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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 David Lim and Lauren Gardner | Presented by Biogen | With help from Katherine Ellen Foley | | | — FDA is weighing whether to authorize an antiviral pill to prevent Covid-19 symptoms from worsening. But will it be a pandemic game changer? — The Biden administration wants private insurers to reimburse people for at-home Covid-19 tests. — A study of U.S. veterans found Moderna’s Covid-19 vaccine was slightly more effective than Pfizer’s. It’s Friday. Welcome back to Prescription Pulse. Washington, D.C., hasn’t reinstated an indoor mask mandate … but it has issued a new advisory encouraging people to wear masks inside. 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. | | | | | | FDA WEIGHS COVID ANTIVIRAL EUA AFTER PANEL DEBATE — Independent advisers to FDA voted Tuesday to recommend the agency authorize molnupiravir, an oral antiviral made by Merck and Ridgeback Biotherapeutics, for emergency use, positioning it to become the first at-home therapeutic for Covid-19 after nearly two years without any oral treatments. That sets up the agency to issue an emergency use authorization for the drug at any time. But the 13-10 vote was a squeaker, signaling the drug is not the panacea many would like to see on the market . Many advisory committee members said that, if other more effective treatment options — perhaps like Pfizer’s offering, which the company has said boasts a nearly 90 percent efficacy rate — with better safety profiles get the agency green light, FDA should consider revisiting the EUA for molnupiravir, should it get one. Who would take it: An EUA is expected to include more guidance on who exactly can and should be prescribed the drug — issues the advisory committee weighed in on but didn’t explicitly consider as part of their vote. How detailed FDA gets will factor into the amount of discretion providers can use when considering the drug for Covid-positive patients. What your Rx PULSE authors are looking out for is who exactly will be considered part of the universe of “high-risk” individuals: Those with the specific underlying health conditions studied during the drug trial, or will a broader list akin to the CDC’s on who’s most at risk for severe Covid be considered? Will it be limited to unvaccinated individuals? How about vaccinated people who are immunocompromised? How much of a factor will age be? Another major question is how much FDA will wade into the thorny issue of whether to restrict the drug’s usage in pregnant and nursing people. Panel members seemed to be open to giving health care providers the ability to prescribe the drug to pregnant people only when the benefits clearly outweigh the risks, while generally discouraging its use in that population. But the pill’s effects on pregnant rats in lab tests made many uneasy. “There's no circumstance in which I would advise a pregnant woman to take this drug,” said James Hildreth, the president of Meharry Medical College in Nashville. Whither monoclonal antibodies? The committee and other experts largely agree that, in an ideal world, high-risk Covid patients would receive monoclonal antibodies over molnupiravir, given their effectiveness at preventing severe outcomes. But an oral medication is much easier to make and dispense; plus, with Omicron’s rise, the antibody cocktails may not pack as much punch against the highly mutated variant. One monoclonal antibody maker, GlaxoSmithKline, announced Thursday that early data shows its treatment retains activity against critical mutations in the Omicron variant. BIDEN: PRIVATE INSURERS SHOULD PAY FOR AT-HOME TESTS — The Biden administration announced Thursday it plans to issue guidance by mid-January directing private insurers to reimburse beneficiaries for at-home tests they submit receipts for — a change in policy that would cover more than 150 million Americans. The forthcoming policy change will not be retroactive, meaning people will not be able to obtain reimbursement for at-home tests they already purchased, according to a senior administration official. It is also unclear whether limitations will be placed on the number of at-home tests individuals can submit for reimbursement. Early testing and detection will be crucial to deploying a drug like molnupiravir, which patients must start within five days of symptom onset. It’s unclear, though, whether doctors and pharmacists will be able to rely on at-home positive tests to prescribe the drug. PFIZER, BIONTECH SEEK EUA FOR COVID BOOSTER — The mRNA vaccine partners asked FDA this week to expand its EUA for Covid boosters to include 16- and 17-year-olds, Lauren writes. The ask comes just weeks after external advisers to CDC and FDA pushed back on allowing broad booster use in younger people given the lack of safety data on additional doses for them. STUDY: MODERNA SHOT SLIGHTLY MORE EFFECTIVE THAN PFIZER’S — A study of U.S. veterans’ electronic health records showed that Moderna’s vaccine was slightly more effective at preventing Covid-19 than Pfizer’s product. Researchers reviewed the data at two points in the year when Alpha and then Delta were the predominant variants. HELLO MORE FREQUENT COVID-19 PRESS BRIEFINGS? — Top Biden health officials are scheduled to hold another Covid-19 press conference today at 11 a.m. EST. | | | | DON’T MISS CONGRESS MINUTES: Need to follow the action on Capitol Hill blow-by-blow? Check out Minutes, POLITICO’s new platform that delivers the latest exclusives, twists and much more in real time. Get it on your desktop or download the POLITICO mobile app for iOS or Android. CHECK OUT CONGRESS MINUTES HERE. | | | | | | | | LABS, DIAGNOSTIC MAKERS PRESS CONGRESS TO DELAY PAMA CUTS AGAIN — A diverse collection of industry groups asked congressional leaders Thursday to include a one-year delay to 2022 Medicare Clinical Lab Fee Schedule cuts and the next round of private payer data reporting in a year-end legislative package. The cuts, intended to help bring Medicare reimbursement for lab tests in line with what private insurers pay, are scheduled to take effect Jan. 1, 2022. “While we are grateful that Congress delayed the implementation of CLFS cuts in 2021 as part of the Coronavirus Aid, Relief, and Economic Security Act, we urge you to extend this delay — for both the 2022 cuts and the next private payer data reporting period — as the Public Health Emergency has not ended, and laboratories must continue to respond,” The American Clinical Laboratory Association, American Hospital Association, AdvaMedDx and others wrote in the letter. | | | FDA LAUNCHES PACLITAXEL DEVICE INFO WEBPAGE — FDA on Thursday launched a website convening information about what paclitaxel-coated balloons and stents are on the U.S. market, efforts to understand the devices’ safety and the agency’s recommendations to health care providers. “The FDA continues to evaluate and provide the latest information regarding the potential for increased risk for late mortality after use of paclitaxel-coated balloons and paclitaxel-eluting stents to treat PAD in the femoropopliteal artery,” FDA’s new webpage states. | | | ADVIL ADDS WARNING LABELS FOR PREGNANT PEOPLE — The FDA cleared additional warning labels for Advil Allergy & Congestion Relief and Advil Allergy Sinus . The additional warning states the pills could cause dangers to the unborn child or delivery complications if taken by individuals 20 weeks pregnant or more. | | | |   | | | | | | OMICRON DETECTED IN CALIFORNIA, MINNESOTA, MORE STATES — California health officials announced Wednesday that a person in San Francisco tested positive for the Omicron variant earlier in the week, POLITICO’s Erin Banco, David Lim and Adam Cancryn report. The individual had been experiencing mild symptoms and was fully vaccinated, although possibly not boosted, and had traveled to South Africa recently. On Thursday, the Minnesota and Colorado public health departments reported two more Omicron cases. In both cases, individuals had been vaccinated and experienced mild symptoms. And in New York, five more cases of Omicron were identified, Gov. Kathy Hochul told reporters late Thursday. | | | GERMANY PLACES LOCKDOWN ON UNVACCINATED PEOPLE — The German government and the leaders of the country’s 16 states on Thursday imposed a lockdown on people not vaccinated against coronavirus, reports POLITICO EU’s Laurenz Gehrke. The restrictions, put in place to decrease new infection rates, include some for vaccinated adults as well. Private gatherings can now involve only a maximum of two unvaccinated individuals from one household while nonessential shops will be restricted to the vaccinated and those who have recovered from Covid-19. | | | | 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. | | | | | | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA regulators talk impact of Omicron variant on tests — The FDA’s top diagnostics officials are monitoring the impact of the Omicron variant on authorized tests for Covid-19, regulators said at a Town Hall meeting this week. Tim Stenzel, the FDA’s top diagnostics regulator, said the agency is not currently aware of any test that is negatively impacted, but emphasized that developers should conduct evaluations of their products. FDA published guidance on viral variant monitoring in February 2021 laying out performance testing expectations for Covid-19 tests and diagnostics. Overall, the FDA recommended a specific series of evaluations for developers of molecular diagnostics that are intended to ensure that a test’s performance will not drop by 5% below its performance as authorized or fall below the performance threshold outlined in the Emergency Use Authorization templates. New FDA guidance on use of real-world data — The FDA this week released a new draft guidance document on the use of data obtained from clinical registries. Real-world data (RWD) refer to data collected from outside of a clinical trial, such as insurance and medical claims data. They may also be collected from clinical registries – organized systems that collect data in a standardized format for a specific population. Registries are often used to track health outcomes for specific conditions or for specific medical procedures. FDA’s guidance explains how medical product developers can assess a clinical registry’s “fitness-for-use” in regulatory decision-making for new indications for use for an already approved product, including discussions of what attributes a registry should have that can support the relevance and reliability of the data. Further, the agency lays out considerations for linking data in a registry to other sources of RWD (e.g., claims, EHR, digital health technologies, other registries) and best practices for submitting these data to the FDA. | | | Biden’s pick to lead FDA has asked acting commissioner Janet Woodcock to stay on in a leadership role, Nicholas Florko reports for STAT. Trump’s “America First” policies in the pandemic’s early days contributed to a global delay in Covid-19 vaccine donations and other aid to low- and middle-income countries, Banco reports. BARDA issued medical supply manufacturing contracts to dozens of facilities that fell below FDA standards, Marisa Taylor found in an investigation for Reuters. | | | FDA on Thursday requested nominations for people to serve as voting members and nonvoting industry representatives of the National Mammography Quality Assurance Advisory Committee. FDA announced Wednesday it is still monitoring biocompatibility concerns “associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium.” | | 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 | | | | |  |
