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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Lauren Gardner, Katherine Ellen Foley and David Lim | PROGRAMMING NOTE: We’ll be off next week for the holidays but will return to your inboxes on Wednesday, Jan. 4.
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A new report says the Center for Tobacco Products suffers from a lack of direction and unclear review processes for pre-market tobacco product applications. | Justin Sullivan/Getty Images | INDEPENDENT PANEL FINDS LACK OF CLARITY HINDERS TOBACCO REGULATION — The long-awaited Reagan-Udall report by former FDA and CMS officials found that the FDA’s tobacco regulator needs better enforcement and a streamlined review process to proactively regulate new tobacco products, Katherine reports. The report, published Monday, found that the Center for Tobacco Products is more reactive than proactive and plagued by litigation from frustrated parties who want to see the office doing more to help adult smokers switch to less harmful products while keeping minors from using nicotine and tobacco products. The five-person expert panel had several recommendations for CTP, including: — Create an Office of Policy to clarify tobacco regulatory priorities internally and to the public — Engage in more communication and transparency with tobacco product manufacturers about the data that needs to be in new product applications — Call on the Tobacco Products Scientific Advisory Committee, which hasn’t met since 2020, to meet regularly — Pursue user fees for other tobacco products it regulates, including e-cigarettes, to fund sufficient staff for handling new product applications — Work more efficiently with other government agencies to enforce decisions it makes about tobacco and nicotine-related products FDA Commissioner Robert Califf asked the Reagan-Udall Foundation, a nonprofit whose mission is to support the agency, to conduct an independent review of the agency’s tobacco program in July. In a statement, he said the FDA would have an update by early February on potential changes it will make to its tobacco regulatory program. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Isn’t it ironic how the shortest day of the year comes amid what’s always Congress’ longest week? Send tips, feedback and caffeine 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). TODAY ON OUR PULSE CHECK PODCAST, Ben Leonard talks with Mark Cuban, famous for his "Shark Tank" reality TV show on ABC and one of America's most prominent investors, about the Cost Plus Drug company he founded with Dr. Alex Oshmyansky to take on the pharmaceutical market and lower drug prices — and about his plan to try to disrupt the prescription drug space.
| | | | | | CONGRESS RELEASES YEAR-END SPENDING BILL — Leading lawmakers unveiled a $1.7 trillion year-end spending bill early Tuesday as they raced to pass the sprawling package by week’s end, with federal cash expiring at midnight on Friday. The so-called omnibus includes includes a deal that saves the government billions by ending pandemic era-Medicaid policies and directs some of the saved dollars toward giving low-income moms an extended coverage period on Medicaid in states that don’t offer it. The omnibus includes language to extend hospital at-home waivers for two years, running through the end of 2024, POLITICO's Ben Leonard reports. Ben also notes that lawmakers decided to sustain a ban on using federal dollars to craft unique patient IDs meant to pair patients with their health records. Physicians, who faced a 4.5 percent cut in Medicare rates in January, get a bit of a reprieve in the package. The new language would cut rates by 2 percent in 2023, and then 3.25 percent in 2024. The Office of the National Coordinator for Health IT got a boost in funding. The omnibus gives ONC $66.2 million, up from the roughly $62 million it got in fiscal year 2022. The office had pushed for $103.6 million to help the health care sector undergo its digital transformation. The Senate is expected to act first on the spending package in the coming days, seeking a time agreement that would allow the bill to pass before Thursday night and sending it to the House. Any senator could hold up that deal in exchange for amendments or concessions.
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The Alzheimer's Association wants CMS to take another look at monoclonal antibodies to treat Alzheimer's disease and allow unrestricted coverage of the drugs. | Biogen via AP | EXCLUSIVE: ALZHEIMER’S GROUP ASKS CMS TO RECONSIDER ANTI-AMYLOID COVERAGE — On Monday, the Alzheimer’s Association formally requested that CMS reconsider its coverage of monoclonal antibodies that target amyloid buildup on the brain to treat Alzheimer’s. The agency isn’t required to respond to the letter and didn’t immediately answer a request for comment. What the association wants: “We respectfully request that CMS remove the [trial and registry] requirements … to provide unrestricted coverage for FDA-approved mAbs [monoclonal antibodies] directed against amyloid,” the request says. Recap: After Aduhelm received accelerated approval in 2021, CMS said it would cover anti-amyloid monoclonals in two scenarios. For drugs like Aduhelm, whose approval is conditional, patients need to be in a randomized trial run through the FDA or the National Institutes of Health. For antibodies that have received full approval, CMS will cover treatments provided patients are enrolled in a patient registry. Since then, new data from trials for two other Alzheimer’s drug candidates have emerged. The group argues those findings further support the hypothesis that amyloid proteins are tied to progressive dementia associated with Alzheimer’s. Health care providers offer support: The association also included a letter signed by more than 200 health care providers to voice their confidence in recently published lecanemab data as additional evidence, saying there should be “no barriers” to accessing the drug if it’s approved. The FDA is set to make a lecanemab decision by Jan. 6.
| | | | POLITICO AT CES 2023 : We are bringing a special edition of our Digital Future Daily newsletter to Las Vegas to cover CES 2023. The newsletter will take you inside the largest and most influential technology event on the planet, featuring every major and emerging industry in the technology ecosystem gathered in one place. The newsletter runs from Jan. 5-7 and will focus on the public policy related aspects of the event. Sign up today to receive exclusive coverage of CES 2023. | | | | | | | | FDA TO CONVENE VAX ADVISERS ON COVID-SHOT MAKEUP — The FDA’s vaccine advisory committee will meet on Jan. 26 to consider whether and how both the formulations for Covid-19 vaccines’ primary series should change and the recipes and dose schedules adjusted in the future, as the pandemic shifts and the virus continues to mutate. Based on the committee’s advice, the agency will weigh whether to recommend changes to existing approvals and emergency use authorizations, as well as “the most efficient and transparent process” for strain selection, Peter Marks, the FDA’s top vaccine regulator, said in a statement. “We are hopeful this upcoming discussion will provide us with the optimal path forward for Covid-19 vaccines, helping to ensure that the public remains best protected from evolving virus variants,” he said. CDC RELEASES MORE OMICRON DATA — On Friday, the CDC published two studies on the effectiveness of the updated Omicron shots, adding to the recent literature suggesting they offer the biggest payoff for older individuals and people several months after their last monovalent doses. One study found that, among adults 65 and older with normal immune systems who were hospitalized for Covid-like illness from September through November, a bivalent booster offered 73 percent more protection against hospitalization from the disease compared with monovalent messenger-RNA vaccination only — and 84 percent additional protection compared with the unvaccinated. A separate study that included adults 18 and older indicated the updated boosters offer moderate protection against emergency room and hospital visits for Covid, especially compared with unvaccinated individuals or those who received a vaccine dose at least 11 months earlier. HHS AWARDS GRANTS TO BOOST VAX RATES AMONG AT-RISK — The Biden administration is funneling $125 million to two nonprofits to help dole out Covid shots to hard-to-reach older Americans and people with disabilities, POLITICO’s Megan Messerly scoops.
| | | FED WATCHDOG: FDA REVIEWS FOR SOME CIGARETTES WERE FLAWED — The Office of Special Counsel found Friday that the FDA’s Center for Tobacco Products had relaxed some standards for a subset of cigarette marketing applications in 2019 and its internal scientific dispute office failed to adequately respond to employee concerns. A whistleblower made two complaints to OSC: Employees were instructed to perform a less-rigorous review of a subset of cigarette marketing applications to deal with a glut of e-cigarette marketing applications, which led to more tobacco products hitting the market, and the CTP’s scientific dispute resolution office failed to adequately address employee concerns with the review process. As a result of OSC’s findings, the CTP revised a February 2019 memo to include options for employees to more thoroughly review tobacco products under the substantial equivalence pathway.
| | | Michawn Rich is joining Nevada Gov.-elect Joe Lombardo’s office as director of policy. She previously was communications director for Senate HELP member Roger Marshall (R-Kan.).
| | | The U.S. District Court for the Western District of Oklahoma entered a consent decree Monday against an Oklahoma drug compounder, prohibiting it from directly or indirectly distributing adulterated drugs. U.S. Trade Representative Katherine Tai asked the U.S. International Trade Commission on Friday to investigate issues related to whether the WTO should waive intellectual property rights protections for Covid-19 therapeutics and diagnostics. Reps. Anna Eshoo (D-Calif.) and Brett Guthrie (R-Ky.) lead a letter to CMS Administrator Chiquita Brooks-LaSure requesting the agency issue a Transitional Coverage for Emerging Technologies proposed rule by the end of the year.
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