This Week at FDA: VRBPAC to weigh COVID vaccine updates; a new gene therapy 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 announced an upcoming meeting to consider whether the composition of primary COVID-19 vaccine doses should be updated given waning immunity and continued evolution of the virus. We also saw the approval of the first gene therapy to treat bladder cancer, new guidance on what constitutes refusing or denying an inspection and the first labeling update for a chemotherapy drug to come from FDA’s Project Renewal.
 
In a major announcement, FDA on Friday said it will host a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) next month to consider updating the composition of primary doses of COVID-19 vaccines and whether the composition and schedule of boosters should be revised. The announcement follows the European Medicines Agency’s Emergency Task Force recommendation that adapted mRNA bivalent vaccines containing Omicron BA.4/5 from should be used for primary vaccination instead of earlier vaccines targeting the original SARS-CoV-2 strain.
 
The agency also announced the approval of Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy to treat patients with bladder cancer. The adenoviral vector-based gene therapy is specifically indicated to treat adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks said the approval “addresses an area of critical need.” The therapy received priority review, breakthrough therapy designation and fast track designations.
 
FDA this week issued a revised guidance that will, when finalized, supersede its 2014 final guidance on the circumstances that constitute delaying, denying, limiting or refusing an inspection. We’ll have more coverage of the guidance in Focus next week.
 
Politico reports that dietary supplement reform will not be included in an omnibus spending package, according to Senate Majority Whip Dick Durbin (D-IL), though he did not discuss other abandoned FDA riders, like diagnostics or cosmetics reform.
 
We also learned from Politico that drugmaker AbbVie is leaving two key industry lobby groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) next year amid fallout from the drug pricing provisions in the Inflation Reduction Act. BIO also recently parted ways with its former CEO, Michelle McMurry-Health.
 
The Department of Health and Human Services Office of Inspector General (OIG) has once again listed enhancements to FDA’s risk evaluation and mitigation strategies (REMS) for opioids as one of its top 25 unimplemented recommendations of the year. The recommendation was included in last year’s report, and the OIG notes that “FDA is in the process of updating two relevant REMS Manuals of Policies and Procedures and Guidance. FDA has also undertaken a number of activities and is planning additional activities related to opioid prescriber education. However, OIG still encourages FDA, in re-examining the feasibility of mandatory training, to revisit requiring manufacturers to conduct more aggressive outreach or partnering with State medical license boards.”
 
After criticism of political interference in the handling of the COVID-19 pandemic by key governmental agencies, the Government Accountability Office has published a report on how they can shield themselves from future interference. GAO says agencies should consider factors such as the number of political appointees, availability of advisory committees, and fixed terms for agency officials.
 
Drugs & Biologics
 
Four years after announcing an effort to update the labels of older chemotherapy drugs to ensure their labeling remains relevant, FDA on Thursday announced the first labeling update to stem from its Project Renewal pilot program. The label for Genentech’s Xeloda (capecitabine tablets) has been updated with eight new and revised indications, as well as six other labeling revisions. The new and revised indications include the drug’s use as an adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen and treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. Other labeling revisions include the removal of severe renal impairment as a contraindication, updated dosage information and updated clinical pharmacology information.
  
FDA has updated its generic drugs activities report for the first time in FY 2023, offering figures for October 2022. The agency has combined its monthly and quarterly reporting pages and says it will continue to update the report once a month. Some new metrics appear in the report based on requirements under GDUFA III.
 
The agency also released its semi-annual lists of off-patent, off-exclusivity drugs without approved generic competition. The lists detail hundreds of prescription and dozens of over-the-counter (OTC) products that lack generic competition. The previous versions of the lists were issued in June 2022.
 
FDA’s Office of Generic Drugs has updated its manual of policies and procedures on prioritizing the review of abbreviated new drug applications (ANDAs), ANDA amendments and ANDA supplements to reflect its GDUFA III commitments.
 
FDA has also published a draft guidance on antibiotics used in animals that may affect antimicrobial resistance in people. In recent years, there’s been growing concern that the overuse of antibiotics in animals used for human consumption may be contributing to an increase in drug-resistant bacteria. The guidance proposes using a qualitative risk assessment methodology to evaluate foodborne antimicrobial resistance.
 
Medtech
 
This week the FDA announced it was removing medical gloves from its device shortage list. At the start of the COVID-19 pandemic, the agency noted a number of personal protective equipment (PPE) were in short supply, which could have dire consequences for the healthcare system. As manufacturers have restarted production and gotten over global supply chain issues, several products have come off the device shortage list.
 
There have been serious concerns about the efficacy of over-the-counter pulse oximeters for patients with darker skin tones in the past few years. FDA recently held a public meeting on the topic, and now STAT reports that the agency has asked the Hypoxia Lab at the University of California, San Francisco to find ways to improve the effectiveness of the devices.