By Anne K. Walsh –
One and a half years since FDA first proposed changes, 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, FDA announced on Monday that it would delay its amendments to the regulations regarding “intended use.” Rather than implement the final rule by March 21, 2017, FDA announced it would delay the effective date until March 19, 2018, and even implied there might be a final rule issued “after” the 1-year delay. 82 Fed. Reg. 14319, 14323 (Mar. 20, 2017).
Why so much hubbub about what evidence can be used to discern “intended use”? Because FDA’s authority to regulate a product as a drug or device hinges on whether the product is intended to be used to diagnose, cure, mitigate, treat, or prevent disease. A famous analogy is water. If water is intended to quench thirst at mealtimes, it is not considered to be a drug. If water is intended to cure cancer, then FDA believes it can regulate the claims being made by the water bottler, inspect the manufacturing facilities, take enforcement action, and potentially impose criminal penalties. So a product’s “intended use” matters, and what evidence can be used to glean intended use can have a significant impact on whether the government can regulate the product and its manufacturer.
In 2015, FDA proposed revising the intended use regulations at 21 C.F.R. §§ 201.128 and 801.4, to remove objectionable language that imputed knowledge to a manufacturer of external uses: “But if a manufacturer knows, or has knowledge of facts that would give him notice, that a [drug or device] introduced into interstate commerce . . . is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug/device which accords with such other uses to which the article is to be put.” This deletion was favorably received by companies who did not believe it fair to impose requirements on a manufacturer based on the uses of a product over which it did not have control.
Yet as reported here, rather than delete the standard in its final rule, FDA inserted new language that added a different standard to the calculus: “And if the totality of the evidence establishes that a manufacturer objectively intends that a device [or drug] . . . is to be used for conditions, purposes, or uses other than ones for which it has been approved, . . . he is required . . . to provide for such device [or drug] adequate labeling that accords with such other intended uses.” Pharmaceutical groups quickly filed a Citizen Petition asking FDA to reconsider the language in the final rule or indefinitely stay the rule.
On March 20, 2017, FDA acquiesced to the request for stay, and agreed to delay the effective date of the rule to invite public comment on the issues raised in the petition and the specific questions FDA posed in its notice. Interestingly FDA asserted that it is “impracticable, unnecessary, and contrary to the public interest” to solicit public comment on the delay itself, but agreed to “accept public comments for a period of 60 days on whether this rule delaying the effective date should be modified or revoked.” 82 Fed. Reg. at 14321. It is unknown on what grounds one could object to the delayed effective date of such a controversial rule given the important open issues that FDA admits remain in the final rule.
In addition to the issues raised by the Citizen Petition, FDA specifically solicits 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”?
With respect to number 4, FDA claimed that the “totality of the evidence” standard is not a change in FDA’s approach regarding evidence of intended use. FDA cited to the preamble to the original proposal in which FDA claimed it set forth the standard that FDA may look to “any relevant source of evidence.” 82 Fed. Reg. at 14320, citing 80 Fed. Reg. 57756, 57757 (Sept. 25, 2015). This clause, however, appears nowhere in the preamble. Instead, there are citations to several court opinions that enumerate the types of information from which FDA can determine the objective intent of the person responsible for labeling the product. All of the examples cited in the preamble already are specified in the intended use regulations (e.g., labeling, promotional claims and advertising, oral or written statements by a manufacturer or its representatives, and circumstances surrounding the distribution or sale of a product). FDA’s addition of a sentence that includes an “any relevant source of evidence” standard or a “totality of evidence” standard renders the preceding language in the intended use regulations superfluous and unnecessary.
As FDA notes, these issues overlap with the parallel docket in which FDA is considering communications about unapproved uses of approved/cleared medical products, discussed here. 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. Thus FDA encourages commenters to submit feedback in both dockets.