Drugmakers Seek Clarity on Two FDA Labeling Guidances

Regulatory NewsRegulatory News | 09 September 2019 |  By 

Drugmakers and industry groups are calling for changes to two recent US Food and Drug Administration (FDA) draft guidances on product labeling, one covering instructions for use (IFU) for drugs, biologics and combination products and the other providing recommendations on drug abuse and dependence labeling.
IFU Patient Labeling
In its comments, the Combination Products Coalition (CPC) said it appreciates the aim of the guidance, but requested the agency clarify several issues in the guidance and provide additional recommendations on submitting IFUs for review.
CPC asks that FDA clarify the scope of the guidance and confirm that the content and layout for IFU proposed in the draft guidance, while recommended, are not requirements. CPC also asks that FDA further explain the criteria for determining whether a product requires an IFU.
GlaxoSmithKline (GSK) raises questions about the focus of the guidance being on the content and format of the Word/Structured Product Labeling (SPL) formatted version of the IFU and lacks recommendations for the artwork version that is submitted for combination products as a separate labeling component.
“As the two versions are related in content and graphics but not necessarily in format or layout, it would be helpful for the agency to clarify the intent of this guidance and how it applies to both elements of draft labeling,” GSK writes.
Both CPC and the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) request that FDA revise the guidance to explicitly link to the agency’s recommendations on human factors (HF) studies from other guidance.
IPAC-RS says it would prefer “that guidance emphasize that specific empirical data from human factors (HF) studies carry more weight than the general design principles outlined in this draft,” while CPC says FDA “should allow for supporting HF data to support IFU content or design that may vary or depart from the recommendations made in the draft guidance.”
Drug Abuse and Dependence Labeling
In response to the draft guidance on the content and format of drug abuse and dependence, GSK, Pfizer and Janssen suggest changes for FDA to consider before finalizing the document.
While supportive of the guidance, Janssen suggests that FDA consolidate its use of terminology related to drug dependence, arguing that ICD10 codes for “addiction” should be scrapped in favor of the term “substance use disorder” from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
Janssen also points out that FDA’s 2013 final guidance on implementing the Physician Labeling Rule says that the “Drug Abuse and Dependence section should be omitted for a drug that is not a controlled substance and has no potential for abuse or dependence and asks for FDA to clarify when drugs that are not controlled substances require drug abuse and dependence labeling.”
GSK makes several recommendations for FDA to address in its comments, including suggesting that some of the content provided in the guidance could be part of specific class-wide labelling.
GSK also asks for FDA to clarify “the trigger/timing for updating existing labels with the new content requested by this draft guidance” and how that information should be submitted to the agency.
In its comments, Pfizer suggests that FDA include example text for the Animal Toxicology and Pharmacology subsection of the Nonclinical Toxicology section of labeling that indicates whether data from animal studies would suggest a likelihood for abuse.
Pfizer also asks that FDA provide examples for determining whether specific populations may be more susceptible to abuse than others.
Public Dockets: Instructions for Use, Drug Abuse and Dependence


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