How to Safely and Productively Promote an FDA-Regulated Medical Product
As any medical product business knows, compliance with the AdvaMed Code of Ethics (the “Code”) is essential. While the Code is voluntary, many states require medical product manufacturers and companies to adopt compliance programs consistent with the Code. On January 9, 2019, AdvaMed announced revisions to its Code of Ethics. The amendments will be effective January 1, 2020 and include the following:
- Clarifications as to when a legitimate need for consulting services. The amendments do not consider arrangements to create business or reward referrals to be legitimate needs for consulting services;
- A new section on jointly conducted education and marketing programs requires that there be a bona fide relationship between a medical product company and a health care professional. The bona fide relationship should be documented in writing and contributions and costs should be equitably shared between the medical product company and the health care professional;
- A new section on communication regarding the safe and effective use of medical products requires medical product companies to create policies and controls to ensure that truthful and non-misleading information is distributed and communicated to health care professionals. The amended Code recognizes that such information is essential for health care professionals ability to make treatment decisions;
- A new section regarding technical support provided by the medical product company establishes that all technical support must be done in a transparent manner and prohibits the medical product representatives interfering with the clinical decision making of a health care professional;
- A checklist for medical product companies to aid in compliance and evaluation of requests for support of third-party educational programs and other conferences; and
- Clarifications on when a medical products company may pay for travel and lodging and increased guidance regarding appropriate venues for meeting.
Given the challenges in maintaining compliance in today’s regulatory environment, our colleagues, Bethany Hills, Joanne Hawana and Benjamin Zegarelli have published a book to help medical product companies comply with burdensome and nuanced FDA obligations associated with launching and promoting medical products. The book provides a complete overview of (i) regulatory authorities and legal and regulatory requirements; (ii) the compliance principles for promoting and labeling medical products; and (iii) how to guidance in targeting health care professionals, consumers and sophisticated audiences for promotion. Corporate counsel, product managers, regulatory professionals, and product marketing professionals will find the book useful and resourceful in their daily practice.