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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 and Katherine Ellen Foley | With David Lim | | | — The CDC’s outside vaccine advisers today are expected to endorse third doses of Pfizer’s and Moderna’s Covid-19 shots for certain immunocompromised Americans. — Biden outlines plans to lower prescription drug costs for Medicare, but it will take more negotiating to get through Congress. — The medical device industry lays out its asks for its user fee amendment negotiations. It’s Friday, welcome back to Prescription Pulse. Perhaps there’s hope for concert-goers this year, after all (at least for outdoor show attendees). Be sure to tip your newsletter-tenders Lauren Gardner (lgardner@politico.com or @Gardner_LM) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). | | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | CDC PANEL TO VOTE ON THIRD DOSES FOR IMMUNOCOMPROMISED — The CDC’s vaccine advisory committee will meet this morning to review data, and then vote , on recommending third doses of mRNA Covid vaccines to certain immunocompromised patients who may not have mounted a sufficient immune response after the initial two-dose series. The recommendation would be couched as additional doses “as part of a primary series,” emphasizing that these wouldn’t be booster shots so much as doses these patients should receive to ensure adequate protection against the virus. The scheduled afternoon vote comes after the FDA officially amended its emergency use authorizations for the Pfizer and Moderna shots late on Thursday to approve additional doses for certain vulnerable groups, which is expected to include some cancer patients and solid-organ transplant recipients. A formal recommendation from CDC Director Rochelle Walensky is expected within days of an approval vote. Whither J&J? FDA’s anticipated move doesn’t apply to recipients of the single-dose Johnson & Johnson vaccine because, as Lauren and POLITICO’s Adam Cancryn noted this week, federal officials believe few immunocompromised patients opted for that shot, as it debuted months after the Pfizer and Moderna vaccines and the CDC advised those populations seek out the mRNA options. The CDC panel will also discuss “considerations for booster doses” at the meeting, but extra shots for the broader population aren’t on the vote docket. “Apart from the immunocompromised, we do not believe that others — elderly or not elderly — who are not immunocompromised need a [booster] vaccine right at this moment,” Anthony Fauci, the president’s chief medical adviser, said Thursday. “But this is a dynamic process — the data will be evaluated.” CDC: PREGNANT PEOPLE SHOULD GET VAXXED — The CDC took its strongest stance yet Wednesday on vaccinating pregnant and lactating people against Covid, advising those groups that the data on mRNA vaccines show no increased risks for miscarriage. The agency previously advised pregnant individuals that they were eligible for shots but may wish to consult with their doctors. Pregnancy can increase the risks of severe outcomes from Covid, and just 23 percent of pregnant people had received at least one dose as of July 31. HHS MANDATES VACCINATIONS FOR HEALTH CARE WORKERS — On Thursday, HHS Secretary Xavier Becerra announced that all front-facing federal health care employees must be vaccinated against Covid-19 — a policy that affects roughly 25,000 workers under a vast umbrella of agencies, POLITICO’s Adam Carcryn reports. Meanwhile, the Department of Veterans Affairs expanded its existing vaccination mandate to include most employees, contractors and volunteers who work in Veterans Health Administration facilities, which the White House estimates includes roughly 350,000 people. KIDS WITH COVID-19 ARE SWAMPING CHILDREN’S HOSPITALS AS SCHOOLS REOPEN — Pediatric hospitals are quickly becoming overwhelmed with patients with Covid-19 and RSV, another respiratory virus that can be dangerous for children, Dan Goldberg and Alice Miranda Ollstein report. Nearly 1,600 kids with Covid-19 were hospitalized last week, according to the CDC, which represents a new seven-day record and a 27 percent increase from the week before. And hospitals, already reaching capacity, expect the problem to get worse in the coming weeks. Unwavering opinions: Despite the increase of kids with Covid-19, Republican governors and state officials who have banned vaccine mandates, mask requirements and other public health tools to fight Covid-19 are sticking with those policies. Republican parents of school-aged children, too, are also steadfast: Almost 70 percent told pollsters from the Kaiser Family Foundation they continue to oppose school mask mandates. But it’s not only a partisan issue: 58 percent of all parents of children between 12 and 17 said they opposed mandating shots for those attending school in person. The good news? Nearly half of all parents with children eligible to receive vaccines either had their children vaccinated, or planned to do so in the near future. A word from POTUS: “I know there are a lot of people trying to turn a public safety measure — that is, children wearing masks in school so they can be safe — into a political dispute. But this isn’t about politics. It’s about keeping children safe,” President Joe Biden said Thursday at a press briefing on prescription drug prices. “To the mayors, school superintendents, educators, local leaders who are standing up to the governors politicizing masks' protection for our kids — thank you.” An update on a children’s trial: Moderna has nearly doubled the estimated enrollment for its under-12 study of its Covid vaccine to 13,275 participants, according to an update it submitted to the federal government this month. | | | MAJOR HEALTH GROUPS PUSH FDA TO REJECT FLAVORED E-CIGS — Several major health societies, including the Campaign for Tobacco-Free Kids, the American Lung Association, the American Heart Association and the American Academy of Pediatrics, sent a letter Wednesday to the FDA’s Center of Tobacco Products, urging it to reject the pre-market tobacco applications of all non-tobacco flavored e-cigarette or e-liquid products. They argue these products cannot protect public health, even with restrictions on sales to minors, based on “compelling real-world evidence that flavored products have fueled the epidemic of e-cigarette use, and resulting nicotine addiction, among young people.” The FDA has a Sept. 9 deadline to make a decision on nearly 6 million tobacco products that have been submitted via pre-market applications, but has already hinted it will likely miss the deadline. | | | BIDEN WANTS CONGRESS TO LET MEDICARE NEGOTIATE DRUG PRICES — The president outlined plans to lower prescription drug costs on Thursday, including giving Medicare greater power to negotiate with drug companies on costs, Sarah Owermohle reports. This call to action is similar to what he’s already endorsed in his 2022 budget proposal, and he also pressed Congress for the change during an April speech. On Capitol Hill: Biden’s proposals align with the debate happening on the Hill these days, and it’s not clear how it will settle. House Speaker Nancy Pelosi’s negotiation bill, H.R. 3, passed the chamber last year, but it will need more Senate support to make it to Biden’s desk. Lawmakers in the upper chamber are now figuring out how to nail down the details of their own drug pricing bill and shop it to skeptical colleagues. Also on the agenda: In addition to granting Medicare the ability to negotiate prices, Biden also advocated for limiting out-of-pocket costs and plans to import cheaper medications from Canada — even though HHS has not authorized any state importation plan since the Trump administration finalized the rule in September 2020. | | | INDUSTRY’S WISHES FOR MEDICAL DEVICE USER FEE AMENDMENTS — The medical device industry wants to increase its user fee agreement from the current $988.6 million to $1.117 billion in MDUFA V, according to a draft document of industry asks obtained by POLITICO. Industry largely wants to see these funds go toward pre-market review activities, whereas the FDA has said it wants some user fees to go toward increasing post-market surveillance for devices to monitor device safety. The draft document also calls for the carryover balance from past user fee agreements to go toward hiring more FDA reviewers, oversight supervisors, a “rainy day” fund to cover extraordinary circumstances like a government shutdown, and more. The FDA has said it plans to use those funds to redo its device center’s IT platform and adopt new digital technologies. The current iteration of user fees, which bring in hundreds of millions to the agency’s Center for Devices and Radiological Health, will run through the end of the 2022 fiscal year, but negotiations between both parties are heating up as they rush to get a draft agreement to Congress. | | | PBM LOBBY SUES HHS OVER TRUMP-ERA DRUG PRICE RULE — The Pharmaceutical Care Management Association filed a lawsuit Thursday against HHS, challenging a rule finalized toward the end of the Trump administration requiring disclosures of certain drug cost information to consumers. The group, which advocates for pharmacy benefit managers, is pushing back against the portion of the rule requiring group health plans and insurance issuers to publish historical net prices for prescription drugs. That “proprietary, highly confidential information,” PCMA argues, “is of no practical use to consumers, in a [machine-readable] format ... that no consumer could possibly understand” and undercuts PBMs’ power to negotiate price concessions from drugmakers. | | | Diagnostic Biochips has hired Nancy Palmer as vice president of marketing and community outreach. Ken Burdick and David King have been appointed to the board of directors of VaxCare, a health care technology company focused on vaccine management. | | | FLORIDA GOVERNOR PUSHES ANTIBODY TREATMENT AMID COVID-19 SURGE — As Florida sees its highest new Covid-19 case counts to date, Gov. Ron DeSantis said Thursday that the state will begin setting up mobile units to offer monoclonal antibody treatment to those battling Covid-19 who have not been hospitalized, reports POLITICO’s Gary Fineout. The treatment, manufactured by Regeneron, isn’t recommended for patients with severe Covid; instead, DeSantis said he intends these mobile sites to fill the “gaps” in areas where the treatment is otherwise unavailable. It is the governor’s first concrete action amid a recent surge in Covid infections in the state. He has rejected calls to implement any kind of mask or vaccination mandates that could slow the spread of the disease. | | | WHO ADDS THREE DRUGS TO COVID TREATMENT STUDY — The World Health Organization has chosen three drugs used to treat various conditions to study as possible Covid treatments that could lower the risk of death in hospitalized patients, POLITICO’s Ashleigh Furlong reports from London. Eighteen months into the pandemic, there are still no effective Covid therapeutics. | | | | Be a Policy Pro. POLITICO Pro has a free policy resource center filled with our best practices on building relationships with state and federal representatives, demonstrating ROI, and influencing policy through digital storytelling. Read our free guides today . | | | | | | | | Preview: Medical device cyber policies — FDA’s Acting Cybersecurity Director for medical devices, Kevin Fu, offered a preview of how the agency’s thinking about device cybersecurity is changing and the policies industry should expect to see in the next year. One significant change is that the FDA has begun to reject devices “based on cybersecurity concerns alone,” instead of issues related to product efficacy, safety or quality, Fu said at an event this week. Industry should also expect a final guidance document by the end of 2021 on the pre-market evaluation of device cybersecurity. Delta variant causes diagnostics shift for FDA — The Delta variant of the coronavirus is leading to shifting regulatory priorities, FDA’s top diagnostics regulator, Timothy Stenzel, told diagnostics companies this week. For example, just a few weeks ago FDA had said that companies could use frozen research samples due to a shortage of new Covid-19 cases with which to test their diagnostic tests. Now, companies should generally be able to test their diagnostics in patients with active cases. “There’s unfortunately a boatload of SARS,” Stenzel said, referring to SARS-CoV-2. He also said the FDA is prioritizing high-volume Covid tests and over-the-counter self-administered tests, but due to capacity constraints is generally not able to provide pre-application advice. | | | A report on pharmaceutical waste from the National Academies of Sciences, Engineering and Medicine that came down soft on drug companies was authored by researchers with millions of dollars of undisclosed industry funding, Christina Jewett from Kaiser Health News reports. The Atlantic’s Ed Yong explains the road to Covid-19 becoming endemic and what the world can do to lessen the amount of death it will take to get there. | | | FDA is requesting nominations for voting and nonvoting consumer representatives to fill advisory committee vacancies. FDA will hold a virtual Patient Engagement Advisory Committee meeting on Oct. 6. The agency is seeking public comment on issues related to FDA’s post-approval regulation of certain drug products approved in abbreviated applications before the current abbreviated new drug application (ANDA) process was established. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
