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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim and Lauren Gardner | With Katherine Ellen Foley, Rachel Roubein and Emily Martin. | | | — The U.S. will send about 75 percent of its next batch of Covid shot donations to COVAX, with the rest going directly to allies and priority regions. — The head of CMMI suggested a Trump-era policy to link Medicare drug payments to lower costs abroad won’t stay in its current form. — FDA is expected to make a decision on Biogen’s controversial Alzheimer’s drug aducanumab by Monday. It’s Friday, welcome back to Prescription Pulse. If you’re thinking of testing out any of the myriad cicada recipes floating around the internet, FDA wants you to make sure anyone partaking in those treats doesn’t have a shellfish allergy. 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). | | | | 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. | | | | | | | | WHITE HOUSE UNVEILS VACCINE DIPLOMACY PUSH — The Biden administration divulged its plan Thursday to allocate the first 25 million Covid vaccine doses it’s promised to help low- and middle-income nations fight the pandemic, POLITICO’s Erin Banco reports. The donations are being drawn from the U.S. stockpile of Pfizer, Moderna and Johnson & Johnson doses. The COVAX donations will be routed to countries in Africa, Central and South America, and South and Southeast Asia. Six million vaccines will go directly to Canada, Mexico, Ukraine and areas of the Middle East. Were you going to use that? The administration also is weighing whether to donate states’ unused vaccine vials before they expire, writes Erin, Adam Cancryn and Rachel Roubein. Some doses are set to expire by the end of the month, meaning the receiving countries would need to get them into people’s arms quickly. FDA probes contamination risks in AZ, J&J jabs: Drug regulators have asked AstraZeneca and J&J to examine any potential health risks from minor cross-contamination of their Covid vaccines, Erin reports. FDA is expected to soon announce whether the doses, manufactured by Emergent, are safe for use, and some of the doses in question were already sent to Canada and Mexico. | | | OUTLOOK UNFAVORABLE FOR KEY TRUMP DRUG POLICY — The CMS Innovation Center is examining a Trump-era policy to link Medicare payments for medicines to lower prices paid abroad. But CMMI head Liz Fowler indicated that the policy wouldn’t remain as is, POLITICO’s Rachel Roubein reports. “I don’t know that it’ll take that form,” Fowler said at a Health Affairs event. One reason is that a federal court blocked Trump’s most-favored nations drug pricing rule, which was set to go into effect Jan. 1. — Fowler added there were “some procedural hurdles that the agency skipped on its way to publishing,” and noted that she’d like to see whether Congress passes any new drug policies. | | | WHAT TO WATCH FOR: FDA’S DECISION ON ALZHEIMER’S DRUG — FDA is slated to make a final decision Monday on Biogen’s controversial Alzheimer’s drug aducanumab. If approved, it would become the first new treatment for the disease in nearly two decades. A reputation at stake : Aducanumab has been one of the most disputed drugs in the pipeline for the last few years. It’s a monoclonal antibody that binds and clears amyloid in the brain, which is thought to be one of the causes of cognitive decline in Alzheimer’s patients. Yet in March 2019, Biogen halted its late-stage clinical trials due to an early signal that the infusion wasn’t benefiting participants. Just seven months later, Biogen said it had re-analyzed its data, including an additional three months that had been collected. The company worked with FDA to submit aducanumab for approval using updated data points in June 2020. In November 2020, an independent advisory committee voted overwhelmingly against aducanumab’s approval, citing a lack of significant evidence. Advocacy groups like the Alzheimer’s Association have endorsed the approval of the drug as another option for the 5.8 million U.S. Alzheimer’s patients. But other experts fear that if the drug is approved without more data demonstrating its effectiveness, the agency’s independence will appear compromised. “They're kind of damned if they do and damned if they don't,” James Boiani, a lawyer who specializes in advising pharmaceutical companies working with the FDA, told POLITICO. DRUG SUPPLY CHAIN GUIDANCE — On Wednesday, FDA released final guidance for drug manufacturers to improve their supply chains. By November 2023 companies will be required to put detailed identification information via a barcode on all drug packaging to trace products back to their manufacturing site and batch. FDA also issued new guidance for reporting suspicious or counterfeit drug products. FDA RECRUITING SENIOR PRESS OFFICER — FDA’s media office is hiring for a permanent Assistant Commissioner for Media Affairs, a job opening posted Thursday reveals. Michael Felberbaum has been serving as the agency’s Acting Assistant Commissioner for Media Affairs since August 2020. WHITE OAK WATCH — Biden has spent 135 days in office without nominating a permanent FDA commissioner. | | | FDA, MEDTRONIC TELL DOCTORS TO STOP USING HEART PUMP — FDA and Medtronic alerted doctors Thursday to stop implanting a pump designed to improve heart function after receiving reports of 14 deaths and 13 cases of patients having to get the device removed. More than 100 complaints have been filed over the Medtronic device, the HeartWare Ventricular Assist Device System. In some cases, the pump failed to restart when stopped or restart was unexpectedly delayed. “We have been carefully monitoring the adverse events associated with this device and support its removal from the marketplace,” said Bram Zuckerman, director of the FDA’s Office of Cardiovascular Devices. Medtronic said it is stopping sales and distribution of the device, which was the subject of a recall late last year, and will develop a support program for patients with the device. FDA FLAGS ISSUES AT ITALIAN DEVICE STERILIZER — Italian medical device sterilizer Steril Milano falsified sterilization certificates for many FDA-regulated products dating back to 2016, the agency announced Wednesday. It is unclear how many devices in the U.S. were processed by the Steril Milano Reggiolo and Monza ethylene oxide facilities, but FDA believes 97 medical device manufacturers may be impacted. An agency official told POLITICO the agency is working with foreign governments and other U.S. agencies “to evaluate the scope of medical devices that may be impacted.” FDA recently issued an import alert on all devices that were processed by the facilities. No reports of patient harm have been tied to the sterilizer, but 10 firms have already voluntarily recalled devices. Steril Milano closed its ethylene oxide facilities in March and is no longer processing medical devices. | | | ORGANON SPINS OFF — Merck announced today that Organon, a spinoff focusing on women’s health and biologics, is now fully independent. | | | Amy Abernethy has been appointed president of Verily’s clinical research business. She joins the Alphabet company after serving as principal deputy commissioner of food and drugs at the FDA and as the agency’s acting chief information officer. Conor Sheehey is joining the GOP Finance Committee staff as a health policy adviser. He previously was legislative director for Sen. Tim Scott (R-S.C.). Illumina Chief Medical Officer Phillip Febbo announced on Twitter Thursday that he is joining the board of the Reagan-Udall Foundation for the FDA . | | | NY COUNTIES SUE MCKINSEY OVER 'TURBOCHARGING' OXYCONTIN SALES — New York City and 21 other counties are suing consulting firm McKinsey & Co. for its role in contributing to the opioid epidemic, POLITICO Pro’s Amanda Eisenberg reports. The lawsuit alleges that McKinsey "played a major role in crafting and implementing" deceptive marketing strategies to encourage further use of OxyContin, a drug developed by Purdue Pharma. The company is owned by the wealthy Sackler family, which has been at the center of controversy regarding the sale and popularity of opioids. The consulting firm has admitted to wrongdoing and paid fines in 49 states and five territories for its predatory behavior, according to the brief. | | | U.K. IN TALKS FOR ASTRAZENECA VACCINE AGAINST SOUTH AFRICAN VARIANT — The U.K. Health Secretary said the government is in talks with AstraZeneca to buy vaccine doses that are designed to protect against the variant first detected in South Africa, POLITICO EU’s Helen Collis reports. ONTARIO ENDORSES SECOND DOSE ‘MIXING’ — The Ontario government aligned itself with Canada’s National Advisory Committee on Immunization Thursday, advising residents who already got their first AstraZeneca jabs that they may opt to receive the Pfizer or Moderna vaccines for their second dose. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for the FDA. FDA’s diagnostics team says the staff “surge” is over — The FDA’s top diagnostics regulators told industry participants at a town hall meeting this week that the agency is finally ending a staff “surge” that had pulled in FDA employees from other medical device divisions to deal with a massive backlog of diagnostics applications for emergency use. According to FDA’s Timothy Stenzel, the director of its Office of In Vitro Diagnostics and Radiological Health (OHT7), the office is now “clearing applications weekly at the same rate that we’re receiving them.” The announcement is likely good news for the device industry, which may see faster reviews for other product types. Discussions about regulation of LDTs are ongoing — At the same meeting, diagnostics officials also said that discussions between FDA and HHS about the regulation of laboratory-developed tests are ongoing. “There’s not a whole lot that we can say at this point about LDTs, [as] that is still an issue that we’re working through,” said Toby Lowe, associate director for regulatory programs within OHT7. “But we do still have the guidance document out that discusses LDTs, as well as the HHS statement from last year,” Lowe said, referring to a policy that stripped the FDA of the authority to regulate LDTs except on a voluntary basis. Congress is currently considering potential changes to the regulation of LDTs, including the VALID Act, which would establish a unified framework for both LDTs and In Vitro Diagnostic tests. | | | | 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. | | | | | | | | The EU, Canada, Australia, Switzerland and Israel have signed deals with Pfizer and Moderna to get hundreds of millions of Covid-19 vaccine doses and boosters over the next two years, furthering a divide between rich and poor countries, the Wall Street Journal reports. The pandemic may have solved the problem of flu viruses continually evolving — or at least made flu’s diversity more manageable — with evidence that two strains may have disappeared, STAT News reports. The idea that Covid-19 could have leaked from a Wuhan, China, lab was written off as a conspiracy throughout 2020, but debate has reignited in recent weeks. Vanity Fair takes a deep dive. | | | FDA issued draft guidance for testing drug products to be administered through feeding tubes. Comments are open through Sept 2. The National Advisory Committee on Occupational Safety and Health announced its next public meeting will be on June 22. NIAID announced its Special Emphasis Panel for Integrated Preclinical/Clinical AIDS Vaccine Development Program will convene for a closed meeting on June 30. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
