This Week at FDA: New approvals, upcoming meetings, 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, we saw FDA grant several notable approvals, including to the first orally administered fecal microbiota therapy and to a new drug to treat amyotrophic lateral sclerosis (ALS).

FDA announced several new drug approvals this week. On Thursday, the agency approved Pfizer’s next-generation pneumococcal vaccine, Reuters reports. Earlier in the week, the agency approved Seres Therapeutics’ VOWST, the first orally administered fecal microbiota product for the prevention the recurrence of Clostridioides difficile infection. It also granted accelerated approval to Biogen’s Qalsody (tofersen) to treat adults with ALS who have a mutation in the superoxide dismutase 1 (SOD1) gene.

Following recent updates to simplify the vaccination schedule for bivalent mRNA COVID-19 vaccines, FDA on Friday said it had authorized new uses of the Pfizer-BioNTech vaccine for immunocompromised children 6 months to 4 years of age. Now, children in that age group who have had three 0.2 ml doses of the vaccine (monovalent or bivalent) may receive a fourth dose of the bivalent vaccine at least 1 month following their last dose. FDA also said that it authorized “additional doses that may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances.”

The agency announced it will hold its annual Regulatory Education for Industry (REdI) conference from 5-9 June 2023. The directors of the agency’s three medical product centers will present at the five-day meeting.

In other news, FDA extended the comment period on its recent Data and Technology Strategic Plan by 30 days, giving interested parties until 12 June 2023 to comment. It also opened a new request for comments on the draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies for the electronic submission of PQ/CMC data, following previous solicitations in 2017 and 2022.

Politico reports that lawmakers on both sides of the aisle on the House Energy & Commerce health subcommittee expressed support for expanding Medicare coverage for Biogen and Eisai’s Alzheimer’s drug Leqembi (lecanemab-irmb), which was granted accelerated approval earlier this year. The Centers for Medicare and Medicaid Services (CMS) only covers the drug, and other monoclonal antibodies for Alzheimer’s, for patients who enroll in a randomized clinical trial. CNBC reports that Brooks-LaSure said her agency will cover Lequembi if FDA grants the drug full approval, though it would still require patients to enroll in federally approved registries.

According to Inside Health Policy, Republican lawmakers are proposing to cut $150 million of COVID-19 funding from FDA as part of their proposed debt ceiling package.

In other developments, the US Government Accountability Office (GAO) issued a report on the growing threat of antibiotic resistance. The report found that while federal agencies have taken steps to combat the threat of such resistance, more action is needed.

Drugs & biologics

Endpoints reports that Eli Lilly is planning to use a priority review voucher (PRV) to speed the review of its type 2 diabetes drug Mounjaro (tirzepatide) to treat obesity following a successful Phase III trial.

FDA’s Office of Prescription Drug Promotion (FDA) announced it will move forward with two studies related to prescription drug advertising. One of the studies involves a tradeoff analysis of drug claims in direct-to-consumer and healthcare provider promotion, while the other will look at endorser status and actual use in direct-to-consumer television ads. The agency sought comments on both studies in Federal Register notices last year.

FDA on Twitter announced it has signed an agreement with Korea’s Ministry of Food and Drug Safety (MFDS) to host a joint workshop for international regulators on artificial intelligence in medical product development.

The agency also announced it will hold a two-day public workshop on 7-8 June 2023 on its Rare Disease Endpoint Advancement pilot program.

FDA on Friday issued its final ICH S12 guidance on nonclinical biodistribution considerations for gene therapy products.

Additionally, the agency will host its annual FDA Science Forum virtually from 13-14 June 2023.

In other developments, FDA issued a warning letter to Pharmaplast S.A.E. in Alexandria, Egypt for “significant” GMP violations; including failing to test its API ethanol for the presence of diethylene glycol (DEF) or ethylene glycol (EG) drug, which are viewed as contaminants. FDA reminded the firm that “the use of glycerin contaminated with diethylene glycol (DEG) has resulted in various lethal; poisoning incidents in humans worldwide.” The firm was placed on an import alert.

FDA also found similar testing lapses in its warning letter to Voyant Beauty, a division of Accra-Pac, which makes over-the-counter (OTC) topical drug products. After inspecting the firm’s site in Elkhart, IN, inspectors said the firm failed to investigate products for benzene contamination. “After obtaining information, including data from your customer indicating that your finished products manufactured with isobutane propellants were contaminated with benzene, your propellant investigation was limited to isobutane propellants.” Additionally, the firm failed to screen incoming materials for the presence of DEG and EG.

The agency recently issued a Form 483 report to Alvotech in Reykjavik, Iceland following a March 2023 inspection; the firm is developing a biosimilar version of Humira. The agency listed eight observations, including lack of quality assurance and lack of supervisory oversight, inadequate root cause investigations, and inadequate controls over computer equipment. FDA also handed a 483 to the firm last year for different violations.

Medtech

FDA on Thursday warned that some Illumina sequencers are susceptible to a cybersecurity vulnerability that could pose risks to patients and customer networks. The vulnerability affects the devices’ Universal Copy Service (UCS) software and could enable an unauthorized user to take remote control of a device, alter its setting or impact genomic sequencing results, though the agency said that neither it nor Illumina have received any reports that the vulnerability has been exploited. Illumina has developed a patch to address the vulnerability and has notified affected customers of the issue.

Politico reports that the Environmental Protection Agency (EPA) butted heads with other federal agencies as it prepared its proposed rules placing restrictions on ethylene oxide (EtO), which is commonly used to sterilize medical devices. During the interagency review, some comments noted concerns that the policy could “inadvertently contribute to significant medical device supply chain disruptions.” Politico also reported that FDA Commissioner Robert Califf called on device makers at the MDMA Annual Meeting to “make your voice heard” on the proposed regulations and that he is “very worried” about the potential ramifications of the proposed rules.

This week, FDA issued a warning letter to London-based device manufacturer Medivance Instruments Ltd. following an August 2022 for making multiple changes to its Velopex Aquacut Fluid Abrasion Unit and accessories without seeking a new 510(k). These devices are used for a range of dental procedures, including sealant and cavity preparations. The firm received 510(k) clearance for the device in October 2003. Since it was cleared, however, FDA said that the device has been “in multiple ways, significantly changed or modified in design, components, method of manufacture, or intended use within meaning of 21 CFR 807.81(a)(3).”

This Week at FDA: New approvals, upcoming meetings, and more

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