This Week at FDA: Conflict of interest questions threaten to cloud Shuren’s legacy, FDA signs off on updated COVID vaccines

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 New York Times published an article scrutinizing potential instances of conflict of interest by FDA’s former device chief Jeff Shuren, FDA authorized updated COVID-19 vaccines ahead of the fall immunization campaign, and FDA issued its much-anticipated draft guidance on pre-determined change control plans (PCCPs).

According to the Times, Shuren, who headed FDA’s Center for Devices and Radiological Health (CDRH) for the last 15 years, may have skirted ethics rules by not recusing himself from situations involving companies represented by Arnold & Porter, where his wife, Allison Shuren, is a partner and co-chair of the firm’s life sciences and healthcare regulatory practice. The article notes several instances where Shuren had some level of involvement or did not recuse himself from the agency’s oversight of matters related to firms represented by Arnold & Porter. Without citing any specific cases, FDA confirmed to the Times that “it appears there were certain instances from about 10 years ago for which Dr. Shuren should have either recused himself or sought ethics authorization to participate to avoid any potential appearance of bias.” However, FDA told the newspaper that it has no indication that any agency decisions were impacted by Shuren’s wife’s employment.

Following the article, the consumer advocacy group Public Citizen asked the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) to investigate the allegations against Shuren.

Amid a recent surge in COVID-19 cases, FDA on Thursday approved updated versions of Pfizer and Moderna’s mRNA vaccines targeting the Omicron KP.2 strain for adults and children 12 and older. The agency also granted an emergency use authorization (EUA) amendment for each of the vaccines for use in individuals 6 months through 11 years of age.

FDA also issued its highly-anticipated draft guidance laying out what sponsors should know when filing premarket submissions that include pre-determined change control plans (PCCPs). The agency also scheduled a webinar on 3 September to outline its thinking on the guidance.

After publishing its final guidance earlier this month on drug interaction studies that conform to the International Council for Harmonisation (ICH) M12 guideline, FDA announced it would hold a 9 October webinar to provide an overview of the guidance. The agency noted that it is the first globally harmonized regulatory guidance on assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters.

FDA finalized a guidance on user manuals that manufacturers can include as part of their electronic product in either paper or electronic format. The agency noted that electronic media are now more widely used to provide more instructions to users that reduce the need for paper and allow for quick updates.

Drugs & Biologics

The Vaccines and Related Biological Products Advisory Committee is holding a partial public meeting on 20 September to discuss using pertussis Controlled Human Infection Models (CHIMs) in pivotal studies to evaluate pertussis vaccines, and to hear from representatives of the Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI) research program in the Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, at the Center for Biologics Evaluation and Research (CBER). However, after those sessions the committee will go into closed session to deliberate.

The Center for Biologics Evaluation and Research (CBER) announced the approval of several products, including the biologics licensing applications (BLA) for Adaptimmune's Tecelra (afamitresgene autoleucel) to treat certain patients with unresectable or metastatic synovial sarcoma who have already received chemotherapy, and Janssen Biotech's Lazcluze (Lazertinib) in combination with (Rybrevant) amivantamab-vmjw to treat locally advanced or metastatic non-small cell lung cancer (NSCLC). The center also approved supplemental BLAs for GlaxoSmithKline's meningitis vaccine Bexsero (meningococcal group B), and lower respiratory tract disease (LRTD) vaccine Arexvy (respiratory syncytial virus).

CBER has scheduled a webinar on 16 October to provide an overview of the end-to-end testing results for the Global Pharmaceutical Product Identification (PhPID) Service operating model, which generates global PhPIDs for marketed medicinal products. The center said it will update stakeholders on the model's deployment status.

Medtech

FDA updated a final guidance on how the agency responds to requests for information regarding how it classifies medical devices that now includes information on how it will accept such requests through its electronic Submission Template And Resource (eSTAR). The agency also finalized a guidance how to submit de novo requests in electronic format and a guidance that is a Small Entity Compliance Guide (SECG) for companies to comply with the Mammography Quality Standards Act (MQSA).

CBER approved Cerus' premarket approval application (PMA) supplement to update the labeling for its Intercept blood system for plasma to include updates for Factor XIII Antigen, ADAMTS13 Function, and C3a. The system is used to inactivate certain pathogens that may be found in plasma.

According to the FDA, ICU Medical has issued a class I recall updating its user instructions on appropriate battery management for its Plum 360, A+, and A+3 Infusion Systems. The company has received reports that the products have had issues with diminished battery life due to a manufacturing defect.

Inari Medical has also issued a class I recall updating its use instructions for its ClotTriever XL Catheter, which is used to remove clots and blockages from large blood vessels outside the heart. According to the FDA, the company has received reports of the devices becoming entrapped or blocking the lung arteries, which has resulted in four injuries and six deaths.

Defibtech issued a class I recall, stating that it is withdrawing certain Defibtech RMU-2000 ARM XR Chest Compression Devices after reports that the motor on the devices may malfunction, causing them to stop conducting compressions. The company has recorded one death due to the malfunction and said it will refund, replace, or replace the affected devices for free.

SoClean's SoClean 3+ Bacterial Reduction Device has been authorized by FDA as an over-the-counter device used to reduce microbial infections on compatible continuous positive airway pressure (CPAP) machines. The agency also approved BD's (Becton, Dickinson and Company) Onclarity HPV Assay, used with the BD Viper LT and BD COR Systems to detect the human papillomavirus (HPV).

This Week at FDA: Conflict of interest questions threaten to cloud Shuren’s legacy, FDA signs off on updated COVID vaccines

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