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in learning more about the FDA’s views on communications regarding medical products, the Agency has released two draft guidance documents on the subject.
The first draft guidance, entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers,” addresses a number of frequently asked questions and the associated answers related to medical product communication between firms and payors – details on this draft guidance can be found in our preceding FDA News article.
The second draft guidance is also presented in question and answer format, and discusses the Agency’s evaluation of medical product communication that is consistent with the product’s FDA-required labeling, but that is not included in the labeling.
FDA-Required Labeling
In this draft guidance, the Agency states that “the FDA-required labeling is the primary tool that FDA uses to communicate the essential information needed for the safe and effective use of the product, and firms have an obligation to update their FDA-required labeling as needed to ensure it is not false or misleading.” In order to ensure that the labeling effectively communicates the information, the content is subject to certain requirements and limitations. Furthermore, FDA notes that it is not “intended to be an exhaustive summary of all that is known about a product for its approved or cleared uses.”
It has recently been brought to the Agency’s attention that many medical product firms are “interested in communicating, including in their promotional materials, data and information about the approved/cleared uses of their products that are not contained in their products’ FDA-required labeling.” As such, many of these firms have questions about how the FDA determines when communications containing data and information that are not in the labeling are consistent with the labeling. Additionally, firms also want to know how the Agency views these communications.
Q & A
The FDA acknowledges that there are a large number of unanswered questions, and has provided this draft guidance to provide firms with clarity on the topic. Some of the questions included in the document are as follows:
What FDA-regulated products fall within the scope of this guidance?
“This guidance applies to drugs and devices for humans, including those that are licensed as biological products, and animal drugs (collectively, medical products).”
How does FDA determine whether a firm’s communication about a medical product is consistent with the FDA-required labeling for that product?
There are three factors that the FDA uses to determine whether a communication is consistent with the product’s FDA-required labeling. In order for a communication to be considered consistent with the labeling, it must satisfy all three of the following factors:
- How the information presented in the communication compares to the information about certain conditions of use in the FDA-required labeling. FDA notes that if the answer to any of the following questions is yes, the communication is not consistent with the FDA-required labeling.
- “Indication - Do the representations/suggestions about the product in the communication relate to a different indication than the one(s) reflected in the product’s FDA-required labeling?”
- “Patient Population – Is the patient population represented or suggested in the communication outside the approved/cleared patient population reflected in the FDA-required labeling?”
- “Limitations and Directions for Handling/Use – Do the representations/suggestions in the communication conflict with the use limitations or directions for handling, preparing, and/or using the product reflected in the FDA-required labeling?”
- “Dosing/Administration – Do the representations/suggestions about the product conflict with the recommended dosage or use regimen, route of administration, or strength(s) (if applicable) set forth in the FDA-required labeling?”
- “Whether the representations/suggestions in the communication increase the potential for harm to health relative to the information reflected in the FDA-required labeling.”
- “Whether the directions for use in the FDA-required labeling enable the product to be safely and effectively used under the conditions represented/suggested in the communication — If the answer is no, that indicates the communication is not consistent with the FDA-required labeling.”
Does FDA view firm communications that are consistent with the FDA-required labeling, alone, as providing evidence of a new intended use?
No. Furthermore, FDA also states that it “does not view a communication that is consistent with the FDA-required labeling as failing to comply with the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) requirement that a medical product’s labeling bear adequate directions for use (see section 502(f) of the FD&C Act) based solely on the fact that it presents data and information that are not reflected in the product’s FDA-required labeling.”
What does FDA recommend that firms consider when developing communications that are consistent with the FDA-required labeling to help ensure that the presentation of this information does not render the communication false or misleading?
The way in which information is presented affects how it is understood. As such, the FDA provides a number of recommendations to consider when developing presentations of information consistent with the FDA-required labeling. These recommendations are intended to help firms ensure that their presentations are not misleading. For additional details on FDA’s specific recommendations, view the full draft guidance.
In addition to the questions and answers provided above, the Agency’s document also contains information on several other frequently asked questions. For details on the rest of the questions and answers included in FDA’s draft guidance, view the full document.
Developing the FDA-required labeling and ensuring that you are in compliance with all of FDA’s regulatory requirements can be a challenging task. We can help. To learn more about our services and how we can help you, contact us today.
