On January 18, 2017, the FDA released two draft guidance documents regarding communications concerning medical products. The first draft guidance, entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers,” contains a number of frequently asked questions and their respective answers. FDA broke the questions down into the following categories:
In this section of the draft guidance, the FDA provides a list of 11 related questions that are frequently asked. Some of these questions include the following:
According to section 502(a) of the Federal Food, Drug, & Cosmetic (FD&C) Act, HCEI is “any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug. Such analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention.” Furthermore, HCEI pertains to the economic consequences associated with the clinical outcomes of treating, preventing, or diagnosing a disease.
There are several ways that this information may be presented. These include, but are not limited to:
The draft guidance states that the Agency does not plan to consider information false or misleading if a firm “disseminates to an appropriate audience HCEI that is the type of information within the scope of section 502(a).” In addition, the document states that the following information should be clearly and prominently stated in the HCEI:
If HCEI contains material that is different from the FDA-approved labeling, “a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug” must also be included.
According to the FDA, “this guidance addresses the communication of HCEI to payors, which may include communication of HCEI in the course of discussions between firms and payors related to risk-sharing and other value-based contracts.” However, as the FDA does not regulate the terms of contracts between firms and payors, the draft guidance is not intended to address the topic.
In some situations, sponsors may wish to provide payors with certain types of information regarding their investigational products. The draft guidance provides several frequently asked questions and the appropriate answers regarding this type of communication. The questions included in this section are:
As long as it is unbiased, factual, accurate, and non-misleading, the draft guidance states that the Agency will not object to the following types of information provided by firms to payors prior to receiving FDA-approval:
Firms should provide the following information concerning investigational products:
Additionally, the FDA recommends that firms provide payors with follow-up or updated information as any previously communicated information becomes outdated.
“Communications between firms and payors that represent that an investigational product is FDA-approved/cleared or otherwise safe or effective for the purpose(s) for which it is under investigation would not be appropriate.”
The Agency’s draft guidance includes several other questions and the accompanying answers. For additional information, view the FDA’s full document.
January 25, 2017
After various industry professionals and stakeholders expressed an interest in learning more about the FDA’s views on communications regarding medical products, the Agency has released two draft...
January 5, 2016
In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA. Among those included in the draft...
January 5, 2016
On December 9, 2015, the FDA released a draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance attempts to promote timely,...