One day before the final rule, "Clarification of When
Products Made or Derived From Tobacco Are Regulated as Drugs,
Devices, or Combination Products; Amendments to Regulations
Regarding 'Intended Uses,'" would have taken effect,
the Food & Drug Administration ("FDA" or
"Agency") announced it was delaying the rule's
effective date until March 19, 2018, to obtain public comments on
issues raised in an industry petition and on any other issues
raised with respect to the rulemaking.
In a 2015 proposed rule, the Agency proposed
changing the existing "intended use" regulations for
drugs and medical devices 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.
However, in the final rule published January 9, 2017, FDA did
not to delete the language but, rather, added new language creating
a new and different standard for the rule providing: "And if
the totality of the evidence establishes that a manufacturer
objectively intends that a drug [or device] ... is to be used for
conditions, purposes, or uses other than the ones for which he
offers it is approved (if any), he is required ... to provide for
such drug [or device] adequate labeling that accords with such
other intended uses."
FDA stated that adding the "totality of the evidence"
standard did not change its goals under the proposed rule, and it
clarified that the new language embodies its longstanding position
that "intended use" can be based on "any relevant
source of evidence," including a variety of direct and
circumstantial evidence. (Notably, FDA's original proposed
removal was "to better reflect FDA's interpretation and
application of [the intended use] regulations" and "would
not reflect a change in FDA's approach regarding evidence of
intended use for drugs and devices.")
Notwithstanding FDA's reasoning, industry members petitioned FDA to reconsider the rule, to
revert to the language proposed in 2015, and to stay the final rule
indefinitely. The petitioners claim FDA's final rule violated
the fair notice requirements of the Administrative Procedure Act,
and that the "totality of the evidence" standard is a new
and unjustified standard that would introduce significant
constitutional concerns and negatively affect the public health by
chilling valuable scientific speech.
Consequently, FDA has delayed the effective date of the amended
regulations and is requesting comments specially related to: (i)
how FDA should consider situations where companies and individuals
distribute medical products and/or seek to import medical products
without explicit promotional claims; (ii) the potential public
health consequences and relevant policy considerations that should
be considered in evaluating any approaches to intended use; (iii)
how 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 or the context in which
it is sold; and (iv) whether stakeholders believe there is a
distinction between considering "any relevant source of
evidence" and "the totality of evidence," and
whether there are any suggestions about what wording provides the
most clarity to regulated entities.
FDA also encouraged submitting comments regarding off-label
communications of approved/cleared medical products (see
next story) to also submit their comments to the present docket if pertinent to the specific issues
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).