This Week at FDA: Marks testifies on vaccine safety, FDA approves new drugs for frostbite, allergic reactions, and more

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, FDA’s Peter Marks testified about vaccine safety on the Hill, the agency announced several notable drug approvals, and the agency extended an invitation to drugmakers to participate in its Site Tours Program.

On Thursday, the House Oversight Committee’s Select Subcommittee on the Coronavirus Pandemic held the first in a two-part hearing series on federal vaccine safety systems and injury compensation programs that included testimony from Marks, director of the Center for Biologics Research and Evaluation (CBER). He testified alongside Daniel Jernigan, director of the Centers for Disease Control and Prevention’s National Center for Emerging and Zoonotic Infectious Diseases, and CDR George Reed Grimes, director of the Health Resources and Services Administration’s injury compensation program. According to Politico, lawmakers sparred over misinformation, vaccine approval timelines, and regulators’ response to safety issues.

Politico also reported this week that Marks said FDA may soon release its plans to withdraw approval for drugs granted accelerated approval when they are found to be ineffective using the agency’s new authorities under the Food and Drug Omnibus Reform Act.

This week, FDA issued several guidances, including one on data monitoring committees and another on when sponsors can charge for an investigational drug in a clinical trial.

FDA also published several draft and revised draft product-specific guidances that provide details on topics such as its expectations for designing bioequivalence (BE) studies depending on the product for abbreviated new drug applications (ANDAs). The draft and revised draft product-specific guidances that were announced are based on a 2010 guidance entitled, "Bioequivalence Recommendations for Specific Products."

After stakeholders asked for more time to comment on FDA's draft guidance on the use of master protocols in clinical trials of drugs and biologics research that replaces a pandemic-era guidance on the topic, the agency said it will extend the comment period until 21 March. The comment period was originally supposed to close on 20 February.

The Center for Drug Evaluation and Research (CDER) said it will continue its Regulatory Project Management Site Tours and Regulatory Interaction Program, also known as the CDER Site Tours Program, and is inviting drugmakers to participate. The training program, which takes several days, allows agency project managers to tour pharmaceutical facilities to get firsthand experience of the drug development process and interact with industry representatives.

FDA announced its reorganization of the Office of Digital Transformation (ODT) was approved by the Department of Health and Human Services in December. The organizational restructuring is intended to consolidate similar functions and resources to create more efficiencies within the agency.

Stat News reports that the Biden administration is providing another $515 million to the National Institutes of Health (NIH) RECOVER initiative to research long-COVID and look for treatment options for the debilitating condition.

Drugs & Biologics

FDA this week approved several drugs, including the first treatment for severe frostbite, Eicos Sciences Aurlumyn (iloprost). The agency also approved Genentech’s Xolair (omalizumab) as the first drug to reduce allergic reactions to multiple foods after accidental exposure in adults and children 1 year or older.

FDA also announced it had approved Iovance Biotherapeutics' Amtagvi (lifileucel) as the first cellular therapy for unresectable or metastatic melanoma. The cancer drug had received orphan drug, regenerative medicine advanced therapy, fast track, and priority review designations, and was approved under the agency's accelerated approval pathway.

Additionally, the agency approved Ipsen’s Onivyde (irinotecan liposome) in combination with oxaliplatin, fluorouracil, and leucovorin, for first-line treatment of metastatic pancreatic adenocarcinoma, and it approved Takeda’s Eohilia (budesonide) as the first oral treatment for eosinophilic esophagitis, Reuters reports.

In a new report, the Department of Health and Human Services (HHS) Office of Inspector General said that a provision of the 2021 Infrastructure Investment and Jobs Act that requires manufacturers of certain single-dose container or single-use package drugs to provide refunds for discarded drugs payable under Medicare Part B has no known impact on the licensure or marketing of biosimilars.

Sarah Ikenberry, senior communications advisor at CDER's Office of Therapeutic Biologics and Biosimilars, published a blog post this week about the agency's outreach efforts to patients and healthcare providers on biosimilars. She noted that there is hesitancy over using biosimilars that may be due partly to experience with the products and a lack of understanding about how the agency regulates them.

Medtech

Earlier this week, Masimo announced it received clearance from FDA to market its medical-grade MightySat Medical pulse oximeter for over-the-counter use. The company said it is the first FDA-cleared pulse oximeter that does not require a prescription.

FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee this week voted 13-1 in favor of Abbott Medical’s premarket approval application (PMA) for its TriClip G4 system for patients with severe tricuspid regurgitation, Medpage Today reports.

FDA said Philips is recalling its BrightView, BrightView X, and BrightView XCT imaging systems because the detectors may fall off, which could lead to a slew of potential physical injuries. The systems are Single Photon Emission Computed Tomography (SPECT) machines, and so far, there has been one reported incident with the machines, though no reported injuries or deaths.

FDA also announced Smiths Medical is recalling its Medfusion Model 4000 Syringe Pump because of problems with earlier versions of the onboard software. The devices are used to administer fluids such as blood, lipids, drugs, antibiotics, and therapeutic fluids, and the software failure could interrupt treatment or give the wrong therapy. So far, there has been one reported injury from the software failure but no deaths.

This Week at FDA: Marks testifies on vaccine safety, FDA approves new drugs for frostbite, allergic reactions, and more

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