This Week at FDA: Countdown to government shutdown, FDA warns about data integrity and wearables

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 eyes are back on Congress as government shutdown deadlines approach, FDA created a digital health advisory committee, and published several guidances.

With only a week to go before a potential government shutdown, there's still a lot of uncertainty on whether lawmakers can negotiate an agriculture/ FDA appropriations bill by 1 March. As Steve Grossman at the Alliance for a Stronger FDA points out, there are significant disagreements over a legislative rider that restricts the US Food and Drug Administration’s (FDA) authority to allow the abortion drug mifepristone on the market. The disagreements and lack of time to negotiate them could lead to another short-term continuing resolution.

FDA announced it is establishing a Digital Health Advisory Committee, which will consist of nine external members, including a chairperson, who will advise the agency on digital health technologies (DHT). When asked, it will provide input on issues such as artificial intelligence/machine learning (AI/ML), augmented reality (AR), virtual reality (VR), digital therapeutics, wearables, remote patient monitoring, software and more.

FDA warned medtech sponsors and manufacturers to double-check the work of third-party testing laboratories before their data is submitted in premarket submissions. The agency is concerned that some labs are faking data and singled out entities from China and India.

Patients and healthcare providers were also warned by FDA against over-relying on wearables such as smartwatches and smart rings that don't pierce the skin to measure blood glucose levels. The agency emphasized such smart devices are not like continuous glucose monitors (CGM) that pierce the skin to read blood glucose levels and have been authorized on the market for that purpose.

FDA published a couple of guidances this week, including a draft guidance on how small businesses can qualify for reduced fees under the Medical Device User Fee Amendments (MDUFA V) deal. The agency notes that under the new deal, it has the discretion to waive annual registration fees for small establishments that face financial hardship if forced to pay the fee, and the guidance details the agency's thinking.

FDA finalized a guidance entitled, “Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.” The guidance details what sponsors should consider when measuring and analyzing common COVID-19-related symptoms in clinical trials when developing drugs and biologics.

The Association for Accessible Medicines (AAM) commented on an FDA draft guidance on the translation of good laboratory practice study reports, which had a comment period ending on 20 February. AAM says it anticipates sponsors will likely use AI to translate study reports in the future and the agency should take that into account in the final guidance.

In a letter to FDA Staff, Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER), announced that Sridhar (Sri) Mantha has been made permanent director of the Office of Strategic Programs (OSP). Mantha, who previously worked at Novartis, Alcon, AstraZeneca and MedImmune, is also director of the Office of Business Informatics (OBI) and will act as acting director until a replacement is found.

Hyman, Phelps & McNamara announced Ana Loloei Marsal, a 14-year veteran of FDA who most recently served as senior regulatory counsel in the Office of Policy at CDRH, has joined the law firm. It notes that while she has a wide range of regulatory knowledge, she her expertise is in product marketing, labeling, promotion, and advertising.

FDA published a Q&A interview with June Raine, CEO of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), about how it has transitioned from its oversight under the European Medicines Agency (EMA) due to Brexit and the importance of partnering across the pond. One area she singled out is MHRA's collaboration with FDA in developing regulations around artificial intelligence/ machine learning (AI/ML).

While Russia's invasion of Ukraine continues, STAT reports that Ukrainian researchers and executives are urging companies to restart clinical trials in the country. They argue that trials can be conducted away from the war zone where researchers and participants can continue to live with some normalcy.

Drugs & Biologics

The Office of Generic Drugs published its annual report, which states last year the agency approved or tentatively approved 956 Abbreviated New Drug Applications (ANDAs), issued 1,493 complete response letters (CRL), and spent $20M funding generic drug science and research projects. Among its achievements, it noted it had approved Alkermes' Vivitrol, the first generic naltrexone extended-release injectable suspension used to treat alcohol dependence and prevent opioid addiction relapse.

The Center for Biologics Evaluation and Research (CBER) published its standard operating policy and procedure (SOPP) for staff on how to address postmarketing requirements (PMR) and postmarketing commitments (PMC). It details procedures CBER staff are expected to follow with sponsors about their PMRs and PMCs before they are implemented.

Sichuan Deebio Pharmaceutical received a warning letter from FDA for violating current good manufacturing pratices (CGMP) at its Sichuan, China, manufacturing plant. The agency cited it for failing to document laboratory controls and explain departures from laboratory procedures properly, and docked its quality unit for failing to meet their responsibilities.

Reuters reported that United Therapeutics has filed a case with FDA against Liquidia for submitting a premarket application for its blood pressure drug YUTREPIA (treprostinil). The company argues that FDA did not follow its own rules and procedures when accepting the drug application to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Reuters also reported that its analysis shows the price of new drugs in the US rose 35% last year compared to a year before. More specifically, it states that based on an analysis of 47 new drugs, the annual list price in 2023 was $300,000, compared to $222,000 in 2022.

Medtech

FDA said Medtronic has published a customer letter regarding its NIM CONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube, which were recalled in 2022 due to the risk of airway obstruction. The letter includes updated instructions for use (IFU), new training material, and Unique Device Identifier (UDI) information that is meant to help healthcare providers in operating rooms if the use of the devices leads to airway obstruction.

STAT reported that AI entrepreneurs and investors are being careful to document all their work and slow their progress because they're afraid of being audited in the future due to regulatory uncertainty. They are consulting with regulatory experts and growing their government outreach operations to ensure they're prepared for regulations that may affect their business.

This Week at FDA: Countdown to government shutdown, FDA warns about data integrity and wearables

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