This Week at FDA: CDRH, CBER annual reports, OIG report on accelerated approval

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 released several reports, including annual reports for its device and biologic centers and a strategic agenda for its Rare Disease Innovation Hub, and a report by a government watchdog found issues with FDA’s accelerated approval program.

Both the Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH) released their annual reports for 2024 on Friday.

On the device side, CDRH Director Michelle Tarver called 2024 a “year of transition,” noting the departure of her predecessor Jeff Shuren and several new initiatives that launched last year, including a pilot to enhance medical device recall communications, the first meeting of its Digital Health Advisory Committee, and its Home as a Health Care Hub initiative. The center also said it authorized 120 novel devices in 2024, “on par with [2023’s] record setting number of authorization and among the highest in the history of our Center.”

In a separate statement, Tarver said that FDA needs new authorities to better safeguard the medical device supply chain, specifically calling on Congress to amend Section 506J of the Coronavirus Aid, Relief, and Economic Security (CARES) Act to require mandatory device shortage reporting outside of public health emergencies and to fully fund the center’s supply chain program.

CBER Director Peter Marks touted the approval of 17 biologics license applications (BLAs), 24 biological device applications, and 26 BLA supplements in 2024, as well as the center’s efforts toward the launch of the Support for clinical Trials Advancing Rare disease Therapeutics (START) pilot and the Rare Disease Innovation Hub.

FDA also unveiled its strategic agenda for the Rare Disease Innovation Hub, laying out its goals for the new program in 2025, including to further advance regulatory science for rare disease therapies, to enhance and strengthen coordination and alignment between the agency’s product centers, and to create a centralized point of contact for external partners.

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has released its report into FDA’s accelerated approval program. The report looked at a sample of 24 drugs approved under the pathway and found that in three cases, the agency’s use of accelerated approval raised concerns. According to OIG, in two of the cases, “FDA evaluated analyses not included in the sponsor’s original analysis plans” and in the other case, meetings between the agency and the sponsor were missing from the administrative file. For all three drugs that raised concerns, OIG noted that FDA approved the products over “concerns from its own reviewers and/or advisory committees.”

This week, FDA issued a final order to amend its color additive regulations to revoke the use of Red No. 3 dye in foods and ingested drugs; the order takes effect on 15 January 2027 for foods and on 18 January 2028 for drugs.

Drugs & biologics

Reuters reports that outgoing FDA Commissioner Robert Califf said that stronger laws and regulations are required to adequately protect consumers from the risks of compounded weight-loss drugs during a call with reporters on Thursday. In related news, Reuters reported that half of websites selling compounded weight-loss drugs fail to inform patients of their risks, according to a research letter published in JAMA Health Forum on Friday.

FDA has warned health care professionals not to use unapproved epinephrine nasal solutions made by PBI Labs or Endo USA. The agency said that some health care professionals have confused the products with FDA-approved injectable versions. The agency notes that nasal solutions are not required to be sterile, which could cause potentially life-threatening infections in some patients.

FDA announced it will host a webinar on 27 February to provide an overview of controlled correspondences for generic drug development. Additionally, it will host a virtual meeting on 13 March to discuss model master files (MMFs) to support modeling and simulation in generic drug development.

FDA is seeking input from stakeholders on the use of Type V drug master file (DMF) submissions for MMFs for generic drugs. Type V DMFs are used to submit FDA-accepted reference information, and the agency notes that these submissions can be concorporated by reference by other applicants with authorization by the DMF holder.

FDA has issued a notice in the Federal Register that it plans to refuse to approve Vanda Pharmaceuticals’ Tradipitant capsules, 85 mg, for treating gastroparesis after handing the company a complete response letter in September 2024. The notice lists five deficiencies the agency identified in the application, which FDA said should be addressed in a resubmission; however, Vanda informed the agency it wanted the application approved as-is and requested an opportunity for a hearing to petition its case.

FDA’s Oncology Center of Excellence issued a draft guidance this week on the development of drugs to treat or prevent chemotherapy-induced peripheral neuropathy in cancer patients.

The Center for Biologics Research and Evaluation (CBER) has issued a draft guidance with recommendations to reduce the risk of transfusion-transmitted malaria via blood or blood components. The guidance will supersede the agency’s 2022 guidance on the topic when finalized.

Medtech

This week, CDRH published its Accreditation Scheme for Conformity Assessment (ASCA) annual report for 2024. The center said it received 82 submissions that referred to ASCA in 2024, including 11 Q-submissions, 64 510(k)s, 2 de novo requests, 4 investigational device exemptions (IDEs), and 1 premarket approval (PMA). The figure represents a significant uptick in submissions under the program compared to the 51 submissions received in 2022 and 2023 combined.

On Thursday, FDA provided an update on the safety of neonatal incubators after raising concerns that some of the devices could emit airborne chemicals in 2023. The agency said that all new neonatal incubators on the market “do not demonstrate concerning levels of airborne chemicals and therefore do not need to be run for a week before clinical use.”

FDA issued another early alert under its recall communications pilot, this time announcing that Fresenius Kabi has issued a letter to some health care providers alerting them that its Ivenix Infusion System may need a software update to address a “potentially high-risk device issue.”

This Week at FDA: CDRH, CBER annual reports, OIG report on accelerated approval

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