In light of the publication of HHS' blueprint to reduce drug prices, the FDA has announced the issuance of 2 final guidance documents to provide greater clarity on medical product communications.
In light of the publication of HHS's blueprint to reduce drug prices, the FDA has announced the issuance of 2 final guidance documents to provide greater clarity on medical product communications.
The first document, entitled “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions and Answers” seeks to answer common inquiries the FDA receives from insurers and other industry stakeholders regarding a pharmaceutical company’s drug or medical device. In addition, the guidance also provides answers to questions from industry stakeholders related to a medical product that has not been approved yet.
“We have heard from some manufacturers that in the absence of clear guidance from the agency, they were inhibited from sharing certain economic and other information and, potentially, even from generating additional rigorous data for payers to evaluate in determining the value of a product to their health plans and their beneficiaries, and then to tie value-based contracts to these measures,” according to a statement from FDA Commissioner Scott Gottlieb, MD.
In addition, Gottlieb said, the FDA believes the information provided by manufacturers to payers about their medical products is critical, and therefore must be both truthful and accurate while also including enough background information to allow payers to make informed decisions.
The second guidance document, “Medical Product Communications That Are Consistent With the FDA-Required Labeling,” provides an overview of the FDA’s viewpoint on how manufacturers should share information about a medical product that isn’t included in the product’s label (but is consistent with that labeling).
According to the guidance, while the labeling of a medical product includes essential information about the product to ensure safe and effective use, it is not required that the label includes all information known about the product.
Some information not included in a product's label may still be beneficial to payers to help inform purchase decisions or serve as a basis for value-based contracts; this information can include data from post-market studies and surveillance of a product’s approved uses, or additional information from premarket studies.
“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,” stated Gottlieb.