FDA updates manufacturer communications guidance to emphasize application to devices
The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products. The updates are intended to reflect provisions in the 2023 Consolidated Appropriations Act.
FDA issued the revised draft guidance on 2 June to address common questions about health care economic information (HCEI) that companies are able to share with payors, formulary committees, and similar entities conducting healthcare economic analysis of their approved and cleared products and products before they've been approved or cleared by the agency. The document will replace a 2018 final guidance on the topic due to a congressional mandate and includes new considerations regarding medical device communication.
"Key changes from the 2018 final guidance include updates to reflect revised statutory text that makes the provisions in section 502(a) of the [Federal Food, Drug, and Cosmetic Act] FD&C Act regarding the communication of HCEI to payors applicable to devices," said FDA. "The guidance also includes updates to align its recommendations with the new section 502(gg) of the FD&C Act, which provides that a drug or device won’t be deemed misbranded under section 502(f)(1) because of certain truthful and not misleading information provided to payors."
As with the previous guidance, FDA noted that payors have stated that, in certain situations, they need information on medical products that have not yet received marketing authorization to plan for coverage and reimbursement decisions, including unapproved uses of the products, which may raise public health concerns. The agency said the guidance attempts to balance the needs of industry, payors, and other stakeholders, with its responsibility to protect public health.
"Some firms’ communications regarding unapproved medical products or unapproved uses of approved/cleared medical products may undermine substantial government interests related to health and safety," said FDA.
The agency added that sharing such information could affect the development of robust scientific data on safety and effectiveness, ensuring that the premarket review process addresses the safety and efficacy of each intended use, the integrity and reliability of the product's promotional materials, and lead to healthcare resources being diverted to ineffective treatment.
"FDA recognizes that in certain instances, there can be tension between the public health interests directly advanced by the premarket review requirements and other important interests," said FDA. "For example, as previously discussed, FDA recognizes that in some situations, payors need to plan for and make coverage and reimbursement decisions for medical products and uses far in advance of the effective date of such decisions.
"In making decisions on a population basis, payors can draw on a range of expertise in multiple disciplines that allows them to critically evaluate information presented to them by firms, including an evaluation of the limitations and reliability of that information," the agency added. "FDA recognizes the value of payors receiving truthful and not misleading information about unapproved medical products and unapproved uses of approved/cleared medical products, as described in section 502(gg) of the FD&C Act, in order to inform their decision-making."
The draft guidance addresses questions such as what HCEI is and how it can be communicated, the appropriate scope of such communication for approved and cleared products, and for products that haven't received marketing authorization, and more.
Stakeholders can comment on the revised guidance on www.regulations.gov under docket no. FDA-2016-D-1307 until 3 August.
