Life Science Compliance Update

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January 23, 2014

Transforming Professional Medical Education -- Role of the FDA

Recently, Douglas C. Throckmorton, MD, the Deputy Director for Regulatory Programs at FDA's Center for Drug Evaluation and Research (CDER) gave a presentation titled, "Transforming Professional Medical Education: Role of FDA". Dr. Throckmorton stated the opinions and information in the presentation are his own and do not necessarily reflect the views and policies of the FDA. We have previous written about the FDA and continuing medical education programs in recent years.

Dr. Throckmorton states that CME plays an essential part of staying informed as practitioner. He contends there needs to be a distinguished difference between "promotion" and "education", as the FDA has recognized a separate role in regulating what it defines as "promotion". He also describes the FDA's emerging use of CME as one component to improve the "safe use of medical products."

Dr. Throckmorton cites FDA's 1997 Guidance for Industry-Supported Scientific and Educational Activities and its focus on: (1) Balance; (2) Objectivity; (3) Independency; and (4) Scientific Rigor.

After publishing the agency's Guidance, FDA released the following: "FDA is providing this guidance to describe the Agency's enforcement policy with regard to scientific and educational activities supported by industry. The guidance seeks to clarify the distinction the Agency draws between scientific and educational activities that FDA considers nonpromotional and those that the Agency considers promotional, and to provide guidance on how industry may support such activities without being subject to the labeling and advertising provisions of the Federal Food, Drug, and Cosmetic Act (the Act).

This jurisdictional line is important because the constraints on advertising and labeling, when applied to scientific and educational activities, can restrict the freedom of participants to discuss their data or express their views. In particular, discussions of unapproved uses, which can be an important component of scientific and educational activities, are not permissible in programs that are or can be subject to substantive influence by companies that market products related to the discussion. The Agency recognizes that industry-supported activities can be both nonpromotional and educational."

The presentation continued, discussing FDA's use of educational tools to improve medical product use by prescribers and patients. Specifically, FDA's focused on product labeling and medication guides, relying on Internet communication to disseminate information. Regarding REMS, another topic of great interest on Policy and Medicine, Dr. Throckmorton notes that CME represents a new opportunity for FDA. He cites CME materials developed as a part of REMS, including: "An Introduction to the Improved FDA Prescription Drug Labeling - Additional Information".

Additionally, regarding Opioid REMS, manufacturers were required to make CME materials available for prescribers and patients based on FDA-approved materials. The CME for prescribers to encourage participation and was developed by accredited continuing education providers, based on core messages developed by FDA/NIDA/SAMHSA. The material is now available at the following two links. Dr. Throckmorton notes that resources are needed to create and manage continuing education, and questions should be asked, such as finding out "who takes continuing education" and the "best methods to reach prescribers."

In summary, Dr. Throckmorton states that CME is an essential part of the continuum of physician medical education. FDA has historically used CME in limited ways to educate on prescription of drugs as part of the agency's larger educational efforts. Finally, use of CME as a part of the Opioid REMS represents new approach to education, grounded in the need for the delivery of balanced, scientifically accurate information to prescribers.

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