Earlier this week, the U.S. Food and Drug Administration (FDA) issued two new final guidance documents that provide greater clarity regarding the FDA’s position and recommendations on drug and medical product communications with payors, formulary committees and others.

In a statement, FDA Commissioner Scott Gottlieb indicated that the guidance documents are a response to the continuing challenge faced by many Americans in accessing affordable, innovative drugs and other medical advancements.   Many in the pharmaceutical and medical device industries have long advocated for additional latitude to communicate information about their products’ value to payors, formulary committees and other entities involved in price negotiation and coverage decisions.

Gottlieb said the guidance will help address prescription drug spending by reducing obstacles to manufacturers.

“In particular, this guidance will inform market participants developing contracts that include value-based arrangements how to communicate information about how a drug might impact outcomes that are important to purchasers like a health plan or hospital, but is not an endpoint that is expressly described in the drug’s approved labeling,” Gottlieb said.

The first guidance, “Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities—Questions and Answers,” answers common questions about companies’ communications with payor entities such as insurance companies and formulary committees.  The guidance is intended to assist manufacturers in providing payors with truthful and non-misleading information about unapproved products and unapproved uses of approved or cleared products that will ultimately allow payors to provide coverage for new products and new uses more quickly after FDA approval or clearance as well as help companies and payors to “establish pricing structures that benefit patients as well as health plans.”

“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.

The second guidance, “Medical Product Communications That Are Consistent with FDA-Required Labeling,” sets out the FDA’s views on drug manufacturers’ communication of information that is not already contained in the FDA-required labeling for their products, “but that is consistent with that labeling.”

Current drug labeling is subject to many requirements and limitations that are regulated by the FDA to ensure that vital information is communicated regarding the safe and effective use of the drug. Labeling standards, per Gottlieb, are “not intended to exhaustively address all that’s known about a product for its approved or cleared uses.” This means that many types of information that may be useful to patients, providers and insurers, such as data from post-market studies, surveillance of a product’s approved uses, or additional information from pre-market studies that was utilized during the FDA approval process, are not present in the labeling. In order to facilitate the communication of this type of information, the guidance provides a number of examples of the types of communication that the FDA would deem consistent with a products labeling and a number that would not.

Gottlieb concludes his statement by indicating that, “these two guidances will provide clarity to companies as they develop communications about their medical products and help ensure that patients, providers and insurers have access to a range of relevant, truthful and non-misleading information from companies about medical products. The aim of our policy is to help facilitate contracting for new medical products that are based on the value that these products are delivering to health systems, providers and especially patients…. The ultimate goal 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.”

The FisherBroyles Pharmacy and Health Care Law team is pleased to keep you informed of important events related to the pharmaceutical and health care industries. The guidance documents discussed above are available on the FDA’s website. We welcome your questions. Please contact any of the following attorneys:

Brian Dickerson, FisherBroyles Partner
Brian E. Dickerson

Anthony Calamunci, FisherBroyles Partner
Anthony Calamunci

Nicole Waid, FisherBroyles Partner
Nicole Hughes Waid

Amy Butler, FisherBroyles Partner
Amy Butler