FDA To Hold Two-Day Hearing on Off-Label Communications

By Anne K. Walsh & Andrew J. Hull –

FDA announced in an August 31, 2016 notification (“Notification”) that it will convene a public hearing to address its authority to regulate communications regarding unapproved uses of approved or cleared drugs and medical devices. The public hearing will take place on November 9 and 10, 2016, and FDA will take written comments from those unable to attend the hearing until January 9, 2017.

This public hearing comes in the midst of an ongoing debate between FDA and industry surrounding FDA’s authority to restrict the speech of drug or medical device manufacturers related to the unapproved or “off-label” use of their otherwise approved or cleared products. We have posted regularly on these developments, particularly in light of FDA’s significant losses in cases where it has attempted to regulate companies that promote their products for off-label uses (see our previous posts here, here, and here; but see our post discussing the government’s recent prosecution of Acclarent, Inc.’s executives). Those cases have demonstrated the power of the First Amendment, and have held that companies may distribute truthful, non-misleading information about off-label uses of their products without running afoul of the Federal Food, Drug, and Cosmetic Act.

This public hearing appears to be another step in FDA’s long review of these issues:

As we announced in 2014, FDA is currently engaged in a comprehensive review of the regulatory framework related to firms’ communications about unapproved uses of approved/cleared medical products—medical products that may be legally introduced into interstate commerce for at least one other intended use. The purpose of this review is to help ensure that our implementation of FDA Authorities (including promulgating and amending regulations, issuing guidance, developing policies, and taking enforcement action) best protects and promotes the public health in view of ongoing developments in science and technology, medicine, health care delivery, and constitutional law.

Notification at 5. At this rate, it seems unlikely there will be any final pronouncements made until well into 2017.

In the Notification, FDA repeats its oft-stated acknowledgment that the dissemination of information regarding off-label use of an approved or cleared drug or medical device can play an important role in promoting the public health. FDA notes that “relevant, truthful, and non-misleading scientific or medical information regarding unapproved uses of approved medical products may help health care professionals make better individual patient decisions.” Id. at 8.  FDA notes, however, that “[n]ot all communications of information about unapproved uses help support public health.” Id. at 9.  For example, FDA realizes that some communications may emphasize a manufacturer’s claims about the benefits of using its product without disclosing potential consequences:

For example, communications that emphasize a medical product’s claimed benefits, while minimizing the limitations of the supporting evidence, or minimizing the product’s known or potential adverse effects, may inappropriately influence prescribing or use decisions in a manner that is not in a patient’s best interest.

Id. Accordingly, FDA seeks comments on both the pros and cons of communications regarding unapproved uses, and is specifically requesting empirical evidence demonstrating the impact of these types of communications. Id.

FDA lays out nine categories of issues, posing about thirty questions that it hopes will be addressed through the public hearing and comment process. FDA requests feedback from a broad group of stakeholders, including “health care professionals and professional societies, patients and their caregivers, patient advocates, representatives from regulated industry, health care organizations, payors and insurers, academic institutions, public interest groups, and the general public.” Id. at 10.

Notable questions include the following:

• What are the drawbacks and risks of making more information related to unapproved uses of drugs and medical devices available to practitioners, payors, and patients? What safeguards can be put in place to mitigate these drawbacks and risks?
• What effect will increased communications have on patient incentives to enroll in clinical trials?
• How do these changes affect incentives for firms to seek FDA approval or clearance of new uses?
• What criteria should FDA consider in determining whether a study or analysis that is the basis of a firm’s communication is scientifically appropriate to support the presentations or conclusions in the communication?
• What information is most important to health care professionals and other entities in allowing them to judge the validity and utility of firms’ communications about unapproved uses, and why?
• What information should firms communicate to make audiences aware that the product is unapproved for the use discussed?
• What information should firms disclose in order to make sure audiences are not misled (e.g., product risks, nature and weight of evidence supporting unapproved use, regulatory history relating to unapproved use, and financial involvement of firms in described research)?
• How should FDA monitor firms’ communications about unapproved uses, and what actions should FDA take with respect to communications it determines are false or misleading or otherwise raise public health issues?

Some of these questions are similar to those FDA raised in its 2011 request (“2011 Request”) for comments on communications and activities related to off-label uses of marketed products. See Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed; Request for Information and Comments, 76 Fed. Reg. 81508 (Dec. 28, 2011). Similar to FDA’s recent Notification, its 2011 Request sought comments on the types and quality of data that should be considered part of the scientific exchange of information, as well as on how FDA should treat these types of exchanges.  A noticeable difference between these two sets of requests for comments is that the 2011 Request specifically asked for industry opinions on the “distinctions” and “boundaries” between “scientific exchange and promotion.”  The current Notification, on the other hand, does not address the issue of promotion, but instead focuses on the dissemination of truthful and non-misleading information—a shift in terminology and approach that is likely the byproduct of the recent litigation regarding alleged off-label promotion and the First Amendment.

Another difference from the 2011 Request is that the Notification explicitly identifies a concern that a less-stringent regulatory control of off-label communications would have a negative impact on the development of high-quality scientific studies of these uses.

The types of questions that FDA is opening up for public comment suggest that FDA is significantly reshaping its approach on regulating a company’s off-label communications. Given congressional scrutiny (see our post here) and recent litigation, it is not a surprise that FDA is soliciting additional comments.

Attendance at the public hearing is free and open to the public. More information on the meeting registration and/or submitting a comment can be found here.