FDA Delays “Intended Use” Rule

The FDA is delaying its plan to amend regulations regarding “intended uses,” and wants your input.

This is a big deal to medical device companies because any ambiguity about intended use on a device label can get you into hot water with the Justice Department in a hurry. A product’s “intended use” matters and the evidence used to glean intended use can have a significant impact on whether the government can regulate the product and its manufacturer.

Take water for example. If you claim the intended use is for quenching thirst, there is no drug or device regulation. But if you claim the water is intended to cure cancer, then the FDA can regulate the product. Take it a step further. If you heard someone claimed it cured cancer, do you have to get FDA blessing for a new label?

The delay announced March 20, 2017, according to an FDA blog from Hyman, Phelps & McNamara, P.C., comes a year and a half after first being proposed by the agency, two months since the final rule was published, one month after objections threatening an Administrative Procedure Act challenge, and one day before the rules would have taken effect.

Citizen’s Petition

As we reported in February, New FDA “Intended Use” Labeling Rule Causes Industry Convulsions, the final rule required manufacturers to “provide…adequate labeling”…if the “totality of the evidence” establishes that a manufacturer objectively intends that a device [or drug] introduced into interstate commerce by him is to be used for “conditions, purposes, or uses other than ones for which it has been approved, cleared, granted marketing authorization, or is exempt from premarket notification requirements.”

Lawyers for industry went into convulsions. The new language gave the FDA broad leeway to determine the objective intent of the person responsible for labeling the product. Do you need a new label if the FDA can prove that you heard that your device was being used in an off-label manner?

Industry groups quickly filed a Citizen Petition asking FDA to reconsider the language in the final rule or indefinitely stay the rule.

Agency Seeks Comment

The FDA agreed to the request for stay, and agreed to delay the effective date of the rule for 60 days to invite public comment on the issues raised in the petition and the specific questions FDA posed in its notice.

The agency is specifically soliciting comments on the following issues:

• How should FDA consider situations where companies distribute medical products without explicit promotional claims?
• What are the potential public health consequences that should be evaluated in determining intended use?
• How do First Amendment considerations apply to the use of non-speech evidence in determining intended use, such as the circumstances surrounding the distribution of a product?
• Is there a distinction between language permitting consideration of “any relevant source of evidence” and “the totality of the evidence”?

The FDA notes that these issues overlap with the parallel docket in which FDA is considering communications about unapproved uses of approved/cleared medical products. That docket is open until April 19, 2017; this docket will accept both substantive comments as well as comments on the decision to delay the rule until May 19, 2017.

To see how to submit your comments, click here.