The Secret's Out: FDA Allows Drug and Device Manufacturers to Share HCEI Prior to Product Approval
What is most notable about this guidance is that FDA has taken the position that this type of information may be shared before a product has been approved.
Section 502(a) Federal Food, Drug and Cosmetic Act (recently tweaked by the 21st Century Cures Act) provides a “safe harbor” for certain HCEI, explaining that such information will not be considered false or misleading if, among other things, it relates to an approved indication.
Yet in this new guidance, FDA has indicated that it “will not object” to manufacturers sharing certain types of information about a product even before it is approved.
In relevant part, the guidance provides:
FDA does not intend to object, under 21 CFR 312.7(a) or 21 CFR 812.7(a) or otherwise, to the following types of information about [unapproved products] provided by firms to payors prior to FDA approval or clearance, that is unbiased, factual, accurate, and non-misleading and when presented with information [described below]:
- Product information (e.g., drug class, device design)
- Information about the indication sought, such as information from the clinical study protocol(s) about endpoint(s) being studied and the patient population 436 under investigation (e.g., number of subjects enrolled, subject enrollment criteria, subject demographics)
- Factual presentations of results from clinical or preclinical studies (i.e., no characterizations or conclusions should be made regarding the safety or effectiveness of the product)
- Anticipated timeline for possible FDA approval/clearance
- Product pricing information
- Targeting/marketing strategies (e.g., outreach activities planned to generate prescriber awareness about the product)
- Product-related programs or services (e.g., patient support programs)
[Manufacturers should also] provide the following information to payors when communicating information about investigational products:
- A clear statement that the product is under investigation and that the safety or effectiveness of the product has not been established
- Information related to the stage of product development (e.g., the phase of clinical trial in which a product is being studied and how it relates to the 463 overall product development plan)
This position presents a very big change for the FDA on HCEI. And although this document is only guidance (and therefore not legally binding) and is still in draft, the Agency is not likely to take any enforcement action against communications that comply with the terms of the guidance, even if not technically permitted under Section 502(a) of the FDCA. This guidance will likely open up a whole new avenue for companies to interact with formulary committees and payors.