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Presented by Biogen: 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 Biogen | With Katherine Ellen Foley, Annie Snider, Alice Miranda Ollstein and Megan R. Wilson. | | | — Some high school-aged teens will be able to get their Covid-19 booster shots before Christmas now that federal regulators have authorized them for Pfizer’s product. — FDA’s chief tobacco regulator to step down in April. Mitch Zeller has been in the position since 2013. — House Democrats and Republicans will release dueling reports on lowering drug prices as the Senate prepares to take up a massive social spending package. It’s Friday. Welcome back to Prescription Pulse. It’s National Influenza Vaccination Week, so here’s your friendly reminder it’s not too late to get your flu shot! Send tips and feedback 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). | | A message from Biogen: Having lost several family members to Alzheimer’s disease—including both of his parents, a grandfather, and an uncle—Greg understands from firsthand experience what his own diagnosis meant for both him and his family. Though his own life has changed dramatically, Greg has hope for future generations and others who are living with Alzheimer’s. Learn more about Greg’s story and Biogen’s commitment to those living with Alzheimer’s. | | | | | | REGULATORS ENDORSE PFIZER BOOSTER FOR SOME TEENS — FDA and CDC signed off Thursday on Pfizer and BioNTech’s bid to expand usage of their Covid-19 vaccine booster to 16- and 17-year-olds, Lauren writes. The decision came a little over a week after the companies made the request, and as the Omicron variant continues to spread worldwide. "Although we don’t have all the answers on the Omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against Omicron and other variants," CDC Director Rochelle Walensky said in a statement. The move also came a day after Pfizer and BioNTech announced early data suggesting that their booster can offer enhanced protection against the new strain, while the initial two-dose series may still shield recipients from severe disease. However, the data hasn’t been peer-reviewed. ARE THE KIDS ALRIGHT? — So how many American kids have gotten their Covid shots? The Kaiser Family Foundation dropped two reports this week showing that, after early peaks, demand for the vaccines among adolescents and younger children has slowed in recent weeks. About 16.7 percent of 5- to 11-year-olds in the U.S. had received at least one dose as of Dec. 5, with just 4.3 percent considered fully vaccinated more than one month after the jab was authorized for this age group. But the rate of vaccination slowed down before Thanksgiving, and, unsurprisingly, rankings in immunization rates for those kids mirror those for adults across most states. That means undervaccinated states like Mississippi, Tennessee and Wyoming have similarly low rates for kids and adults alike. A separate report found that vaccine uptake among adolescents also seems to have stalled in the last two months, with about half of parents surveyed saying they got their teens inoculated and 30 percent saying they won’t get their teens vaccinated. Notably, that study was conducted before the Omicron variant was publicly identified. FDA AUTHORIZES COVID PROPHYLACTIC FOR IMMUNOCOMPROMISED — Regulators signed off Wednesday on AstraZeneca’s monoclonal antibody cocktail for the prevention of Covid-19 in people 12 and up who are either immunocompromised and may not mount a sufficient immune response from the vaccines, or who have a history of severe allergic reactions to the Covid shots or any of their ingredients. One dose of the drug may be effective for up to six months. | | | | JOIN TUESDAY FOR A WOMEN RULE 2021 REWIND AND A LOOK AHEAD AT 2022: Congress is sprinting to get through a lengthy and challenging legislative to-do list before the end of the year that has major implications for women’s rights. Join Women Rule editor Elizabeth Ralph and POLITICO journalists Laura Barrón-López, Eleanor Mueller, Elena Schneider and Elana Schor for a virtual roundtable that will explore the biggest legislative and policy shifts in 2021 affecting women and what lies ahead in 2022. REGISTER HERE. | | | | | | | | FDA’S CHIEF TOBACCO REGULATOR TO STEP DOWN IN APRIL — Mitch Zeller, the director of FDA’s Center for Tobacco Products, plans to retire in April, Katherine reports. Acting commissioner Janet Woodcock announced his plans in an all-staff email on Wednesday. Zeller has been leading CTP since 2013, and is the center’s second director. During his tenure, CTP gained the authority to regulate e-cigarettes, and has ordered millions of flavored e-cigarettes off the market. CTP also authorized the first e-cigarette for sale, though it is still deciding the fate of products from several large market share holders, including Juul. FDA also announced plans to ban all menthol cigarettes and flavored cigars. It is slated to propose that rule officially the same month Zeller retires. “It has been an honor and a privilege to serve as CTP Center Director since 2013," Zeller said in a statement sent by the FDA. "The public health mission of the Center, to help reduce tobacco-related disease and death, remains vitally important. The strong leadership at FDA and the Center will ensure that this important work continues.“ Fond farewells: In her email to staff, Woodcock referred to Zeller as “invaluable and instrumental” to advancing public health in tobacco regulation. Former FDA commissioner Scott Gottlieb also had words of praise for Zeller. “Mitch saw the urgency of using FDA’s authorities aggressively to reduce death and disease from tobacco, and he had the patience to do the long and hard policy work to achieve these goals,” he told Katherine. “He was a trusted partner to me and is an effective advocate for the FDA’s mission.” What’s next: Woodcock told FDA staffers that there would be a formal search for a new director, and that Zeller would assist with the process. | | | HOUSE INVESTIGATORS TO UNVEIL COMPETING DRUG PRICING REPORTS AS SENATE PREPARES TO TAKE UP BBB — Democrats and Republicans will roll out different recommendations Friday morning for lowering prescription drugs costs as the debate over the social spending bill and its health provisions drags on, POLITICO’s Alice Miranda Ollstein and Megan R. Wilson report. Democrats will release their report — the result of a nearly three-year investigation based on stacks of internal documents from pharmaceutical companies — at a press conference at 8:30 a.m. attended by party leaders, including Speaker Nancy Pelosi. In a preview of her remarks provided to Alice, House Oversight Chair Carolyn Maloney said the report is aimed at “building the case for urgently passing the Build Back Better Act.” While Senate Democratic leaders have pledged to pass the bill before leaving Washington for Christmas, Sen. Joe Manchin remains skeptical of that timeline. More meetings with the parliamentarian that could threaten some of the Democrats’ drug pricing provisions will continue next week. Republicans plan to release a rival report on Friday. It is expected to claim that pharmacy benefit managers, not drugmakers themselves, are to blame for rising costs, and propose possible reforms — some of which Democrats support. | | | |   | | | | | | FDA POSTS MONTHS-OLD MDUFA MINUTES — Three sets of minutes describing MDUFA V negotiation meetings between the medical device industry and the regulatory agency held in May and June were posted by FDA this week. The two sides are supposed to transmit a deal to Congress by Jan. 15, but that deadline appears to be in jeopardy. A source close to the negotiations says the agency and industry are still not close to a deal. The two sides are scheduled to transmit a deal to Congress by Jan. 15, a deadline that appears to be in jeopardy. “That’s five weeks away, we’ve got the holidays in the middle there, and no additional negotiation meetings are currently scheduled,” the source said. “The timing is not looking great.” LAWMAKERS MEET WITH EPA’S REGAN TO DISCUSS ETHYLENE OXIDE REGS — Leaders of Congress’ bipartisan Ethylene Oxide Task Force met Wednesday with EPA Administrator Michael Regan to discuss the Biden administration’s path forward on the highly toxic cancer-causing chemical that has raised alarm in communities from Illinois to Georgia to Texas. According to a readout from Rep. Brad Schneider (D-Ill.), one of the task force’s co-chairs, panel members agree more ambient air monitoring is needed to pinpoint sources of the chemical, as well as stronger engagement with impacted communities. But Schneider also said in a statement that the task force “pushed” EPA to conduct a residual risk review for the chemical — an analysis that would presumably account for the far greater risk that EPA concluded in 2014 the chemical poses and could lead to stricter emission requirements. EPA’s inspector general has called for such a review, but acting air chief Joe Goffman has pushed back. An EPA spokesman said Regan told lawmakers the agency “is committed to protecting workers and communities from the serious health risks posed by emissions of EtO while safeguarding the supply of vital sterilized medical devices.” | | | | BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now. | | | | | | | | THERMO FISHER CLOSES $17.4B PPD DEAL — Thermo Fisher Scientific announced Wednesday it closed its $17.4 billion acquisition of clinical research service company PPD. | | | Johnson & Johnson has made several new appointments to its executive committee. Vanessa Broadhurst is now executive vice president for global corporate affairs; Bill Hait is now executive vice president and chief external innovation, medical safety and global public health officer; Mathai Mammen is executive vice president for pharmaceuticals and R&D; and Jim Swanson is executive vice president and chief information officer. The Healthcare Supply Chain Association named Todd Ebert permanent president and CEO. He was interim chief executive and served as president and CEO of the trade group from 2015 to 2019. | | | ‘PHARMA BRO’ COMPANY SETTLES DRUG PRICING SUIT — The Federal Trade Commission and states including New York and California reached a $40 million settlement Tuesday with Vyera Pharmaceuticals, once helmed by Martin Shkreli, over antitrust allegations, POLITICO’s Victoria Colliver writes. The company was accused of stifling competition by blocking generic versions of its drug Daraprim, which is used to treat the potentially fatal parasitic disease toxoplasmosis. | | | EU REGULATOR COULD AUTHORIZE OMICRON VACCINE IN 3 TO 4 MONTHS — The European Medicines Agency said Thursday that, if required, a new Omicron-targeted vaccine could be authorized for use in Europe next spring, POLITICO Europe’s Helen Collis reports. Marco Cavaleri, vaccines lead at the EMA, told a press briefing that the agency is engaging with vaccine manufacturers on their “plans for the development of a potential Omicron variant vaccine.” | | | The market failure of Aduhelm, a contentious Alzheimer’s drug from Biogen, sent the biotech company careening into internal turmoil and massive layoffs, Adam Feuerstein and Damian Garde write for STAT. | | | FDA updated its clinical outcome assessment compendium this week to encourage communication between drug manufacturers and researchers. | | A message from Biogen: When Greg received the devastating news that he had been diagnosed with Alzheimer’s, he thought about his family members whom he’d watched grapple with the disease. Stunned yet not surprised by the news, Greg’s first concern was his children. Like all of those living with Alzheimer’s or supporting someone with the disease, Greg’s life changed dramatically as a result of his diagnosis. Despite his own challenges, Greg says caregivers are “the real all stars.” As those who have been impacted by the disease know all too well, Alzheimer’s affects not only the patient, but often has implications for and takes a toll on loved ones. Biogen is learning from those who came before us and listening to patients and caregivers in order to pioneer new advances in neuroscience that bring hope to future generations. Learn more about Greg’s story and Biogen’s commitment to those living with Alzheimer’s. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
