This Week at FDA: Government shutdown averted, FDA updates device standards, 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, Congress narrowly averted a government shutdown and FDA published an update to its recognized conformity standards for medical devices.

President Joe Biden signed a short-term funding on Friday, narrowly averting a partial government shutdown that would have caused FDA to furlough a significant percentage of its staff. CBS reported that congressional leaders reached a last-minute government funding extension deal on 28 February. They extended four funding bills until 8 March that were due to expire on 1 March and extended other funding bills to 22 March.

FDA published an updated list of recognized standards that sponsors can use to conform to in their premarket applications. The agency said the new modified list includes new, withdrawn, corrected and revised consensus standards. Most of the changes are for standards that have been withdrawn and replaced with newer versions.

The Reagan-Udall Foundation and FDA announced they are hosting a public workshop on 13 May at FDA’s White Oak campus to discuss using registries and natural history studies to develop treatments for rare disease. The event is intended to draw researchers, industry representatives, and patient advocates to discuss the collection of registry and natural history data that meet regulatory requirements and how the data can be used in regulatory decisions.

On 16 May, FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) is set to meet virtually to discuss what strains to include in the 2024-2025 formula for COVID-19 vaccines. Members of the public who want to make a formal oral presentation at the meeting need to submit their request to FDA by 1 May.

Per- and polyfluoroalkyl substances (PFAS), which are widely used in medical devices, have been associated with an increased risk for cancer and other negative outcomes, and recent plans to phase them out in Europe have raised alarm bells in the medtech industry. This week FDA said that the chemicals are no longer being sold in the US in food packaging, which should significantly reduce their risk from dietary sources such as fast-food wrappers and microwave popcorn bags. They are still authorized for limited use in cookware, food packaging, and food processing equipment.

FDA responded to an article in the Journal of the American Society of Plastic Surgeons that analyzed the increased risk of lymphoma from breast implants based on their surface type and provided recommendations on when it is appropriate to remove the implants to reduce cancer risk. The agency said breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) cases are uncommon in the US, given that textured implants are less common here, and recommended against removing implants in asymptomatic patients.

FDA said it has received questions from healthcare providers about whether it oversees fresh allograft heart valves used in partial heart transplantations. The agency stated that if the fresh allograft heart valves comply with its tissue regulations, they are regulated under its human cells, tissues, and cellular and tissue-based products (HCT/P) by the Center for Biologics Evaluation and Research (CBER).

Drugs & Biologics

FDA published a final guidance on the Technical Conformance Guide used by drugmakers when they submit reports detailing the amount of each listed drug they manufacture, compound, or process for the market as required under the Coronavirus Aid, Relief, and Economic Security (CARES) Act to mitigate supply chain issues. More specifically, it details how first-time CDER NextGen Portal users can submit reports, different methods for submitting the reports through NextGen, and the data elements they need to include in their reports.

Last week, FDA announced it has withdrawn approval for Oncopeptides' Pepaxto (melphalan flufenamide), which was previously granted accelerated approval to treat multiple myeloma in combination with dexamethasone. The agency said a confirmatory study found the drug did not meet its threshold for clinical benefit as well as safety and effectiveness. It also noted that this was the first time FDA has used new amended authorities under the 2022 Food and Drug Omnibus Report Act (FDORA) to withdraw drugs with accelerated approval.

Several researchers published an article in the Journal of American Medical Association (JAMA) about vaccine misinformation and hesitancy, noting FDA's Vaccine Adverse Event Reporting System (VAERS) has become a source used by anti-vaxxers to make their make their flawed arguments. They made recommendations on how to address the issue, including renaming VAERS to the Vaccine Safety Sentinel to better explain its purpose, and providing more contextual and summary information.

People should not use QUICK Rheumatism Capsule, Tiger Wang Biaod, or SNAKE BONES Anti-Rheumatic Capsule marketed online and in stores as treatments for rheumatism, according to FDA. The agency issued two medication fraud alerts where it said it had found undisclosed piroxicam, a non-steroidal anti-inflammatory drug (NSAID), in the products, which may increase the risk of cardiovascular complications and cause serious gastrointestinal damage. It also warned about potential drug-drug interactions that may increase the risk for other adverse events.

Liang Zhao, director of the Division of Quantitative Methods and Modeling in the Office of Generic Drugs (OGD), and Mehul Mehta, director of the Division of Neuropsychiatric Pharmacology in the Office of Translational Sciences (OTS), took part in an FDA Q&A where they spoke about how the agency oversees narrow therapeutic index (NTI) drugs. They discussed how the Center for Drug Evaluation and Research (CDER) determines what drugs qualify as NTI, how they promote the development of NTI generic drugs, and how they work to harmonize on the issue with other regulators.

In an interview with Reuters, FDA Commissioner Robert Califf said he is very concerned about the prevalence of fake and counterfeit versions of weight loss drugs, including Novo Nordisk's Wegovy (semaglutide) and Eli Lilly's Zepbound and Mounjaro (tirzepatide).

Medtech

On 29 February, FDA hosted its fourth virtual town hall on medical device sterilization as part of its efforts to help manufacturers ween off of ethylene oxide (ETO) for their sterilization needs, especially as the Environmental Protection Agency (EPA) is set to publish rules restricting use of the agent. During the town hall, the agency discussed when sponsors should submit a new premarket application and use device master files (MAF) when updating their sterilization processes. FDA told Focus sponsors could potentially use a predetermined change control plan (PCCP) to enable them to make future updates without submitting a new premarket application but should first talk to the agency using its pre-submission program.

According to the Office of Management and Budget (OMB) website, FDA has submitted a draft guidance to update its premarket cybersecurity guidance for review which is pending review. The guidance would require sponsors to submit information in their premarket applications under FDORA that ensures they meet certain cybersecurity requirements.

FDA cautioned health care providers and facilities on the safe use of electrical operating room tables after receiving adverse events reports associated with improper use. Some recommendations include ensuring instructions for use are properly followed, staff are adequately trained, and the tables are serviced periodically.

GE Healthcare subsidiary Wipro GE has initiated a class I recall of its Care Plus, Care Plus models 1000-4000 and Lullaby incubators according to FDA due to faulty door latches. The devices supply heated and humidified air to newborns who need help regulating their body temperature, and the faulty latches could lead to babies falling out of the incubators. The agency reports there has been one serious injury but no deaths.

FDA issued a safety communication to patients and healthcare providers that DT MedTech's Hintermann Series H3 Total Ankle Replacement (TAR) systems have a higher-than-expected risk of failure based on initial post-market data. The agency said it is still evaluating an interim post-approval study (PAS) of the devices but so far it has noticed that patients are prone to needing additional surgery when implanted with the devices and is working with the company to understand better why they have a higher-than-expected failure rate.

FDA announced it will host a virtual public workshop on 17 April so stakeholders can discuss how to expand the Accreditation Scheme for Conformity Assessment (ASCA) program. The program is meant to help streamline conformity assessments during premarket application reviews and currently only includes medical device standards and test methods that address basic safety, essential performance, and biocompatibility.

FDA published a safety communication to patients and healthcare providers about potential risks of serious complications associated with Hologic's BioZorb Marker and BioZorb LP Marker soft tissue implants used to mark future surgical sites radiographically. The agency said it has received adverse event reports where the devices have been implanted into breast tissue and led to infections, fluid buildup, broken through the skin, and caused other issues. It reminded users that the devices do not have market authorization for cosmetic use.

This Week at FDA: Government shutdown averted, FDA updates device standards, and more

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