The US Food and Drug Administration (FDA) on Tuesday finalized two guidances meant to clarify its policies on communicating medical product information to payors and to inform industry on how to communicate information about products in a manner consistent with FDA-required labeling.
The guidances come as FDA has grappled with how to update its approach to regulating medical product communications after a series of court losses and settlements surrounding off-label promotion and whether such communications are protected by the First Amendment.
Both final guidances include changes from the draft versions
released in January 2017 made in response to industry comments
and attempt to spell out the agency's policies toward communicating medical product information that doesn't fall within approved labeling in a truthful and non-misleading way.
FDA's final guidance on payor communications includes four new questions and answers from the draft guidance meant to elaborate on the agency's policies toward communicating information about unapproved products or unapproved uses of approved products to payors, formulary committees and other similar entities.
FDA Commissioner Scott Gottlieb said the guidance will help address prescription drug spending by reducing obstacles to manufacturers communicating information about their products' value to payors, formulary committees and other entities involved in price negotiation and coverage decisions.
"Payors seek a range of information on the effectiveness, safety and cost-effectiveness of approved/cleared medical products, including information from pharmaceutical manufacturers, to help support product selection, formulary management and/or coverage and reimbursement decisions," Gottlieb said.
Such information, he said, may not always overlap with the information the agency uses to make regulatory decisions about a product.
Gottlieb also drew a distinction between payors and the general public in their ability to interpret and evaluate information about drugs and devices that isn't necessarily included in the product's label.
"The payors who receive this information … are sophisticated parties who have access to a lot of expertise in evaluating this data," he said.
In a change from the draft version, the final payor communications guidance now discusses how drug and device makers can communicate "truthful, non-misleading and appropriate" information across the total lifecycle of their products.
The guidance also discusses how manufacturers can discuss information about unapproved products or unapproved uses of approved products in a truthful, non-misleading manner.
According to Gottlieb, this could help speed coverage decisions for new medical products by enabling payors to review relevant information about unapproved products before they enter the market.
'Consistent With the FDA-Required Labeling' Guidance
FDA also finalized its questions and answers guidance on product communications that are consistent with the FDA-required labeling, detailing the agency's current thinking on the subject through a set of 11 questions and answers.
"Labeling is subject to content requirements and limitations to ensure that it effectively communicates information. It's not intended to exhaustively address all that's known about a product for its approved or cleared uses," Gottlieb said, noting that relevant information about a product from postmarket studies and surveillance may not be present in a product's approved labeling.
Notably, FDA clarifies in the final guidance that it does not intend to rely on such communications as the basis for establishing a new intended use for a product different from its legally marketed use(s), so long as the communication is consistent with required labeling.
This should ease industry concerns that the agency could use such communications to find that a company is marketing a product for an unapproved intended use.
The guidance also provides a number of examples of communications that the agency would consider to be consistent with a product's labeling and ones that would be considered inconsistent with the labeling.
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers
; Federal Register Notice
Medical Product Communications That Are Consistent With the Food and Drug AdministrationRequired
Labeling — Questions and Answers
; Federal Register Notice