Stakeholders Praise Intended Use Rule Delay
Four stakeholders are praising FDA’s 1/16 notification of an indefinite delay in the effective date of a final rule setting forth a new method for determining the intended use of medical products. The stakeholders say the delay is warranted given the controversy over a provision in the rule allowing use of a “totality of the circumstances” test for determining a product’s intended use.
Pharmaceutical Research and Manufacturers of America (PhRMA) says the agency should now withdraw the new provision from the final rule and reform its existing regulations to comport with court decisions on intended use as well as First Amendment considerations. “In particular,” the trade association says, “FDA should implement a policy aligned with the 7/2016 PhRMA-BIO ‘Principles on Responsible Sharing of Truthful and Non-Misleading Information About Medicines with Healthcare Professionals and Payers.’ In the absence of expeditious review, we are concerned that maintaining the current regulatory definition will create uncertainty about the level of communication with healthcare professionals that FDA deems permissible and potentially chill beneficial communications.”
The Medical Information Working Group (MIWG) calls on FDA to confirm its current interpretation of intended use while it continues the process of evaluating the many comments received on the final rule. It says the agency should clarify that its current interpretation of intended use is the interpretation that is included in the preamble accompanying the 9/2015 proposed rule. “According to that preamble and its referenced authorities,” the group says, “FDA will not assert a new intended use has been created by the knowledge of the manufacturer, without more, or that a new intended use has been created by such knowledge together with non-promotional speech. In addition, the MIWG believes that FDA should assure that guidance documents and other policy announcements which describe intended use do so only in a manner that is consistent with current FDA policy, as reflected in the proposed rule preamble and cited authorities.”
In its response, Washington Legal Foundation (WLF) says it viewed the final rule as a retreat from positive aspects of the earlier proposed rule. It later supported the agency’s decision to delay the final rule effective date until 3/19. It says it now supports the indefinite delay in the effective date.
WLF says it has two concerns with the final rule: it was not adopted in compliance with procedures required by the Administrative Procedures Act and it announced a new standard that was not a logical outgrowth of anything FDA has said previously.
Finally, AdvaMed says the final rule “departed drastically from the proposed rule, did not provide clear guidance, and swept broadly into permitted and protected exchange of truthful, non-misleading information. A manufacturer’s ‘intended use’ should be determined based upon the manufacturer’s affirmative conduct and firmly grounded on claims made by a manufacturer to promote its products, not a firm’s knowledge of a third-party use.”