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26 September 20237 minute read

FDA Regulatory News and Trends - September 26, 2023

Welcome to FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal, and regulatory world.

Update to enforcement policy for face masks.

  • On September 5, 2023, FDA released a new version of its Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, the latest version of which was published in March 2023.  

  • The new version includes two updates.  First, the policy is now entitled, “Enforcement Policy for Face Masks and Barrier Face Coverings for the Coronavirus Disease (COVID-19) Response.”  Second, the policy has been revised to align with the duration of the relevant declaration supporting authorization of emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  

  • This enforcement policy was originally part of the guidance, “Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised),” but, in March 2023, FDA split that guidance into two separate policies: one covering face shields, surgical masks, and respirators, and the other covering face masks and barrier face coverings.  While the former enforcement policy expires 180 days after the expiration of the public health emergency, the latter will remain in effect for the duration of the declaration under section 564 of the FD&C Act.  

Draft guidance on meetings with FDA after generic drug manufacturing facilities receive warning letters.

  • On September 5, 2023, FDA announced a new draft guidance, “Post-Warning Letter Meetings Under GDUFA,” which provides information on the post-warning letter meeting process for certain drug manufacturing facilities, a program implemented by the Generic Drug User Fee Amendments (GDUFA) for fiscal years 2023–2027.  

  • The draft guidance describes the factors relevant to determining whether a facility is eligible to request a meeting with FDA and the process for how an eligible facility may request a meeting after receiving a warning letter to discuss the facility’s ongoing current good manufacturing practice (cGMP) remediation efforts.  The guidance also includes information about how to prepare and submit a meeting package, and how FDA plans to conduct these meetings with facilities.  

  • The purpose of these post-warning letter meetings is to obtain feedback from the FDA on the adequacy and completeness of corrective and preventive action (CAPA) plans to resolve the inspectional deficiencies identified in the warning letter.  Discussions related to pending or planned applications are not considered appropriate topics.  

  • Comments on the draft guidance should be submitted by October 5, 2023.

CDER, CBER, and OCE release guidance related to real-world evidence.

  • On August 30, 2023, CDER, CBER, and Oncology Center of Excellence (OCE) released a draft guidance document titled, “Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products.”

  • In this guidance, FDA makes several recommendations for designing a real-world evidence (RWE) study. For example, the Agency suggests that companies should outline other data sources they considered and explain why those sources were not selected. Companies should also ensure patient-level data is available for FDA review for marketing applications subject to 21 CFR 314.50 and 601.2. Further, the guidance makes clear that RWE studies examining the use of a drug in routine medical practice must comply with postmarketing safety reporting regulations (ie, adverse event reporting).

  • Companies planning an RWE study should incorporate the recommendations in this guidance into their study design, and are encouraged to engage with FDA early to discuss adequacy of study plans.

FDA issues two compliance policy guidances on DSCSA.

  • FDA issued two Drug Supply Chain Security Act (DSCSA) compliance policy guidances: “Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the FDCA,” dated August 25, 2023, and “Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product,” dated August 30, 2023.

  • The first guidance describes FDA’s compliance policies regarding enforcement of requirements for the interoperable, electronic, package-level product tracing (referred to as “enhanced drug distribution security requirements”) under the FD&C Act that will go into effect on November 27, 2023. The Agency stated that it does not intend to take action to enforce certain requirements until November 27, 2024, including the mandate for exchanging package-level transaction information (standardized numerical identifier consisting of the NDC and serial number, lot number, and expiration date) and requirements for prompt response to information requests.

  • The second guidance document is a revised version of FDA’s 2020 Compliance Policies guidance, dated October 23, 2020, which required wholesale distributors to verify the product identifier prior to further distributing saleable returned product and requiring dispensers to verify the product identifier for suspect or illegitimate product in the dispenser’s possession or control. The revised guidance revises and extends the targeted compliance date from November 27, 2023 to November 27, 2024.

FDA issues two final guidances on DSCSA.

  • In addition to the two compliance policy guidances, FDA also issued two final guidances on DSCSA compliance: “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act,” dated August 30, 2023, and “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs,” dated September 5, 2023.

  • The first guidance clarifies the enhanced drug distribution security requirements and provides recommendations with respect to the system attributes necessary to enable secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary. Requirements for enhanced drug distribution security, commonly referred to as the “enhanced system,” go into effect on November 27, 2023. 

  • One second guidance document identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies who and what are subject to such standards. This guidance finalizes the policies to reflect the enhanced drug distribution security requirements (FD&C Act § 582; 21 U.S.C. 360eee-1) that will go into effect on November 27, 2023, including that only electronic methods of product tracing will be permitted and verification of product at the package level will be required, with certain exceptions.

James “Jim” Jones to serve the first Deputy Commissioner for Human Foods.

  • On August 24, 2023, FDA announced that James “Jim” Jones will serve as the first Deputy Commissioner for Human Foods. Jones will lead the charge in setting and advancing priorities for a proposed unified Human Foods Program (HFP).

  • Program areas would include food safety, chemical safety, and innovative food products, including those from new agricultural technologies, that will bolster the resilience of the US food supply in the face of climate change and globalization, as well as nutrition to help reduce diet-related diseases and improve health equity.

  • Jones’s tenure at FDA will commence on September 24, 2023.