This Week at FDA: Califf faces House Oversight committee, diversity plans on the horizon, 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 Commissioner Robert Califf asked House lawmakers for new authorities to address public health issues, and we learned a much-anticipated clinical trial diversity guidance is under review by the White House.

During a House Committee on Oversight and Accountability hearing on Thursday, Califf spoke broadly about supply chain vulnerabilities, reversing the decline in US life expectancy, accelerating the development of treatments for rare diseases, and the agency's reorganization efforts. Califf repeated his call for additional authorities from lawmakers, such as the ability to require product shortage notifications from manufacturers.

While several Republican lawmakers criticized FDA's response to the COVID-19 pandemic, Democrats argued that the agency needs more authorities to be effective. "Congress must ensure that FDA is empowered to rely on the facts rather than bend to the will of people pushing an ideological agenda,” said Ranking Member Jamie Raskin (D-MD), during the hearing.

One notable comment from Califf was that many drug shortages are tied to inexpensive generic drugs being discontinued because it doesn’t make financial sense for the manufacturer to keep making them. The same day, the American Society of Health-System Pharmacists released a report stating that ongoing and active drug shortages are at their highest level since they began tracking the data in 2001. For comparison, there were 220 drugs on the shortage list in the fourth quarter of 2021, and that number has steadily grown to 323 in the last quarter of 2023.

In December, FDA failed to meet a Congressional deadline to publish guidance on diversity plans to improve enrollment of participants from underrepresented populations in clinical studies. The guidance is currently under review by the White House Office of Management and Budget (OMB) and could be released shortly; however, our colleagues at AgencyIQ report that the impending guidance could be released as a revised draft document, instead of a final version.

FDA announced it will host its hybrid Regulatory Education for Industry (REdI) Annual Conference 2024 starting 29 May in College Park, MD, near its White Oak headquarters. The meeting will have three tracks for attendees depending on whether their primary area of interest is drugs, devices, or biologics.

FDA also announced it will hold a virtual public meeting on 6 June to discuss how it has handled its finances based on revenue collected through the drug, biosimilar, and generic drugs user fee programs. The agency plans to discuss its 5-year user fee plans and its progress to ensure resources are being used in accordance with what was negotiated with the medical industries.

As required under the 21st Century Cures Act, FDA has updated its Susceptibility Test Interpretive Criteria web page. The agency has the authority to identify susceptibility test interpretive criteria and is required to publish them annually, which may be used by antimicrobial susceptibility testing device sponsors in their premarket applications.

Drugs & Biologics

FDA's Oncologic Drugs Advisory Committee (ODAC) met on 12 April to discuss using minimal residual disease (MRD) as an endpoint in multiple myeloma clinical trials. The panelists unanimously agreed the available data supports using MRD as an endpoint and generally agreed that it could be a major opportunity to accelerate drug development, especially in frontline settings. However, there was some concern about evaluating toxicity and quality of life in clinical trials and concern that emphasis on early endpoints could decrease emphasis on later endpoints and overall survival.

The Center for Biologics Evaluation and Research (CBER) announced its Rare Disease Endpoint Advancement (RDEA) Pilot Program is now open to participants until 30 June. The program is intended to help advance rare disease drug development by allowing sponsors to work with FDA on developing efficacy endpoints.

Medtech

Over the past year, FDA has shown increasing frustration with how Dutch medical device company Philips has handled a class I recall of its continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines, and ventilators after reports that sound-dampening polyester-based polyurethane (PE-PUR) foam in the devices could break apart and be breathed or swallowed by users. This week, a Pennsylvania court ordered Philips to stop making the machines in the US until they resolve the manufacturing issues.

Last month, the FDA published a statement warning consumers not to use certain Chinese-made plastic syringes and issued warning letters to three manufacturers for failing to meet manufacturing requirements, including Jiangsu Shenli Medical. At the time, FDA said it was still okay to use 5 mL Luer lock syringes; however, now the agency says consumers should stop using all plastic syringes from Jiangsu Shenli Medical, including 5 mL Luer lock syringes.

As part of its efforts to monitor the long-term side effects of Bayer's permanent birth control device Essure, FDA updated its webpage for Essure patients and healthcare providers with updated postmarket study information. The agency also updated its webpage on problems reported with the device with additional medical device reports (MDR).

FDA announced it has taken several steps to better understand the safety and effectiveness of surgical mesh mini-slings, which are shorter versions of mid-urethral slings used to treat female stress urinary incontinence (SUI). Besides requiring long-term follow-up studies, the agency also completed a literature review and concluded that mini-slings perform comparably to mid-urethral slings, and the agency's recommendations remain unchanged.

16 Bit announced that the FDA has granted de novo marketing authorization for its Rho artificial intelligence/ machine learning (AI/ML) software, which screens for osteoporosis by looking for low bone mineral density (BMD) on X-ray images. The company noted the software received Breakthrough Device designation in 2021 and was the first FDA-authorized product of its kind to evaluate low BMD.

This Week at FDA: Califf faces House Oversight committee, diversity plans on the horizon, and more

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