On March 20, 2017, the Food and Drug Administration (“FDA”) published a notice in the Federal Register delaying the implementation of the final rule (“Final Rule”) regulating off-label drug promotion until March 19, 2018. The Final Rule was published in the Federal Register of January 9, 2017. The effective date was originally delayed until March 21, 2017 via a notice in the Federal Register of February 7, 2017.
The delay comes in response to a Petition to Stay and for Reconsideration requesting that the FDA reconsider revisions to the Final Rule, which are viewed as giving the FDA broad authority to police off-label promotion. Several industry organizations filed the petition as a result of their belief that the FDA violated the Administrative Procedure Act (“APA”) by not providing adequate notice and an opportunity to comment on the revised “intended use” definition as published in the Final Rule. The current definition states that if a manufacturer has knowledge that a drug or device is used for off-label conditions, purposes or uses, the manufacturer is required to provide adequate labeling for that use. (see 21 CFR §201.128 and 21 CFR §801.4) The FDA originally proposed deletion of this statement in the proposed rule issued in the Federal Register of September 25, 2015; however, when the Final Rule was published in January, the language was retained and amended to include a “totality of the evidence” standard not found in the proposed rule. This new standard, which the petitioners claim is a “new and unjustified legal standard,” allows the FDA to consider any evidence, including internal deliberations, clinical practice guidelines and non-promotional scientific exchange as evidence of intended use to determine if a company engaged in off-label promotional activity.
The FDA states that the intention behind the amendments was to “clarify that FDA would not regard a firm as intending an unapproved new use for an approved or cleared drug or device based solely on that firm’s knowledge that its product was being prescribed or used by doctors for such use.” (see 80 FR 57756 at 57761) Further, the FDA confirms its long-standing position that “in determining a product’s intended use, FDA may look to any relevant source of evidence (see 80 FR 57756 at 57757) (the product’s labeling, promotional claims, and advertising, oral or written statements by a manufacturer or its representatives, circumstances surrounding the distribution or sale of a product, and other relevant evidence).”
An extension to the effective date of the Final Rule was issued by the FDA so that it may receive full public comments on the issues raised in the petition, as well as other comments. Specifically, the FDA is interested in comments on
- How to evaluate “intended use” when medical products are distributed in absence of explicit promotional claims and when there may be circumstances surrounding the distribution or the known effects of a product and/or the context in which the product is sold suggesting an “intended use”;
- The public health consequences and policy considerations associated with the revision of the definition of “intended use”;
- How the First Amendment applies, if at all, to the use of non-speech evidence associated with the distribution of a product in determining “intended use”; and
- Whether there is a distinction between considering “any relevant source of evidence” and “the totality of evidence” and, further, what wording will provide clarity?
Comments and any additional data and information should be submitted by midnight Eastern Time at the end of May 19, 2017.
If you are interested in submitting a comment or have questions about the implications of the Final Rule, please contact:
- Thomas Shrack at (317) 977-1496 or tshrack@hallrender.com;
- Andrea Anantharam at (248) 770-7506 or aanantharam@hallrender.com;
- Cicely Vaughn at (586) 753-0463 or cvaughn@hallrender.com; or
- Your regular Hall Render attorney.
Please visit the Hall Render Blog at http://blogs.hallrender.com/ or click here to sign up to receive Hall Render alerts on topics related to health care law.
