This Week at FDA: CMS inflation rebates, FTC steps into Amneal patent dispute, and a new GAO report

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, the Biden Administration said it may lower coinsurance prices for certain Medicare drugs, the Federal Trade Commission (FTC) got involved in a patent dispute between drugmakers Teva and Amneal, and the Government Accountability Office (GAO) released a report on tracking implantable medical devices.

The Centers for Medicare and Medicaid Services announced that 41 drugs in the Medicare Part B program will have lower coinsurance between 1 April and 30 June if the price of the drugs increases faster than the rate of inflation. The lower coinsurance rate is part of President Joe Biden's efforts to lower drug prices under the Inflation Reduction Act (IRA).

After Amneal filed an application with FDA to get approval for a generic version of the asthma inhaler ProAir HFA, Teva filed a patent infringement case against the company. Now, FTC has entered the fray by filing an amicus brief siding with Amneal. The agency argues that Teva has improperly listed patents in the Orange Book and asked the court to order them to be removed.

A new GAO report found that the Veterans Health Administration (VHA) policies are ineffective in ensuring that implantable device recalls are relayed to patients and their providers. The agency recommended that the VHA should adopt a policy that non-biological orthopedic devices are effectively tracked and assess their ability to do so to find any gaps.

FDA announced the launch of its Center for Drug Evaluation and Research’s new Quantitative Medicine (QM) Center of Excellence (CoE) to promote the use of quantitative medicine in drug development. The agency also announced it will host a virtual public workshop on 25 April to discuss the topic and the center's purpose.

Consumers were warned by FDA not to use certain over-the-counter (OTC) analgesics that may contain lidocaine and that have been marketed as topical pain relief for those who undergo certain cosmetic procedures, including microdermabrasion, laser hair removal, tattooing, and piercing. The agency noted that it has sent warning letters to six companies for selling such products without marketing authorization.

FDA reminded the public that it regulates OTC and prescription allergy medication, and allergen extracts that may be used to diagnose and treat allergies. Besides explaining how allergies may affect children, the agency also told the public to pay attention to the labeling on allergy drugs.

The Reagan-Udall Foundation, FDA, and the National Institutes of Health (NIH) announced they would co-host a meeting on 13 May, bringing together rare disease patient advocates, researchers, and industry to discuss using natural history studies and registry data to develop drugs for rare diseases. The meeting will include discussions about the role and design of registries and natural history studies and what to consider when collecting data from such studies that can be used for regulatory decisions.

Drugs & Biologics

FDA published its over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC Monograph Drug User Fee Program (OMUFA) for FY 2024. Between 1 October 2023 and 30 September 2024 the fee for MDF facilities is set at $34,166 and $22,777 for contract manufacturing organization (CMO) facilities.

The Center for Drug Evaluation and Research (CDER) published two manuals of policies and procedures related to how it will address risk evaluation and mitigation strategy (REMS). The first manual describes how regulators will review REMS methodological approaches proposed by manufacturers. The second manual describes how they plan to review REMS assessment reports and address situations where reports have not been submitted on time or are missing key information.

The Center for Biologics Evaluation and Research (CBER) said it now supports the use of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Implementation Guide—Animal Rule Version 1.0 (SENDING–AR v1.0). Starting on 15 March 2027, sponsors will be required to adhere to the standard in their electronic premarket submissions, and FDA will update its Data Standards Catalog with the standard.

FDA announced it will host a virtual workshop to discuss statistical considerations when assessing risk in premarket applications. More specifically, the presenters will talk about important statistical considerations when assessing drug safety, how to plan for drug safety assessments, and how to analyze the drug safety data.

The Office of Generic Drugs (OGD) also announced it is hosting a virtual meeting on 9 May to discuss how pre-Abbreviated New Drug Application (ANDA) meetings are handled by FDA under the Generic Drug User Fee Amendments (GDUFA III) agreement. Presenters will discuss how redesigning pre-ANDA meetings may benefit sponsors, discuss hypothetical scenarios, and allow sponsors to ask regulators about the meetings.

Qin Sun and Sarah Ridge in the Office of Clinical Pharmacology at CDER sat down for a podcast to discuss the recently finalized guidance on addressing clinical pharmacology issues when developing antibody-drug conjugates (ADC). The guidance authors touched on several document areas, including defining ADCs, major considerations for ADC dosing strategies, and evaluating drug-drug interactions.

Medtech

The Center for Devices and Radiological Health (CDRH) announced its electronic Submission Template And Resource (eSTAR) is now available for 513(g) requests. The 513(g) request process allows manufacturers to ask the agency about a specific device's classification and regulatory requirements.

The Mammography Quality Standards Act and Program section on FDA's website was updated to "enhance user experience and provide the most up-to-date information, including reordering and renaming the landing pages so the information is easier to find," according to the agency. It also said it has deleted old information on the site that is no longer current.

The Medical Device Innovation Consortium (MDIC) and FDA are co-hosting a two-day public meeting starting on 16 April to discuss computational modeling and simulations. The meeting will include presentations on assessing model credibility, applying computational evidence, and present real-world case studies.

Medline has issued a class I recall of certain convenience kits, trays, and packs that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP made by Nurse Assist. The recall follows a recall by Nurse Assist of its saline solutions in November after sterility concerns were raised that could lead to serious infections and potentially death.

Medline's Autologous Regeneration of Tissue (ART) Skin Harvesting System was given marketing authorization by FDA as the first-of-its-kind handheld, semi-automated device to take healthy skin tissue from patients so they can be grafted onto wounds on other parts of the patient. The agency said that the device uses thin needles to collect micrograft samples instead of thin sheets of skin with a blade, which means it's minimally invasive and requires local anesthesia.

This Week at FDA: CMS inflation rebates, FTC steps into Amneal patent dispute, and a new GAO report

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