This Week at FDA: Year-end guidance drop, counterfeit Ozempic, 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 issued a slew of end-of-year guidances, announced seizure of counterfeits of a popular weight-loss drug, and several drugmakers have asked for some of their patents to be delisted from the Orange Book.

As the year wraps up, FDA went on a guidance spree, publishing several guidances that fulfill legislative requirements under the 2022 Food and Drug Omnibus Reform Act (FDORA) and address the use of real-world evidence.

FDA finalized guidance on how medical product sponsors can use digital health technologies (DHT) for remote monitoring patients in clinical trials. The agency said it has gained more experience with DHTs during the COVID-19 pandemic and that their use can help streamline trials as well as improve trial participation.

It also finalized guidance on developing drugs and biologics for rare diseases. The guidance outlines the agency's thinking on how to conduct efficient trials for products intended to treat rare diseases.

FDA updated and issued a final guidance on developing monoclonal antibody treatments for SARS-CoV-2 for emergency use authorization (EUA). The guidance updates the agency's thinking on how to address emerging variants of the virus.

FDA's Office of the Chief Scientist launched a new website where it will maintain a list of new topics for guidance generation or topics requiring revision to existing guidances. The agency also opened a docket where stakeholders can comment on the guidance topics presented.

FDA and the European Medicines Agency (EMA) published a joint question-and-answer document that details commonly accepted quality and good manufacturing practices (GMP), addressing FDA's Breakthrough Therapy and EMA's Priority Medicines (PRIME) programs. Since 2018, the agencies have shared their regulatory experiences and expectations with each other, which has led to the development of the document.

FDA and Novo Nordisk, the manufacturer of the diabetes drug Ozempic (semaglutide), are testing thousands of seized counterfeit versions of the drug. The agency again warned the public not to buy or use the counterfeit drugs that are often used for weight loss and to check their drugs for signs of counterfeiting. So far, FDA says it is aware of five adverse events from the lot it has seized.

FDA issued an update on how it plans to conduct in-person and virtual meetings on IT platforms with industry per its agreement under the Prescription Drug User Fee Amendment (PDUFA VII) and the Biosimilar User Fee Amendment (BsUFA III). While the Over-The-Counter Monograph Drug User Fee Act (OMUFA) did not include any such provision, the agency said it plans to conduct face-to-face meetings similarly for that program.

Endpoints News reported that GSK, Amneal Pharmaceuticals and Kaléo have asked for certain patents to be pulled from FDA's Orange Book after the Federal Trade Commission (FTC) argued that more than 100 patents were wrongfully on the list. Officially known as the Approved Drug Products with Therapeutic Equivalence Evaluations list, the Orange Book includes a list of FDA's approved drugs, including their patent and exclusivity information.

Drugs & Biologics

AstraZeneca on Thursday announced that FDA approved its drug Wainua (eplontersen) to treat polyneuropathy of hereditary transthyretin-mediated amyloidosis, a rare nerve disease. The drug, which was developed with Ionis, is the only approved treatment for the disease that can be self-administered via an auto-injector, said the company.

FDA has published an updated list of off-patent prescription and OTC drug without an approved generic. The list is updated every six months in June and December. This action is designed to “improve transparency and encourage the development and submission of ANDAs in markets with little competition,” said FDA.

In other news, Moderna asserted that FDA’s findings of manufacturing deficiencies at its Norwood, MA facility don't reflect quality and safety concerns, according to Endpoints, which obtained a Form 483 handed to the facility through a Freedom of Information Act request. A September inspection of the plant, which is used to manufacture its COVID-19 vaccine, listed five observations, including inadequate cleaning of equipment before usage. The company maintains the inspection isn’t cause for concern over quality and safety.

Chiesi announced that FDA has approved its topical gel for the treatment of epidermolysis bullosa, a rare skin disease. The company said the drug is the first approved treatment for wounds associated with junctional epidermolysis bullosa (JEB), a rare, moderate-to-severe form of EB with blisters beginning in infancy.

FDA announced a meeting of its Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs on 18 January 2024. The meeting follows-up on the launch of an agency pilot offering meeting opportunities to prospective generic drug applicants who intend to use MIE approaches for establishing bioequivalence (BE) establishment in their ANDAs.

Medtech

Earlier this month, FDA warned Fresenius Medical Care, citing the firm for four violations stemming from an inspection of its Waltham, MA facility between June and August 2023. The violations include failing to establish and maintain procedures for implementing corrective and preventive actions (CAPA), failing to document CAPA activities and their results, failing to maintain device design validation procedures and for not reporting a correction or removal of a device to reduce a health risk was not reported to the agency within 10 working days.

MedtechDive reports that FDA has approved the AutoGenomics’ AvertD as the first test to assess individual risk for developing opioid use disorder based on a DNA sample, despite an 11-2 vote against the test by the agency’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee in October 2022. Center for Devices and Radiological Health (CDRH) Director Jeff Shuren said the agency “worked with AutoGenomics” as the company modified its test. While the company originally sought a De Novo classification for the test, it eventually submitted the test through the premarket approval application (PMA) pathway.

FDA announced three Class I recalls of medical devices this week. The recalls include Medtronic Navigation’s StealthStation S8 Application Version 2.0 and 2.0.1 due to a software issue; Philips’ Panorama 1.0T HFO over the risk of explosion due to excessive pressure buildup of helium gas; and Olympus’ Bronchofiberscopes and Bronchovideoscopes due to a risk of burns and fire.

CDRH announced this week that it has now enrolled 25 medical devices in its Total Product Life Cycle Advisory Program (TAP).

This Week at FDA: Year-end guidance drop, counterfeit Ozempic, and more

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