Drugs

Revisions Sought to Draft Safety Labeling Changes Guidance

David McFarland

— 1 min read
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Pharmaceutical Research and Manufacturers of America says FDA should revise its draft guidance on implementing the safety labeling changes (SLCs) provision included in the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act to promote an efficient and rational regulatory process, and based on the best scientific data. The trade association’s comment letter on the draft guidance calls for revisions to:

  • clarify that the agency may not use the SLC process to narrow indications;
  • expressly recognize that class labeling may be inappropriate where there is a sound scientific basis for differential labeling for different drugs in a class, and to clarify that the timelines for SLCs involving multiple applicants will not be applied rigidly to deny application holders the opportunity to meaningfully participate;
  • state that all labeling supplements should be prior approval supplements;
  • clarify the guidance on SLC timelines and the basis for changes in these timelines compared to the 2013 guidance that will be replaced when this draft is finalized;
  • state that FDA will not publicly announce SLC notifications or orders until completion of the statutory process;
  • explain why FDA considers SLC order letters or SLC notification letters applicable to more than one applicant not to be confidential commercial information;
  • provide that FDA will communicate with application holders before issuing SLC notification letters;
  • confirm that application holders may voluntarily trigger the SLC process to facilitate expeditious FDA review of new drug safety issues;
  • provide a detailed, rather than “brief,” description of the basis for the SLC; and
  • explain how FDA will apply the “public health threat” provision in the statute.

In its comment, the Biotechnology Innovation Organization suggests revisions and clarifications in areas of the guidance that discuss:

  • what constitutes new safety information and how its validity is substantiated; and
  • notification of application holders.

The organization also provided line-by-line comments.

The Yale Collaboration for Regulatory Rigor, Integrity, and Transparency suggests ways to improve regulatory clarity and fairness in terms of notifying application holders of proposed SLCs, as well as whether SLC letters will be disclosed.

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