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14 May 20248 minute read

FDA Regulatory News and Trends - May 14, 2024

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

CDRH draft guidances clarifying enforcement policies for IVD tests in light of the LDT Final Rule.

  • On May 6, 2024, CDRH released two draft guidance documents clarifying how the Center plans to exercise oversight of in vitro diagnostic (IVD) tests in light of the recently released final rule establishing laboratory developed tests (LDTs) as IVDs under FDA's regulatory jurisdiction.

  • The draft guidance entitled, “Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency,” outlines factors the Center will assess when deciding to issue an enforcement policy regarding test manufacturers offering unapproved tests during a declared emergency under section 564 of the Federal Food, Drug, and Cosmetic Act. Those factors are (1) need, (2) risk, (3) alternatives, and (4) mitigations.

  • The draft guidance entitled, “Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564,” outlines CDRH's enforcement policy for laboratory manufacturers offering certain unauthorized IVDs for immediate response to chemical, biological, radiological, or nuclear (CBRN) agents in the absence of a 564 emergency declaration.

  • IVD manufacturers and those who work with LDTs are encouraged to review both draft guidances to understand how the Agency plans to implement enforcement policies given its oversight of LDTs. Comments can be submitted to the Agency at docket numbers FDA-2023-D-5365 and FDA-2024-D-0083.

Three draft guidance documents for cancer clinical trial eligibility criteria.

  • On April 25, 2024, FDA issued three new draft guidances, titled, “Cancer Clinical Trial Eligibility Criteria: Performance Status,” “Cancer Clinical Trial Eligibility Criteria: Laboratory Values,” and “Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications.” These guidances are part of FDA’s effort to improve the diversity of clinical trial populations by (1) expanding trial eligibility criteria to include patients with a wider range of performance status, (2) selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of diverse trial participants, and (3) determining the appropriate use of washout periods and concomitant medication exclusions.

  • The Performance Status Guidance provides considerations when including patients with low performance status (PS) and lists the potential advantages and disadvantages when including such patients. FDA recommends that sponsors include patients with lower PS in a manner that contributes to a greater understanding of the efficacy and safety profile of the investigational drug while maintaining patient safety.

  • The Laboratory Values Guidance recommends laboratory values to be used as exclusionary criteria only when clearly necessary to mitigate potential safety concerns. The draft guidance provides three specific recommendations when developing laboratory value-based eligibility criteria.

  • The Washout Guidance recommends that sponsors remove exclusions carried over from earlier trials when additional information becomes available and provide alternatives to prohibited concomitant medications in trial protocols.

  • Interested parties should submit comments on or before June 25, 2024.

Draft guidance on composition statements and statements of ingredients.

  • On April 29, 2024, FDA released a draft guidance entitled, “Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs,” which is intended to assist new drug application (NDA) and abbreviated new drug application (ANDA) applicants in submitting accurate and complete composition statements in their applications and corresponding statement of ingredients in the labeling, when applicable.

  • In addition to providing examples and information on submitting updates, the guidance describes best practices for writing composition statements and statements of ingredients, including maintaining consistency, clarity regarding inactive ingredient function, hydration state and amounts, and drug product compositions in annual reports.

  • Further, the guidance provides suggestions on how applicants can provide complete information with the goal of minimizing the number of assessment cycles and communications that are necessary for approval, as well as for ensuring product labels are written clearly.

  • Interested parties should submit comments on or before June 28, 2024.

Two new cell and gene therapy draft guidance documents.

  • On April 30, 2024, FDA published two draft guidances entitled, “Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products” and “Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products.”

  • The first draft guidance provides recommendations for determining the appropriate cell safety testing to support an Investigational New Drug Application (IND) or a Biologics License Application (BLA). In the draft guidance, FDA indicates the testing should be based on a risk analysis that considers the expansion potential of the cells, the reagents that are used to expand the cells in culture, and the number of individuals the cell-based medical product is capable of treating.

    The second draft guidance generally aligns with previous recommendations on strategies to manufacture finished products that are free from viral contaminants. However, this latest proposed guidance focuses on the introduction of human-and animal-derived materials during manufacturing (eg, feeder cells) and specifically excludes considerations of human cells used as starting material.

  • Public comment on each of the draft guidances is requested by July 29, 2024.

Draft Q&A guidance on promotional labeling and advertising considerations for biological reference and biosimilar products.

  • On April 24, 2024, FDA issued a revised draft guidance entitled, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry.” This new guidance emphasizes the importance of connecting any information contained within promotional communications to the specific product to which the information applies.

  • The revised draft guidance replaces an earlier draft guidance issued on February 4, 2020. While the previous draft mentioned that its recommendations applied to interchangeable products, it lacked recommendations specific to interchangeable products. The latest draft guidance states that promotional communications should not imply that interchangeable biosimilars are safer or more effective than non-interchangeable biosimilars with the same reference product and includes an example of incorrect promotional communications for an interchangeable product.

  • Public comment on the revised draft guidance is requested by June 24, 2024.

DEA recommends rescheduling marijuana.

  • On April 30, 2024, Attorney General Merrick Garland recommended reclassifying marijuana from Schedule I to Schedule III. 

  • This action follows FDA’s medical and scientific review of marijuana under what is known as the eight-factor analysis. That analysis, among other things, considers a drug’s abuse liability, which includes its abuse potential (including its history of abuse), pharmacological effect, and overall risk to public health.  

  • FDA first recommended that DEA reschedule the substance from I to III in September 2023.  If the White House agrees with this recommendation, DEA will publish a Federal Register notice and solicit public comment before finalizing the reclassification.

  • Such reclassification would bring notable changes within the cannabis industry, including fewer restrictions on medical research and the availability of tax deductions. While still unclear, reclassification could also pave the way for additional legislation that would allow cannabis providers access to institutional banking and capital markets.  

  • However, without legislative changes to the Federal Food, Drug, and Cosmetic Act, legal barriers remain in regard to adding cannabis to FDA-regulated products, which include foods, dietary supplements, and drugs.