AdvaMed last month sent a letter to the FDA criticizing a new rule which changes the group’s definition of “intended uses”, saying it could negatively impact scientific communication, device development and make manufacturer’s liable for any off-label use by merely knowing it exists.
The letter was released last week by the FDA, and is in response to a new rule, finalized in January but delayed for comment, which was originally intended to clarify rules about classifying tobacco products but which altered the definition of “intended uses.”
In an update originally proposed in Sept. 2015, the FDA removed a clause, often referred to as the “knowledge” clause. The clause stated that the agency could regulate products on both intended uses and on actual uses based whether the maker knows or “has knowledge of facts that would give him notice” that the drug, or device, was being used for “conditions, purposes, or uses other than the ones for which he offers it,” according to a Regulatory Affairs Professionals Society post.
The update changes the language to refer to a “totality of evidence”, suggesting that if there is evidence that a manufacturer intended a product to be used outside its intended use, it must be regulated as such and labeled.
“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 rule reads, according to RAPS.
The FDA said the change was intended to indicated that it did not intend to completely remove manufacturer knowledge as a source of evidence, according to the report.
The rule saw a wealth of feedback from both drug and device manufacturer groups.
“The Final Rule’s definition of “intended uses” – which for the first time encompasses a “totality of the evidence” standard – is both overly broad and vague. Far from providing clarity, the Final Rule creates confusion as to what FDA might consider as evidence of “intended use,” including how the Agency will consider communications, such as scientific exchange, that are currently recognized as appropriate and permissible. Moreover, because the “totality of the evidence” standard is more outcome determinative than prescriptive, manufacturers seeking to avoid potential enforcement action will have no choice but to curb important product-related communications,” AdvaMed wrote in its response.
The industry groups that under the new “totality of evidence” rule, companies would be required to significantly limit natural communication about devices, including training sessions, investigational device trial communications and discussions, research and development meetings and discussions and more.
“Such types of communication are critical to fostering the health of patients undergoing treatment, as well as the general public through development of and access to new medical technologies,” AdvaMed wrote.
AdvaMed went on to criticize the new language saying it could create a standard by which a manufacturer’s knowledge of an off-label use would be potentially criminally incriminating.
“For all of these reasons, AdvaMedi strongly urges FDA to abandon the vague and overly broad “totality of the evidence” standard articulated in the Final Rule and revert to the approach set forth in the Proposed Rule,” AdvaMed wrote.
AdvaMed suggested that if it the FDA did not wish to revert its language, it should add clarity to protect scientific exchanges and communications, as well as truthful, non-misleading communications, and establish that “mere knowledge of unapproved use by third parties do not constitute evidence of an “intended use.”