This Week at FDA: Updated guidance on denying inspections and biosimilar interchangeability

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 expanded its guidance on delaying or denying inspections to include medical devices, the agency finalized a rule regulating medical gases, and it updated its guidance on demonstrating biosimilar interchangeability.

The agency published a final guidance on what it defines as behavior by a manufacturing facility to delay, deny, or limit inspection, or refuse entry or inspection. A previous version of the guidance only addressed drugs, but the newest version also applies to device manufacturers as mandated under the 2017 FDA Reauthorization Act (FDARA).

FDA finalized a rule that revised its current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling requirements for certain medical gases as mandated under the 2017 Consolidated Appropriations Act (CAA). The rule established regulatory requirements for getting certification for medical gases.

According to STAT News, several House Republican lawmakers have written to FDA taking issue with its collaboration with the Coalition for Health AI (CHAI), arguing that the “assurance lab model you are supporting by partnering with CHAI would effectively put large organizations that are actively developing and commercializing AI models of their own in the position of evaluating AI programs developed by affiliated companies or competitors.”

STAT News also reports that the former CEO of medical device maker Stimwave, Laura Perryman, has been sentenced to 6 years in prison for her role in a scheme to sell its nerve stimulation devices with spurious plastic parts that would fetch greater reimbursement from insurers and enable the company to charge more for the devices.

Reuters reports that Eli Lilly is continuing to sue companies, such as medical spas, that offer compounded versions of its weight-loss drug Mounjaro (tirzepatide), claiming that the firms advertised the drugs as being FDA approved.

Last week, FDA sent a warning letter to retailer Dollar Tree, chastising the company for failing to adequately remove recalled fruit puree pouches with elevated levels of lead.

The agency also published a Form 483 it handed to Dr. Reddy’s Laboratories concerning the company’s facility in Andhra Pradesh, India following an inspection in May and June 2024. Among the observations, FDA investigators cited the firm for not having adequately validated or verified in-house and compendial test methods for commercial active pharmaceutical ingredients (APIs) and failing to thoroughly review unexplained discrepancies after batch testing failures.

FDA announced an upcoming webinar on 23 July 2024 to provide an overview of its Office of Trade and Global Partnerships.

Drugs & Biologics

FDA will host a hybrid public workshop on 22 July to discuss best practices for meeting management as part of its agreement with the drug industry under the Prescription Drug User Fee Act (PDUFA VII) deal. The agency said it has contracted Eastern Research Group to do an assessment of how regulators conduct meetings with sponsors, the results of which will be presented at the meeting.

This week, FDA released an updated version of its draft guidance on demonstrating biosimilar interchangeability. “The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim director of the Office of Therapeutic Biologics and Biosimilars.

The guidance was first issued in 2019, and FDA said the updated version reflects the experience gained in the nearly 10 years since the first biosimilar was approved in the US, which has shown that biosimilars are typically safe and effective, even when switching between versions multiple times. As such, FDA has revised its approach to when switching studies will generally not be needed.

Alongside the draft guidance, FDA also published a blog post explaining biosimilars and interchangeable biosimilars. In the post, the agency said that by updating the guidance and possibly requiring fewer studies, it aims to create a framework that will allow interchangeable biosimilars to come to market faster while ensuring the same level of safety and effectiveness.

Industry organizations interested in participating in the Center for Drug Evaluation and Research’s (CDER) advisory committees are asked to contact FDA. The agency is looking for industry representatives to advise as nonvoting members on seven advisory committees, including committees on anesthetic and analgesic drugs, cardiovascular and renal drugs, and gastrointestinal drugs.

On Thursday, FDA expanded the accelerated approval of Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec-rokl) to treat ambulatory and non-ambulatory children ages 4 and older with a confirmed mutation in the DMD gene.

On Monday, FDA approved Merck’s Keytruda (pembrolizumab) with carboplatin and paclitaxel following single-agent treatment with pembrolizumab in adults with primary advanced or recurrent endometrial carcinoma. The application was granted priority review and used the agency’s Assessment Aid, as well as undergoing a joint review under Project Orbis that included Australia’s Therapeutic Goods Administration, Brazil’s Health Regulatory Agency, Health Canada, and Israels’ Ministry of Health.

The American Society of Addiction Medicine (ASAM) has released a draft version of its Clinical Practice Guideline on Benzodiazepine Tapering for comment. The guideline recommends that patients who have been taking benzodiazepine for more than a month should gradually taper their dosage under clinical supervision. The development of the guideline is funded by FDA.

Medtech

Troy Tazbaz, director of the Digital Health Center of Excellence (DHCoE) at the Center for Devices and Radiological Health (CDRH), wrote a blog post on aligning stakeholders, including regulators, providers, and the medical industry, on how to use artificial intelligence (AI) in health care most effectively. They include developing standards, best practices, and risk management frameworks.

CDRH announced it has contracted with the architectural firm HKS to help develop its Home as a Health Care Hub project, which aims to create an integrated healthcare environment in the home. The agency expects the project's virtual reality prototypes to be ready by the end of 2024.

FDA will host a virtual public meeting on 25 July to discuss its Home as a Health Care Hub project. The meeting will allow the agency to get stakeholder feedback on what to consider when developing the prototypes.

FDA gave an update on its efforts to remove Chinese-made faulty plastic syringes from the US market. This week, the agency said Cardinal Health is the latest company to issue a recall for its Merit Medical kits containing Jiangsu Shenli Medical syringes made in China.

FDA is seeking input on non-device software functions and their impact on patient safety. Such software functions include administrative support of health care facilities, healthy lifestyle apps, electronic patient records, and software that provides “limited clinical decision support.” The public docket can be found here.

This Week at FDA: Updated guidance on denying inspections and biosimilar interchangeability

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