Jan. 27, 2017 – The FDA recently announced the availability of draft guidance for industry covering manufacturer communications with payors and formulary committees, which “provides answers to common questions regarding the communication of health care economic information (HCEI) about approved prescription drugs” by manufacturers. The document also addresses manufacturer communications regarding investigational products.
“FDA is aware that payors seek a range of information on effectiveness, safety and cost-effectiveness of approved drugs, including information from firms, to help support their drug selection, formulary management, and/or coverage and reimbursement decisions on a population basis,” the agency stated in a Jan. 19 Federal Register notice. “This information may differ from and may be in addition to the information FDA reviews in order to make drug approval decisions.”
“We’ve been waiting for 20 years for this guidance to implement the FDAMA 114 section of the FDA statute. It’s useful as far as it goes because it will facilitate communication by drug sponsors with the payor communities. But, it takes baby steps and includes additional reporting to the FDA,” said Coalition for Healthcare Communication Executive Director John Kamp.
The notice makes clear that the FDA expects that any HCEI provided by firms to payors is truthful and non-misleading and that communications will not be considered false or misleading if they relate to the FDA-approved indication for a drug, based on “competent and reliable scientific evidence” and if they disclose prominently and conspicuously any material differences between the HCEI and the FDA-approved labeling for the product. The agency also clarified that the FDA “does not intend to use HCEI about approved drugs disseminated consistent with this draft guidance … as providing evidence of a new intended use.”
In the draft guidance, question A.9 asks if HCEI for prescription drugs disseminated in accordance with section 502(a) is considered to be promotion and whether FDA’s requirements for promotional materials apply to HCEI. The answer: “HCEI disseminated in accordance with section 502(a) is promotion, and therefore, is subject to FDA’s requirements for submission of promotional materials.” As such, firms are required to submit HCEI materials to the FDA’s Office of Prescription Drug Promotion using Form FDA-2253.
FDA estimates it will take firms approximately 20 hours to compile and draft the information the draft guidance would require if they choose to disseminate HCEI materials to payors. The agency is accepting comments on this draft guidance by April 19.
“It reasonable to expect that the new administration will use this draft guidance as a starting point for additional guidance that will increase the ability of drug sponsors to share truthful information with the payor communities,” said Kamp.