| 02 September 2022 | By Michael Mezher Welcome to another installment of This Week at FDA, your weekly source for updates big and small on FDA, drug and medical device regulation, and what were reading from around the web. The biggest news out of FDA this week was the agencys decision to authorize bivalent COVID-19 vaccine boosters from Pfizer-BioNTech and Moderna. On Thursday, a key Centers for Disease Control and Prevention (CDC) panel voted 13-1 in support of both modified boosters. On Wednesday, FDA amended the emergency use authorizations (EUAs) for both the Pfizer and Moderna vaccines to authorize the vaccine makers new bivalent compositions targeting the Omicron BA.4/5 subvariants and the original SARS-CoV-2 strain. The bivalent Pfizer-BioNTech booster is authorized for use in individuals 12 and older, while Modernas bivalent shot is authorized for adults 18 and older. FDA noted that the primary series will retain the original monovalent formula, though the monovalent boosters will no longer be offered to the age groups eligible for the bivalent vaccines. The following day, the CDCs Advisory Committee on Immunization Practices (ACIP) voted nearly unanimously to recommend the modified boosters, Stat reports. The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant. They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants, said CDC Director Rochelle Walensky. She noted that the agency expects to recommend bivalent boosters for other pediatric age groups in the coming weeks. Pfizer has said it plans to submit a request for its Omicron-adapted bivalent vaccine for the 5-11 age group early next month. In other regulatory news, Bloomberg Law reports that FDAs proposed rule to harmonize its regulations on human subject protection and institutional review boards with the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, has gone through Office of Management and Budget (OMB) review, clearing the proposal for publication. We also learned from Endpoints and the Los Angeles Times that a federal judge in California ruled against FDA in its case against the California Stem Cell Treatment Center (CSCTC). The ruling could upend FDAs efforts to reign in stem cell clinics offering unproven treatments. FDA ended a multi-year period of enforcement discretion for regenerative medicine products last year and has since stepped up efforts to bring such entities in compliance with its regulations. It has written dozens of untitled letters to companies offering various cellular-derived products that the agency feels should be subject to a biologics license application. Drugs & Biologics On Thursday, FDA announced a new pre-consortium partnership with the Critical Path Institute (C-Path) aimed at facilitating the development of drugs for patients with lysosomal diseases. The partnership will involve academic institutions, drugmakers and patient groups, and the effort falls under FDAs Accelerating Rare disease Cures (ARC) program. FDA also announced the approval of Sanofis Xenpozyme (olipudase alfa) as the first approved treatment for acid sphingomyelinase deficiency (ASMD) in the US. ASMD has a debilitating effect on peoples lives and there is a critical need to increase treatment options for patients who suffer from this rare disease, said Christine Nguyen, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDAs Center for Drug Evaluation and Research. The drug is an enzyme replacement therapy that reduces the amount of sphingomyelin accumulation in the liver, spleen and lungs. It received fast track, breakthrough therapy, priority review and orphan designation, and FDA awarded the company a valuable rare pediatric disease priority review voucher with the approval. Additionally, the agency posted new data on the impact of its Generic Drug User Fee Amendments (GDUFA II) science and research efforts in FY2021.

For generic products in development, FDA noted that the number of pre-ANDA meetings impacted by the agencys research increased from 92 meetings in FY2020 to 113 meetings in FY2021. Similarly, the number of controlled correspondences impacted by its research rose from 291 to 457 in the same time period. Some measures decreased; FDA said the number of product-specific guidances (PSGs) impacted by its research declined from 86 in FY2020 to 40 in FY2021. For products with an ANDA submission, most of the metrics declined or stayed about the same from FY2020 to FY2021. Medtech This week, the Center for Devices and Radiological Health identified several recalls as Class I recalls, the most serious type, including recalls for Integras CereLink ICP Monitor, certain Philips Respironics BiPAP Machines, Intera Oncologys Intera 3000 Hepatic Artery Infusion Pump and Hamilton Medical AGs Hamilton-C6 Intensive Care Ventilator. We also learned this week that a Philips Respironics will pay $24 million to address alleged false claims for its respiratory products, according to Reuters.

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This Week at FDA: ACIP signs off on bivalent boosters - Regulatory Focus