In January, FDA released a Draft Guidance on Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities (“Draft Guidance,” available here), which provides the Agency’s thinking on communications with payors in two areas:
(1) communication of health care economic information to payors regarding approved drugs; and
(2) communications to payors about investigational drugs and devices.
We focus here on the second category and how it affects medical device companies. FDA is accepting comments on the Draft Guidance until April 19, 2017.
Manufacturers may seek to communicate with payors (i.e., the entities responsible for financing or reimbursing costs associated with health care services, such as third-party payors and health plan sponsors) on their drugs and devices that have not yet been approved by FDA for any use—“investigational products”—to provide information to help payors plan for future coverage or reimbursement decisions.
Although FDA regulations expressly prohibit promotion of investigational products, historically, FDA provided very little guidance to companies regarding communications with payors in advance of approval. This left companies struggling to craft these discussions so as to avoid running afoul of the prohibition on pre-approval promotion. The Draft Guidance breaks new ground with respect to FDA’s acceptance of certain communications with payors. Companies now have more concrete parameters for communications needed to facilitate decision-making by payors and other entities on product selection, formulary management, and coverage and reimbursement.
As set forth in the Draft Guidance, companies sharing information about investigational products with payors should provide (1) a clear statement that the product is under investigation and that the safety or effectiveness of the product has not been established, and (2) information related to the stage of product development. So long as companies provide this information, FDA does not intend to object to unbiased, factual, accurate, and non-misleading firm communications about investigational products in the form of:
- Product information (such as drug class or device design);
- Information about the indication sought (such as clinical trial subject demographics);
- Factual presentations of results from clinical or preclinical studies (e.g., 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); or
- Product-related programs or services (e.g., patient support programs).
Finally, companies should provide follow-up information to payors if previously communicated information becomes outdated.