This Week at FDA: New deputy commish for human foods, Califf talks about the future, meetings a go-go
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 we’re reading from around the web. This week, we learned about a new leader for the Human Foods Program, FDA Commissioner Robert Califf made news during an Alliance webcast, and the agency announced a slew of upcoming meetings.The biggest FDA news of the week is that the agency is hiring James “Jim” Jones, formerly of the Environmental Protection Agency (EPA), as the first deputy commissioner for its new Human Foods Program. As part of the move, the agency is also proposing a massive reorganization that will restructure its Office of Regulatory Affairs (ORA).
During a virtual chat with the Alliance for a Stronger FDA, Califf said the agency anticipates "a decade of tremendous change" and is taking a more "activist" approach to prepare for the future.
The Department of Health and Human Services (HHS) announced that it has awarded more than $1.4 billion to Project NextGen to develop new tools and treatments to fight COVID-19. The project is expected to cost $5 billion in total and is being coordinated by the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).
The Centers for Disease Control and Prevention (CDC) announced it is convening its Advisory Committee on Immunization Practices (ACIP) on 12 September to discuss updating COVID-19 vaccine recommendations. Politico reports that the ACIP meeting is expected to come only days after the FDA is expected to authorize updated COVID-19 vaccines. If the CDC endorses the FDA's decision, updated vaccines could be available to the public quickly thereafter.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet virtually on 5 October to discuss which influenza virus strains sponsors should include in their shots for the 2024 flu season.
Politico also reports that early next week the Biden administration is expected to list the first 10 prescription drugs for which is it negotiate directly with companies to set pricing for the Medicare program, as allowed by the Inflation Reduction Act.
Experts tell Biospace that they are skeptical of a voluntary FDA pilot program that would allow certain cancer treatments to come to market without a companion diagnostic. The laboratory-developed tests (LDT) that may be used instead of a companion diagnostic are effectively unregulated, according to experts interviewed by Biospace.
The Reagan-Udall Foundation and FDA are holding a two-day virtual meeting 12-13 September to discuss good clinical practice (GCP) for decentralized and pragmatic trials. The meeting will involve stakeholders from around the globe and hear from a wide range of researchers.
Drugs & Biologics
The FDA Compounding Quality Center of Excellence is holding a three-day annual conference starting 11 September. The aim is to discuss emerging trends and best practices in the compounding industry that have emerged over the past decade.
Sandoz's Tyruko (natalizumab-sztn) was approved by FDA. It is the first biosimilar to Tysabri (natalizumab) and is intended to treat patients with relapsing forms of multiple sclerosis (MS) and moderate to severe Crohn’s Disease (CD) for patients who don't respond well to other treatments.
Pfizer's Abrysvo (Respiratory Syncytial Virus Vaccine) was approved by FDA as the first vaccine of its kind. It is meant to help prevent lower respiratory tract disease (LRTD) and severe LRTD from respiratory syncytial virus (RSV) in babies whose pregnant parent was injected with the vaccine. It was already approved by the agency for those 60 and older for the same indication.
After its new drug application (NDA) was rejected twice by FDA for its diabetes combination product ITCA 650 (exenatide in DUROS device), Intarcia Therapeutics is getting a chance to make its case before the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). The agency has agreed to allow the alternative form of hearing, which is scheduled for 21 September. It has also opened a federal register docket for stakeholders to comment on the product and FDA's actions.
Medtech
The Center for Devices and Radiological Health (CDRH) has qualified another Medical Device Development Tool (MDDT) to its list. The center has added Accelerated Testing to Prove Long-Term Material Biostability to the list, bringing the number of qualified MDDTs to 14.
FDA issued a safety alert telling consumers not to buy Dr. Berne’s MSM Drops 5% Solution or LightEyez MSM Eye Drops – Eye Repair. According to the agency, consumers who have already bought the products should immediately stop using them. Regulators tested the eye drops and found bacterial and fungal contaminants that they say could lead to deadly infections.
Draeger Medical has initiated a class I recall for its Carina Sub-Acute Care Ventilators after it found polyether polyurethane (PE-PUR) contaminants in the airpath of its devices that could release a potential carcinogen, according to FDA. The company warned that children who use the device may suffer serious adverse events, including death.
MedPage Today reported that FDA's Circulatory Systems Devices Panel (CSDP) narrowly voted against approving Medtronic's Symplicity Spyral Renal Denervation (RDN) System to treat hypertension, citing concerns about the risks. The same panel, however, gave the thumbs up to ReCor's Paradise ultrasound renal denervation system for the same condition.
