Partners Michael C. Zogby and Chanda A. Miller and associate Katherine McBeth of Drinker Biddle’s Products Liability and Mass Tort Group wrote an article published in the April 2019 edition of For the Defense magazine published by DRI: The Voice of the Defense Bar. In “The FDA’s ‘Medical Product Communications That Are Consistent with the FDA-Required Labeling’ Guidance Document,” Mike, Chanda, and Katherine discussed the FDA’s June 2018 final Guidance Document that provides long-awaited information on how the FDA reconciles a manufacturer’s communications about a product with the product’s FDA-required labeling.
According to the Guidance Document, a pharmaceutical and medical device manufacturer must ask:
- Is the communication about a medical product consistent with the FDA-required labeling for that product?
- Is the communication about a medical product truthful and not misleading?
After analyzing the FDA’s standards, Mike, Chanda, and Katherine provided practical suggestions for how pharmaceutical and medical device manufacturers and their sales and marketing representatives can best communicate the approved or cleared uses for their products in the field.