Drugs

FDA Featured in 2024 ‘Top-of-Mind Issues’ Report

David McFarland

— 2 min read
Share

A SheppardMullins report on top-of-mind issues for life sciences companies in 2024 highlights several programs and issues involving FDA. The report discusses:

  • CDER Office of Prescription Drug Promotion — A decline in enforcement letters continued, with four untitled letters and one Warning Letter issued to drug companies between 6/2023 and 10/2023. “FDA enforcement efforts on drug product claims and the broader agenda both appear to have been sharpened this year to pick at nuance with the agency’s focus on quantitative efficacy data and audience-appropriate presentation of the same, especially in direct-to-consumer advertising, making it clear that so-called ‘consistent with labeling’ messaging must be accompanied with the appropriate context as described by FDA in its 2018 CFL (consistent with FDA-required labeling) guidance,” the report says.
  • Enforcement Activity Promoting Generic and Biosimilar Competition — FDA supported a 2023 Federal Trade Commission policy statement on Brand Pharmaceutical Manufacturers’ Improper Listing of Patents in Orange Book, warning drug companies they could face legal action if they improperly list patents and outlining some potential enforcement methods.
  • Laboratory-Developed Test Regulation — FDA issued in 2023 its proposed rule outlining the regulatory framework and implementation plan for laboratory-developed tests (LDTs). “This rule, if finalized, could have a significant impact on the operations of LDT manufacturers, as LDTs have historically been a product category for which FDA has exercised enforcement discretion,” the report says. “Unsurprisingly, the proposed rule has received considerable pushback and has garnered more than 6,000 official comments.”
  • Scientific Information on Unapproved Uses — draft guidance was issued. SheppardMullin says the draft is in line with many of the other agency guidances issued in 2023 that memorialized its intent to encourage research and development of new drugs and medical products and the use of novel techniques in doing so. “Manufacturing firms should continue to ensure that all communications are in line with FDA and other federal agency requirements and that firms have compliance programs and policies in place that govern employees’ actions and are in line with regulatory requirements and recommendations…,” it says.
  • Digital Health Software Labeling — is expected to remain a priority in 2024. FDA issued a 2023 Warning Letter to Abiomed for promoting a clinical decision support software package that incorporated remote monitoring functions, including device performance notifications and alarms, without premarket approval.
  • Modernization of the Clinical Trial Process — FDA is seeking to implement novel digital health technologies that can help support patient recruitment and data collection from historically underrepresented populations and develop adaptive clinical trial designs that can address diseases and conditions affecting everyone from the general population to the rare disease population and better predict how medical products developed from the clinical trials will affect the general population. The report says it will be important for companies to monitor FDA enforcement of new requirements to avoid incurring enforcement actions and facing possible delays in agency approval or clearance of a medical product.

Read more