CDC advisers ponder potential fall vaccines

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Jun 21, 2023 View in browser   By Katherine Ellen Foley and David Lim With Megan R. Wilson Driving the day An CDC advisory panel will review data for infectious disease vaccines this week to determine whether any should be recommended for the public. | Mario Tama/Getty Images IMMUNITY ON THE MIND — Independent experts for the CDC start meeting today to consider the latest data on vaccines for nearly a dozen illnesses and potentially recommend some for the public. The three-day advisory committee meeting is part of the panel’s regularly scheduled discussions. The CDC can choose whether to follow the experts’ guidance. Most insurance companies look to the CDC’s formal recommendations to decide which vaccines to cover for beneficiaries. The panel will discuss the latest data behind vaccines for 10 infectious diseases. Here’s what we’ll be watching: RSV: Today’s meeting kicks off with a discussion of the data behind two respiratory syncytial virus vaccines for adults ages 60 and older from Pfizer and GSK, which received FDA approval last month. Both companies will present new data on their shots’ efficacy over multiple seasons, as well as data on co-administration with annual flu shots. The companies have said they are prepared to deliver vaccinations in the fall; if the CDC recommends the vaccines, it will be the first time any population has immunization against the common respiratory virus. On Thursday, advisers will discuss Pfizer’s RSV candidate for infants, which is administered to pregnant individuals, as well as an antibody from Sanofi and AstraZeneca that can also boost infant protection against the disease. The committee will not vote to recommend the products because they haven’t been approved yet by the FDA. The regulatory agency is slated to decide on both products in the coming months. Mpox: On Friday, advisers will hear presentations on the epidemiology of mpox in the U.S. over 2022 and 2023 and the analysis of the safety and efficacy of Jynneos’ vaccine. The committee also won’t vote on this vaccine, but we expect to hear a discussion around long-term production against the virus formerly called monkeypox. Covid-19: The advisory committee meeting will conclude with a discussion of the latest data on Covid immunity. It’s too soon to consider data on the forthcoming Covid boosters; the FDA only green-lighted the XBB.1.5 strain as the fall target for vaccine manufacturers late last week. Instead, panelists will hear from CDC scientists on the updates to current vaccine effectiveness and the role of hybrid immunity in future protection. Listen for a robust debate around the merits of potentially boosting all populations. In the FDA’s advisory committee meeting discussing the target strain, some scientists suggested that healthy populations retain protection against severe disease even as protection against mild disease wanes. IT'S WEDNESDAY. WELCOME TO PRESCRIPTION PULSE. Enjoy the longest day of the year! Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Megan Messerly talks with Alice Miranda Ollstein, who explains how some groups are employing an unconventional legal tactic in their efforts to dismantle abortion bans by leveraging religious freedom. Listen to today’s Pulse Check podcast Eye on the FDA The FDA is working to ensure that cancer tests used to identify genetic mutations are accurate. | Jean-Philippe Ksiazek/AFP via Getty Images THE PUSH FOR QUALITY CANCER TESTS — Top FDA regulators unveiled a pilot program Tuesday that aims to ensure some tests used to help doctors choose cancer treatments are safe and effective. The agency is concerned about the accuracy and reliability of certain laboratory-developed tests — generally made and used by a single lab and not generally reviewed by the FDA — being used to help determine whether patients with specific genetic mutations may benefit from targeted drugs. The program, detailed in agency-issued guidance, will ask up to nine drugmakers to submit performance data on tests used to enroll patients in oncology-drug clinical trials. If the FDA approves a cancer drug within the program, it will post minimum test performance expectations to help labs develop tests that can identify biomarkers that can guide treatment decisions. “This pilot program demonstrates the FDA’s commitment to collaborating with the pharmaceutical industry and other key stakeholders to address concerns and questions around the use of unauthorized diagnostics,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said in a statement. The FDA said it continues to work on new regulations for a broader set of LDTs. The agency’s regulatory agenda indicates it plans to issue a proposed rule in August “to make explicit” that LDTs are defined as medical devices under federal law.   SUBSCRIBE TO POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don’t miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY.     Industry Intel FIRST IN RxP: CAMPAIGN AGAINST PHARMA AND PATENTS — The Campaign for Sustainable Rx Pricing is launching a seven-figure advocacy campaign that includes advertising, grassroots and grasstops in an effort to push patent reform, Megan reports. The group, whose members include large health insurer and hospital groups, is backing a slate of legislation moving on Capitol Hill that would thwart how large drugmakers use the patent system to maintain exclusivity over their products. The campaign is meant to “encourage policymakers to focus on holding brand-name drug companies accountable for their egregious pricing practices and abuse of the patent system that blocks competition from more affordable alternatives,” Lauren Aronson, a lobbyist and CSRxP's executive director, told POLITICO. For context: Insurers and pharmacy benefit managers have been in a policy tit-for-tat with the pharmaceutical industry, which is lobbying lawmakers to crack down on PBMs. PBMs negotiate discounts on medicines with drugmakers and decide which drugs insurance plans will cover. NOVO HIRES ARNOLD & PORTER TO LOBBY — Novo Nordisk, maker of blockbuster weight-loss drugs Ozempic and Wegovy, is doubling down on efforts to lobby Congress to allow Medicare to cover anti-obesity medications. The drugmaker hired law and lobbying firm Arnold & Porter to push lawmakers to reverse a ban on allowing Medicare to cover weight-loss drugs in its Part D program, Megan reports. Medicare Part D and most commercial insurers cover Ozempic only for the treatment of diabetes. The people: Recently retired Rep. Ron Kind (D-Wis.), who sponsored the bill to allow for coverage, joined Arnold & Porter in February. However, ethics rules bar him from lobbying his former colleagues in Congress for one year. The lobbyists working on the contract include Sonja Nesbit, who served as a senior HHS official during the Obama administration, and longtime GOP health care lobbyist Eugenia Pierson. Looking forward: Senate Majority Leader Chuck Schumer aims to bring a drug price package to the floor this year, but whether it will be a broad vehicle is unclear. Pharma Moves Abby Capobianco is leaving her position as a press officer in the FDA’s Office of Media Affairs to become a director of communications for U.S. vaccines at GSK. What We're Reading Bristol Myers Squibb is the latest drugmaker to sue the government over the Inflation Reduction Act’s Medicare drug negotiation program, CNBC’s Spencer Kimball reports. The lawsuit, the third in recent weeks, contends the program violates the First and Fifth Amendments. Document Drawer The FDA published on Tuesday its annual report on the state of pharmaceutical quality.   LISTEN TO POLITICO'S ENERGY PODCAST: Check out our daily five-minute brief on the latest energy and environmental politics and policy news. Don't miss out on the must-know stories, candid insights, and analysis from POLITICO's energy team. Listen today.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings This email was sent to rouf@idiot.cloudns.cc by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA Please click here and follow the steps to unsubscribe.