FDA recently announced the availability of an important guidance for industry. The document, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers,” updates an Obama era-draft that outlines how companies can communicate off-label health care economic information about their products to drug purchasers like a health plan or a hospital.
The guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers,” provides answers to common questions regarding firms’ communications of HCEI (healthcare economic information) about their approved prescription drugs to payors. The guidance also provides answers to common questions regarding firms’ communications of HCEI about their approved or cleared medical devices to payors. In addition, the guidance addresses common questions relating to firms’ dissemination to payors of information about medical products that are not yet approved or cleared for any use and about unapproved uses of approved/cleared medical products.
There are two changes of note in the document. First, the guidance is expanded and includes medical devices along with drugs. Additionally, the guidance applies to communication about unapproved products or unapproved uses of already clearly drugs or devices.
According to FDA Commissioner Scott Gottlieb: “Taking into consideration the many thoughtful comments from stakeholders on our draft guidance, our final guidance now includes recommendations that are designed to enable truthful, non-misleading and appropriate company communications with insurers across a product’s lifecycle. The goal is to advance public health benefits such as increased cost savings from informed and appropriate coverage and reimbursement decisions. In this way, we can help ensure patients have more timely access to cutting-edge medical technologies. We can facilitate access by helping to reduce the overall cost of providing these benefits to patients. And in promoting access, we will advance important public health goals.”
The guidance specifically addresses how the FDA intends to implement its language for HCEI disseminated in accordance with section 502(a) of the FD&C Act. In particular, FDA notes that an appropriate audience under this section of the law is HCEI that relates to an approved indication and is based on competent and reliable scientific evidence. If a firm disseminates HCEI to this audience, FDA does not intend to consider such information false or misleading.
Furthermore, HCEI should clearly and prominently present the information discussed in the guidance, including study design and methodology, generalizability, limitations, sensitivity analyses, and information relevant to providing a balanced and complete presentation. If HCEI includes material differences from the FDA approved labeling (e.g., new or increased risks, different dosing/use regimens, different endpoints, more-limited/targeted patient populations), it must present “a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug”.