FDA Address
Catherine Gray, PharmD, Acting Director, Office of Prescription Drug Promotion, US Food and Drug Administration
Catherine Gray, PharmD, Acting Director, Office of Prescription Drug Promotion (OPDP) at the U.S. Food and Drug Administration, spoke at the 2024 Pharmaceutical Compliance Congress in April in Virginia about recent developments within the (OPDP) and prescription drug promotion.
The OPDP operates within the Center for Drug Evaluation and Research, which reviews and approves prescription drugs, and is actively involved in numerous cross-collaborative initiatives.
The organization’s mission is to “protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated.”
Policy, Rule, and Guidance Updates
Gray discussed the CCN (clear, conspicuous, and neutral) Final Rule, which was first published on Nov. 21, 2023, and has been amended over the years. The rule requires that the major statement about side effects and contraindications in these advertisements be presented in a clear, conspicuous, and neutral manner.
Unlike the statutory language, Gray said that the final rule does not include the clause stating the name of the drug and the conditions of use. That information is already located in regulations at 21 CFR two 2.1 E 2 and that is not affected by the CCN Final Rule.
There are CCN requirements for ads for human prescription drugs that are presented directly to the consumer (DTC), particularly in TV or radio format, or state the name of the drug and its conditions of use.
TV and radio ads for vet product prescription drugs are not required to comply with CCN, according to Gray. Those ads still need to comply with regulation, they just don’t need to be compliant with CCN, she said.
“Voluntarily communicating the major statement in a clear, conspicuous, and neutral manner in these ads really can enhance consumer comprehension and lead to better informed decision-making regarding these drugs for your beloved pets,” Gray said.
The Major Statement
The major statement requirements must include major side effects and contradictions of a prescription drug within advertisements that state the drug name and conditions of use that are broadcast through media such as radio, television, or telephone communication systems.
Gray said that the CCN Final Rule describes the standards for the manner of presentation of the major statement to be considered clear, conspicuous, and neutral.
Guidance Documents
Gray discussed the “Quant Info” Final Guidance, which was published on June 23. She said the company made small updates to this guidance in December, which included replacing the term “over-the-counter animal drugs” with “non-prescription animal drugs.”
The guidance provides quantitative efficacy or risk information for the control group where applicable, best practice about when this is applicable and presenting probability information in terms of absolute frequencies, percentages, and relative frequencies, formatting quantitative efficacy or risk info, and using visual aids to illustrate quantitative efficacy or risk information.
The SIUU (Scientific Information on Unapproved Uses) Draft Guidance includes communication from firms to healthcare providers regarding scientific information on unapproved uses of approved cleared medical products, questions, and answers.
This draft guidance supersedes the revised draft guidance issued in 2014 titled, “Distributing Scientific and Medical Publications on Unapproved New Uses Recommended Practices.”
This guidance represents a big collaborative effort, Gray said, and it was issued on behalf of all the medical product centers at the FDA.
There is a wide range of products that are covered, which was shorthanded to device, human drugs, and animal drugs. There are also products that are not within scope of the guidance such as products that are granted an EUA.
This guidance represents an enforcement policy and is a safe harbor for firms to share SIU communications with HCPs.
