Pharma industry sees the USFDA draft guidance on disclosing risk information in consumer-directed print advertisements and promotional labeling for prescription drugs as a valuable tool to provide details of the drugs at one-shot to the pharmacist, medical practitioner and the patient.
Labeling is a key part of the regulator’s task and is critical element during inspection of manufacture, sale, and distribution of drugs. The draft guidance mandates print advertisement for a prescription drug must contain a true statement of the product’s quantitative composition, information relating to side- effects, contraindications and effectiveness. For the published direct-to-consumer advertisements, the statement should primarily encourage consumers to report side-effects to FDA.
The regulatory authority now expects pharma and biotech industry to comment on the draft guidance and revert with suitable suggestion before October end 2015.
According to Prema Desai, pharma consultant, the revised draft guidance provides clarification on the information to include in brief summary focusing on the most important risk information and also recommends that the information to be presented in a way that is most likely to be understood by consumers.
As the target audience of the packaging inserts (PI) is health care providers, it is written in highly technical medical terminology, which is potentially of limited value to consumers who may not understand this information, she added.
To provide better and more actionable information for consumers, FDA believes that the brief summary should focus on the most important risk information rather than an exhaustive list of risks. It should be presented in a lucid manner for the consumer’s comprehension. Thus the regulator strongly recommends against the use of the traditional approach to fulfill the brief summary requirement in consumer-directed advertisements on the package insert which is presented, often in small font size.
Generally, the requirements in 21 CFR 201.100(d) have been fulfilled by including the full FDA-approved package insert with promotional labeling materials. For purposes of this guidance, the requirement under these provisions is that a prescription drug promotional labeling piece includes the information set forth in 21 CFR 201.100(d) for prescription human drugs and 21 CFR 201.105(d) for prescription animal drugs, which is generally fulfilled by inclusion of the full PI.
The regulator also provides options to disclose risk information in consumer, directed prescription drug print advertisements and promotional labeling. It encourages use of consumer-friendly language for large target audience with various levels of literacy skills. It calls to avoid use of technical language, scientific terms and medical jargon. The consumer brief summary should provide clinically significant information on the most serious and common risks associated with the product and omit less pertinent information. It also mandates creation of formats like ‘Boxed Warning’, ‘All Contraindications’ and certain information regarding ‘Warnings and Precautions’.