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26 May 20239 minute read

FDA Regulatory News and Trends - May 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.

Updated FAQ on medical device shortages to reflect the end of the COVID-19 public health emergency.

  • On May 12, 2023, FDA/CDRH updated its Supply and Shortages of Medical Devices: Frequently Asked Questions to address changes to requirements created during the COVID-19 pandemic, now that the public health emergency (PHE) has ended.

  • During the pandemic, CDRH implemented several policy changes to help navigate medical device shortages – for example, the acceptance of Emergency Use Authorizations for COVID-19-related products.

  • The recent update to the shortages FAQ revises several existing answers to reflect that the PHE and related policy changes have ended. It also adds three new questions and answers related to 506J notifications – for example, the requirement for manufacturers to notify FDA of disruptions in device supply).

SCOTUS declines to take up skinny label generic drug case.

  • On May 15, 2023, the US Supreme Court declined to hear a patent dispute case between Teva Pharmaceuticals and GlaxoSmithKline (GSK) over Teva's generic version of GSK's heart failure drug Coreg.

  • Teva was appealing the lower court's decision that found that the skinny label on Teva's generic drug, combined with marketing materials, induced infringement of GSK's patent. Skinny labels allow generic drug makers to seek approval for only the unpatented uses of the drug, therefore avoiding infringement issues.

New artificial intelligence and machine learning discussion papers.

  • FDA has released two discussion papers: one concerning the use of artificial intelligence (AI) in drug manufacturing and, more recently, one concerning the use of AI and machine learning (ML) in the development of drug and biological products.

  • These papers raise regulatory questions for consideration related to these areas of application of AI technology and call for feedback, with the aim of garnering engagement and collaboration from all interested stakeholders. 

  • See our client alert for more information on the discussion paper related to AI in drug manufacturing, released in March 2023.

  • The paper discussing AI/ML in drug development, released in May 2023, includes an overview of the current and potential uses of the technology in therapeutic development, and discusses the possible concerns and risks associated with these innovations and ways to address them. In addition, the paper poses a series of questions for feedback. The comment period ends on August 9, 2023.

  • FDA will host a workshop on the regulatory framework for the utilization of AI in pharmaceutical manufacturing, to be held September 26–27, 2023. Additionally, the Agency is planning a workshop to discuss how the community can work together to realize the potential of AI/ML for product development while being mindful of potential challenges.

Final guidance on animal drug shortages.

  • On May 12, 2023, FDA issued final guidance, titled, “Reporting and Mitigating Animal Drug Shortages.” The guidance replaced the May 2020 version, originally titled, “Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency,” and applies to the voluntary reporting of information related to all animal drug shortages, regardless of the drug’s status as a medically necessary veterinary product (MNVP).

  • Animal drug sponsors are encouraged to analyze shortage situations related to their specific products and inform the Agency once they become aware of a potential or actual animal drug shortage. The notice should include the root cause of shortage, timing of shortage, planning resolution, and any other information that may be relevant.

  • An approved supplemental application is required if the sponsor needs to utilize an alternate manufacturer or a new manufacturing facility for their drug product. Recent foreign regulatory good manufacturing practices (GMP) inspection reports can be submitted to facilitate the review. 

Final guidance on Quality Risk Management.

  • On May 4, 2023, FDA announced the availability of the final guidance document, “Q9(R1) Quality Risk Management,” prepared by the International Council for Harmonisation (ICH).  The guidance previously reached Step 4 of the ICH process on January 18, 2023, meaning it was open for adoption by individual regulatory authorities for application in their jurisdictions.  

  • The guidance is a revision of the 2006 guidance for industry, “Q9 Quality Risk Management,” and outlines the quality risk management process, risk management methodology, and integration of quality risk management into industry and regulatory operations, including the role of quality risk management in addressing product availability risks arising from quality/manufacturing issues. 

  • The guidance includes a new section, 5.3, on managing and minimizing subjectivity.  It states, “While subjectivity cannot be completely eliminated from quality risk management activities, it may be controlled by addressing bias and assumptions, the proper use of quality risk management tools and maximizing the use of relevant data and sources of knowledge.”

Marketing authorization for the first SARS-CoV-2 serology tests.  

  • On May 5, 2023, FDA granted two de novo applications for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, both manufactured by Ortho-Clinical Diagnostics, Inc.

  • Both tests are intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma samples collected on or after 15 days post-symptom onset as an aid in identifying individuals who have an adaptive immune response to SARS-CoV-2 from either a recent or prior infection.  Both tests are prescription use only.  

  • These are FDA’s first fully authorized COVID-19 serology tests.  Serology tests detect the presence of antibodies to SARS-CoV-2 and do not detect the virus itself, meaning that the tests should not be used to diagnose or exclude acute COVID-19 infection.  

Finalized policy and implementation guidance related to blood and blood component donation.

  • Under FDA standards, blood donors are screened to evaluate potential risk factors for both donor and recipient, which historically could result in a prohibition from donating for a set time period based on identified risk factors, including those with increased risk for transmitting HIV infection. In that vein, the Agency has recently finalized two guidance documents in a move toward individualized donor assessments (IDA) within the US blood system. Substantively, the final guidances track very closely to the draft versions. 

  • Notably, the Agency recommends reducing time-based donation deferrals to 3 months (from 12) for individuals who report either a new or multiple sexual partners in the last 3 months who also report engagement in anal sex, as long as they meet all other eligibility criteria. The new recommendations also defer any individual taking either pre- or post-exposure prophylaxis (PrEP or PEP), for 3 months (or 2 years for long-acting injectable formulations of these medications). 

  • In addition to the final policy guidance, FDA issued implementation guidance adopting a new Blood Donor History Questionnaire (DHQ v4.0) that reflects these changes in policy and outlines next steps for implementing the new DHQ using the IDA approach. While not a requirement, registered blood establishments can begin to implement FDA’s policy changes through adoption of DHQ v4.0 and its accompanying materials; depending on how an establishment implements these changes will determine their associated regulatory requirements (eg, reporting in an annual report if implementing with no or minor modification). 

Final guidance on the testing of high-risk drug components for diethylene glycol and ethylene glycol.

  • On May 19, 2023, FDA published issued final guidance, entitled, “Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol."

  • The final guidance was published in response to numerous recent reports of diethylene glycol (DEG) or ethylene glycol (EG) contamination in oral liquid drug products, primarily indicated for children.

  • The guidance contains recommendations for DEG and EG testing and reiterates GMP requirements related to their detection.

Small Entity Compliance Guide for the implementation of the Food Traceability Rule.

  • On May 18, 2023, FDA published a Small Entity Compliance Guide for the upcoming implementation of the Food Traceability Rule.

  • The Compliance Guide provides key terms and definitions from the final rule and answers around 50 questions related to the Rule's implementation.

  • FDA provides guidance regarding the rule's applicability and exemptions along with detailed compliance requirements for entities subject to the rule.