Weekly Policy Update: FDA Releases Important Guidances

The FDA recently announced the release of important guidances, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers,” and “Medical Product Communications That Are Consistent With the FDA-Required Labeling”. The first guidance answers common questions about companies’ communications to payors, including insurance companies, formulary committees and similar entities. The second guidance provides the FDA’s views on manufacturers’ communication of information that is not contained in the FDA-required labeling for their products, but that is consistent with that labeling. Both guidances are critical to outline how companies can communicate off-label health care economic information about their products to health plans, hospitals and other drug purchasers.

Our national industry partner, AdvaMed, was a powerful influence in ensuring that the medical device industry was included in the guidances. AdvaMed worked with FDA and Capitol Hill to encourage explicit policies to support truthful and non-misleading device manufacturer communications, including communications regarding products that are not yet approved or cleared. This is crucial so that our industry can engage in value-based communications with payers and other health care entities.

The initial FDA draft was largely focused on communications from drug companies, which is a vital component. However, it is also crucial that AdvaMed advocated for the inclusion of medical technology. It is important that our entire industry is supported in continuing to foster lifesaving advances and delivering high quality care for our patients most in need.

The FDA states that the “ultimate goal [of this guidance] is to help facilitate a market that is more competitive, based on the outcomes that matter most–the benefit to patients. Helping facilitate appropriate company communications with these audiences may help foster these outcomes, and enable better access to medical products and possibly more affordable options for Americans.”

To learn more about and read AdvaMed’s press release click here.

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Categories: CBSA News