The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have petitioned the US Food and Drug Administration (FDA) following its “unexpected decision” last month to revise the definitions of “intended use” for drugs and medical devices.
The industry groups call for this final rule to be stayed indefinitely and reconsidered because FDA failed to give fair notice or a meaningful opportunity to comment on this major shift.
“The Final Rule significantly altered course, changing the definition of intended use by introducing a new, and overly broad, ‘totality of the evidence’ standard that is not found in the FDCA [Food, Drug and Cosmetics Act] and allows FDA to consider any evidence, including knowledge. Furthermore, the Final Rule restores to the regulations the command that manufacturers provide ‘adequate labeling.’ These changes were not hinted at in FDA’s proposed rule, which promised only a modest clarification to the agency’s intended use regulations.
“The agency therefore failed to give regulated parties fair notice of a fundamental change to the regulatory scheme for drugs and devices. The revisions contained within the Final Rule thus violate the fundamental principle that agencies may not ‘use the rulemaking process to pull a surprise switcheroo,’” the petition says.
In September 2015, FDA published a notice of proposed rulemaking, explaining that changes to 21 C.F.R. §§ 201.128 and 801.4 were needed “to reflect how the agency currently applies them to drugs and devices.”
Citing its own briefing from a case settled by the agency with pharma company Allergan, FDA said it would no longer “regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use.”
FDA proposed altering the definition of intended use, with the key to industry being a deletion of a final line stating: “if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him 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 which accords with such other uses to which the article is to be put.”
And such a dramatic shift in FDA's thinking was not just a surprise for industry groups. The FDA Law Blog noted in October 2015: "It is also remarkable that FDA provides almost no explanation for the proposed revision to the intended use regulations, considering that it is a fairly significant alteration to regulations that have been on the books for decades."
On 9 January, however, FDA “dramatically shifted gears,” according to the petition. “Rather than delete the final sentence of the intended use definition, the agency replaced it with an entirely new sentence,” which PhRMA, BIO and MIWG claim created an open-ended “totality of the evidence” standard.
“And if the totality of the evidence establishes that a manufacturer objectively intends that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it is approved (if any), he is required, in accordance with section 502(f) of the Federal Food, Drug, and Cosmetic Act, or, as applicable, duly promulgated regulations exempting the drug from the requirements of section 502(f)(1), to provide for such drug adequate labeling that accords with such other intended uses,” the new rule said.
The groups said the new “totality of evidence” definition is “a new and unjustified legal standard” as FDA’s final rule “would represent a substantial change with significant constitutional and public health ramifications.”
Petition to Stay and for Reconsideration