Can We Say That, Now? FDA Draft Guidance Offers Opportunity for Medical Product Companies to Reevaluate Risk Profile for Product Claims
On January 17, 2017, FDA issued a draft guidance entitled "Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers that should be on the reading list for every manufacturer engaged in the marketing of consumer healthcare products. The guidance addresses how FDA will treat medical communications that present information that is not contained within the FDA-required labeling of a product but is, nonetheless, "consistent with the FDA-required labeling" and, in pertinent part, discusses (1) specific examples of the types of communications that FDA would consider to be "consistent with" the FDA-required labeling (e.g., claims regarding the mechanism of action for a product or the product's onset and duration of action), (2) how FDA will exercise its enforcement discretion for such communications and (3) general (but not comprehensive) recommendations to companies wishing to communicate information that is consistent with the FDA-required labeling in a truthful and non-misleading way.
The Draft Guidance also offers several recommendations about the types of evidentiary support that, in FDA's view, are required to substantiate communications that are consistent with FDA-required labeling. Notably, the examples provided by FDA in the draft guidance document reflect a shift away from strict application of the "substantial evidence" test to a more flexible standard that rests on disclosure of context and material limitations on underlying study design. In this respect, the Draft Guidance is arguably closer to standards applied by the FTC to health product claims, as well as the PhRMA-BIO principles on responsible communications to health care professionals issued last Summer. For more information about the Draft Guidance, we invite you to read our recent advisory on the topic, here.
FDA released the draft "Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers" guidance in conjunction with two other very important documents that address product communications by manufacturers: (1) Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; and (2) Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities--Questions and Answers (see also our advisory on the guidance here).
It is possible that the Trump Administration could take different positions than (and, subsequently, alter course from) those taken in these documents. Collectively, however, the documents set forth FDA's current positions on the First Amendment as it relates to manufacturer communications and offer companies an opportunity to reevaluate the types of claims they would like to make for their medical products in the context of FDA's new guidance. The agency is accepting comments on each guidance until April 19, 2017.
© Arnold & Porter Kaye Scholer LLP 2017 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.