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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 David Lim | With Katherine Ellen Foley | | | — Moderna is seeking full FDA approval of its Covid-19 vaccine, the second manufacturer to do so. — Demand for rapid Covid tests is plummeting, one company has told investors. — President Joe Biden’s budget calls for a funding boost for FDA after more than a year of a massive workload. It’s Wednesday, welcome back to Prescription Pulse. Looks like the WHO is taking a page from the old Atlantic hurricane naming system in shifting to the Greek alphabet to name Covid variants. Be sure to send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner ( lgardner@politico.com or @Gardner_LM) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). | | | MODERNA SEEKS FULL APPROVAL OF COVID SHOT — The company is seeking full FDA approval of its vaccine for use in those 18 and older, it announced Tuesday morning. That would allow the company to market the jab to consumers — and make it easier for institutions from schools to the military to require the shot. The manufacturer is seeking authorization to use the vaccine in teens 12-17 and is studying its use in children and potential booster shots — whether a third dose or a different formulation targeting key virus variants. The National Institutes of Health said Tuesday it’s kicked off a Phase I/II clinical trial to test booster doses of different Covid vaccines in fully inoculated adults. Participants will receive a single dose of the Moderna shot 12 to 20 weeks after their initial vaccination regimen. Moderna also said it has enlisted Thermo Fisher Scientific to help manufacture and package its Covid-19 vaccine. Thermo will use a factory in Greenville, North Carolina to help produce “hundreds of millions of doses” starting in the third quarter of 2021. “Thermo Fisher has been a critical partner in supplying raw materials for our COVID-19 vaccine and we are now pleased to further expand our relationship as an important manufacturing partner as well,” Moderna Chief Technical Operations and Quality Officer Juan Andres said in a statement. DEMAND FOR RAPID COVID TESTING PLUMMETS — Declining U.S. Covid-19 infections, expanding vaccine availability and recent CDC guidance advising against testing for people who are fully vaccinated are contributing to a rapid drop in demand for surveillance and screening testing, diagnostics manufacturer Abbott told investors Tuesday. "We've recently seen a rapid decline in COVID-19 testing demand and anticipate this trend will continue," Abbott CEO Robert Ford said in a statement. | | | | SUBSCRIBE TO "THE RECAST" TODAY: Power is shifting in Washington and in communities across the country. More people are demanding a seat at the table, insisting that politics is personal and not all policy is equitable. The Recast is a twice-weekly newsletter that explores the changing power dynamics in Washington and breaks down how race and identity are recasting politics and policy in America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear critical new voices that challenge business as usual. Don't miss out, SUBSCRIBE . Thank you to our sponsor, Intel. | | | | | | | | BIDEN ADMINISTRATION SIDES WITH FLORIDA ON DRUG IMPORTS — The administration late Friday asked a federal court to dismiss a lawsuit challenging a Trump-era rule allowing drug imports from Canada. The move effectively aligned Biden’s HHS with Florida and New Mexico, the two states that have thus far sought federal approval to buy drugs from Canada. Still, the administration’s argument against drug lobby PhRMA’s challenge was rooted in process — industry acted too soon, it said, because the rule hasn’t been officially implemented. “Any future implementation, if it were to occur, may not occur as Plaintiffs speculate,” the government motion said. “Meanwhile, nothing is required of Plaintiffs’ members.” | | | BIDEN SEEKS FDA FUNDING BUMP — The White House’s 2022 budget blueprint calls for a 5 percent funding increase for FDA — $3.6 billion in federal appropriations, a 10.7 percent increase over estimated fiscal 2021 levels, and $2.8 billion in industry user fees, or a 1.8 percent boost. The significant jump in proposed taxpayer funding drew plaudits from the Alliance for a Stronger FDA, which advocates for “adequate” appropriations for the agency in addition to the user fees it collects. The Biden proposal endorses legislation expanding FDA’s tobacco user fee program to cover e-cigarettes and other electronic nicotine delivery systems. It also proposes allowing Medicare to negotiate with drug manufacturers over the prices of their products, though the document doesn’t get into details about Biden’s plan. FDA: DO NOT USE LEPU MEDICAL COVID TESTS — Covid-19 antigen and antibody tests made by Lepu Medical Technologies should not be used because there “is likely a high risk of false results,” the FDA warned Tuesday in a safety communication. The tests — which were distributed to certain pharmacies and directly sold as at-home tests — are not authorized by the agency. | | | FTC TO HEAR OPENING ARGUMENTS IN ALTRIA/JUUL LABS TRIAL — The administrative hearing, which begins at 10 a.m., investigates whether Altria broke antitrust laws by buying up a 35 percent stake in Juul. It will be entirely virtual and open to the public. NIH BEGINS CLINICAL TRIAL FOR UNIVERSAL FLU VACCINE — On Tuesday, the National Institutes of Health launched a Phase I trial evaluating the safety of a single flu immunization designed to protect against multiple strains of the virus. NIH STUDYING IDEAL TIMING FOR GESTATIONAL DIABETES SCREENING — A study supported by the NIH hopes to enroll 2,150 pregnant people without diabetes to research how blood glucose levels change up to birth and what is the best time for gestational diabetes screening. | | | SCOTUS REJECTS J&J APPEAL AGAINST BABY POWDER JUDGMENT — Johnson & Johnson said Tuesday it will pay $2.5 billion to plaintiffs who alleged the company’s talc Baby Powder contains asbestos and causes ovarian cancer, after the Supreme Court rejected the company’s plea to review the judgment of an appeals court in Missouri, POLITICO’s Susannah Luthi reports. It’s a blow for the drug conglomerate, which had argued that decades of data doesn’t show a link between talc and ovarian cancer, citing FDA conclusions that slapping warning labels on “cosmetic talc products are scientifically unwarranted.” Justices Brett Kavanaugh and Samuel Alito didn’t take part in the deliberations. Alito owns J&J stock. But it isn’t clear why Kavanaugh recused himself, although The Associated Press reported that the justice’s now-retired father fought efforts to add warning labels to talc products or say it’s cancer-causing. | | | ABIOMED BUYS PRECARDIA — Massachusetts-based Abiomed announced Tuesday it acquired preCARDIA, a small medtech developing a catheter system for acute decompensated heart failure. | | | David Baumgart announced Tuesday on LinkedIn he is now a director of government relations for Thermo Fisher Scientific in Europe. iRhythm announced Tuesday CEO Mike Coyle has resigned “due to personal matters.” CFO Douglas Devine will step in as interim CEO while the company searches for a permanent replacement. | | | CDC Director Rochelle Walensky delivers keynote remarks today at noon during a virtual global health summit. | | | BROAD COALITION BACKS N.Y. VACCINE PRIVACY BILL — A coalition of advocacy groups is pushing the New York state Legislature to pass a bill that would strengthen privacy protections around vaccine passports, POLITICO Pro’s Amanda Eisenberg reports. The bill would prevent vaccine registry information from being used in criminal or immigration investigations. Third parties that collect data from the vaccine sign-up and administration process would also not be able to use the information for sales, marketing and offering of other services, without an opt-in from the patient. | | | GERMAN HEALTH MINISTER INVESTIGATED OVER COVID TESTING FRAUD — German Health Minister Jens Spahn is coming under fire after prosecutors confirmed they are investigating suspicious billing patterns at government-funded free coronavirus testing centers, POLITICO’s Barbara Moens writes. Broadcasters NDR/WDR and the Süddeutsche Zeitung newspaper reported that test centers had issued reimbursement claims for hundreds of tests that have not been carried out. Widespread free testing is an essential element of Germany's plan for reopening. People who have not been vaccinated have to display proof of a negative test before entering restaurants, museums and other public spaces. WHO LISTS CHINA’S SINOVAC VACCINE FOR EMERGENCY USE — On Tuesday, the global health organization cleared a second Chinese vaccine for widespread use. The decision opens up the Sinovac jab to be included in COVAX vaccinations, but the company has not yet agreed to participate in the program. | | | | SUBSCRIBE TO WEST WING PLAYBOOK: Add West Wing Playbook to keep up with the power players, latest policy developments and intriguing whispers percolating inside the West Wing and across the highest levels of the Cabinet. For buzzy nuggets and details you won't find anywhere else, subscribe today. | | | | | | | | After the FDA paused use of J&J’s vaccine in April over concerns about blood clots, many scientists noted that birth control pills carried a higher clot risk clots — stoking anger about the lack of safer birth control alternatives, The New York Times reports. At the height of the pandemic, all eyes were on top federal scientist Anthony Fauci. His emails from that time were a collection of queries, well wishes and requests for confidential briefings, the Washington Post reports. Children’s medical visits for routine ailments like bronchitis and the flu plummeted during the pandemic, but mental health emergencies among adolescents skyrocketed, STAT reports. Scientists should investigate the theory that SARS-CoV-2 spread after a lab leak — but they must do so without instigating anti-Asian hate, physician Leana Wen writes in a Washington Post opinion piece. | | | NIAID announced its Special Emphasis Panel Detection of HIV for Self-Testing will be convening a closed meeting to review grant applications on June 24. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
