's very clear patients will be exposed to risk from the treatment, and there's absolutely no suggestive data to indicate the treatment is beneficial,” Peter Bach, the director of the Center for Policy and Health Outcomes at Memorial Sloan-Kettering Hospital, told POLITICO. “At that point it's just a political move. That's the only thing that can hold sway if it's not science.” THE NEXT HUGE ALZHEIMER’S TREATMENT DECISION — CMS now must weigh how to cover aducanumab, granting the agency immense power over how accessible the drug will be for patients. The focus on the federal Medicare and Medicaid agency will intensify in the coming days. CMS can decide to launch a Medicare National Coverage Determination — or an insurer can request one — beginning a months-long process to create a national standard for how the drug is covered. That could lead the agency to put in place de facto clinical guidelines if it winds up limiting coverage — a move that’s sure to be controversial. "Today’s milestone provides hope to families, caregivers and the older Americans living with Alzheimer’s who rely on Medicare for health coverage," a CMS spokesperson said. "CMS is reviewing the FDA’s decision regarding aducanumab and will have more information soon." The tension points: “CMS generally covers FDA approved treatments, but CMS is also not supposed to issue payment for services that are not reasonable and necessary,” said Sean Dickson, health policy director at West Health Policy Center. And in the states, Medicaid programs — which already face budgetary pressures — will have to make a determination of their own. Drugmaker Biogen estimates that aducanumab will cost $56,000 per year for an average-sized patient. FDA APPROVES SMALLPOX TREATMENT — On Friday, FDA approved Tembexa, manufactured by Chimerix, to treat smallpox. Although scientists deemed the virus to be eradicated in 1980, FDA gave the drug priority review, fast track and orphan drug designations, on the basis that the virus could still be used as a bioweapon. FDA APPROVES WEIGHT-LOSS DRUG — Wegovy, an injection, received FDA approval on Friday, making it the first drug since 2014 to be approved for curbing appetite in patients with obesity. | | | | 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. | | | | | | | | BIDEN INVESTS IN ADVANCED DRUG MANUFACTURING — The Biden administration today unveiled new actions aimed at bolstering the supply chain for domestic drug manufacturing. To prevent shortages of key medicines, HHS will establish an onshoring consortium with major drugmakers under authority of the Defense Production Act, a Cold War-era law that allows the government to mandate production of key products. The group’s first task will be to identify 50 to 100 drugs for an “enhanced onshoring effort,” according to a fact sheet from the administration. A senior administration official told reporters HHS will also invest $60 million in American Rescue Plan funds into domestic active pharmaceutical ingredient manufacturing capacity. The effort is intended “to convene public-private stakeholders together without fear to share information, best practices and to cooperate without fear of running afoul of antitrust provisions," the senior official said. MORE PROMISING DATA ON mRNA SHOTS — The CDC has collected more real-world evidence on the efficacy of Pfizer’s and Moderna’s Covid-19 vaccines, finding they reduce infection risk by 91 percent in fully vaccinated people. The study results announced Monday are based on four additional weeks of data collected from frontline health care and other workers most at risk of coming into contact with the virus. The data also further support the notion that those vaccinated individuals are less likely to spread the virus to others and more likely to have milder symptoms, if any, for a shorter period of time than unvaccinated people. FDA AUTHORIZES ORASURE COVID TESTS — OraSure Technologies announced Monday it received emergency use authorizations from FDA for three Covid-19 antigen tests for over-the-counter non-prescription, point-of-care and prescription home use. The company says it can manufacture 55 million tests annually. STATES SCALE BACK COVID DATA REPORTING — More than two dozen states and territories are scaling back how often they are reporting data about the Covid-19 pandemic — decisions that will impede the nation’s ability to track emerging variants and case spikes, according to Johns Hopkins Coronavirus Resource Center data lead Beth Blauer. | | | SCOTUS PASSES ON VAPING CASE — The Supreme Court declined Monday to take up a petition by a Mississippi vape shop and the U.S. Vaping Association challenging the FDA’s ability to regulate e-cigarettes. The plaintiffs argued that the high court should invoke the nondelegation doctrine, a legal principle that holds that Congress cannot delegate its legislative authority to another branch of government. | | | |   | | | | | | SACKLERS IN THE HOT SEAT, AGAIN — The attorneys general of Idaho and Massachusetts will testify before the House Oversight Committee this afternoon in favor of legislation, H.R. 2096, they say would prevent individuals like members of the Sackler family from escaping liability from government-filed lawsuits. Committee Chair Carolyn Maloney (D-N.Y.) has argued that legal ambiguities have spurred some bankruptcy courts to release claims lodged by states, municipalities and the federal government. In the case of the Sacklers, their pharmaceutical company Purdue Pharma filed for bankruptcy in September 2019; while family members were named in several lawsuits, they asked the court to halt proceedings against them despite not filing for bankruptcy themselves. Idaho Attorney General Lawrence Wasden, a Republican, has endorsed Maloney’s legislation, but no GOP members of Congress have signed onto the bill. | | | | 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. | | | | | | | | NIH BACKS VACCINE HESITANCY STUDIES — The NIH’s National Institute on Minority Health and Health Disparities is funding a handful of efforts to combat or to study vaccine hesitancy among groups that experience health disparities. The grantees’ goals are to assess how to ensure equitable vaccine uptake in different settings and to consider barriers to access to and acceptance of the shots. | | | The Pharmacy Compounding Advisory Committee will meet Wednesday at 9:45 a.m. Eastern to consider four bulk drug substances nominated to be added to the 503A Bulks List. The Vaccines and Related Biological Products Advisory Committee will meet Thursday at 8:30 a.m. Eastern to consider the data necessary to approve Covid-19 vaccines for children. | | | AstraZeneca’s board has appointed Aradhana Sarin as an executive director and chief financial officer, conditional upon the company’s acquisition of Alexion Pharmaceuticals. Brett Baker, a top health adviser to Senate Finance and House Ways and Means Republicans, is leaving the Hill after more than a decade to join The Nickles Group’s health care practice (h/t POLITICO Influence). Zimmer Biomet announced Monday Wilfred van Zuilen will be its new president of Europe, Middle East and Africa. The medtech company also named Nitin Goyal as its chief science, technology and innovation officer. | | | MODERNA MOVES ABROAD — Moderna filed Monday for authorization from Health Canada for its Covid vaccine to be administered to teens. It also filed for condition marketing approval from the European Medicines Agency for the same cohort. The company said it plans to file for an EUA to expand its use in the U.S. to teens. EU DEBATES VACCINATING KIDS OR DONATING DOSES — Europe is grappling with an ethically fraught decision on whether to expand vaccination to children or donate jabs to those who need them most in the rest of the world, POLITICO’s Ashleigh Furlong reports. So far, no EU country has pledged to delay jabs for kids and send these vaccine elsewhere. Several are preparing to begin vaccinating adolescents this month after the European Medicines Agency approved Pfizer’s shot for children aged 12-16. | | 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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That’s health care, from the heart. Learn more. | | | | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for the FDA. FDA lays out expectations for drug supply chain security — The FDA last week released four guidance documents on how pharmaceutical manufacturers, drug wholesalers, logistics firms and pharmacies can better secure the pharmaceutical supply chain under the Drug Quality and Security Act of 2012. That law established a “track and trace” requirement in a bid to stop counterfeit drugs from reaching patients. The guidance contains recommendations on how to set up interoperable systems for sharing drug data (including distributed systems like blockchain), how to handle mistakes in the data, permission to use data “aggregation” methods to streamline drug distribution, and key definitions. Of note: FDA’s definition of a “diverted” drug may inadvertently flag any drugs imported into the U.S. from Canada under its drug importation final rule. Biosimilar user fee negotiations focus on interchangeability and regulatory science — A new batch of meeting minutes published last week by the FDA provide another glimpse at the ongoing negotiations to reauthorize the Biosimilar User Fee Amendments (BsUFA). The program, last authorized in 2017, is set to expire in September 2022. Negotiations in recent weeks have focused on the development of pilot regulatory science programs to support more efficient approvals, a proposal for a new type of regulatory development meeting during the review process, and the creation of additional guidance documents on interchangeability. An interchangeable biosimilar is one that is virtually identical to another biologic, allowing it to be effectively substituted for the latter in clinical practice. | | | Rollout of Johnson & Johnson’s single-dose vaccine has slowed to a crawl, with half of the 21 million doses produced for the U.S. sitting unused, Reuters reports. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
