FDA broadens healthcare economic information safe harbor

In an effort to clear a hurdle to outcomes- and other forms of value-based contracts, and to help payers prepare for new products, FDA Tuesday issued new guidance on healthcare economic information. The guidance creates a broad safe harbor for drug and device manufacturers to communicate truthful, non-misleading information to payers about data that is not on a product’s label, and about unapproved products.

The Health Care Economic Information guidance applies to communications with public and private sector payers, as well as formulary committees, PBMs, technology assessment groups, and similar organizations. It does not apply to communications with patients, the public, or physicians who prescribe drugs for individual patients and who are not involved in making coverage and reimbursement decisions. ...