In late August, the United States Food and Drug Administration (FDA) announced that it will hold a two-day public hearing November 9th and 10th to obtain input from a broad cross-section of the health care industry, including pharmaceutical and medical device companies, doctors, patients, research institutions, health care organizations, and payors and insurers, regarding the appropriate regulation of manufacturers’ communications about off-label uses for their marketed medical products.
This hearing follows a 2014 announcement by the FDA that it was going to engage in a comprehensive review of the regulatory framework related to firms’ communications about unapproved uses of approved or cleared medical products – products that may be legally introduced into interstate commerce for at least one intended use. The FDA is performing this review to ensure that implementation of FDA Authorities “best protects and promotes the public health in view of ongoing developments in science and technology, medicine, health care delivery, and constitutional law.
This hearing also comes amid a series of high-profile losses for the FDA and the DOJ in the government’s attempt to prohibit and criminalize truthful, non-misleading off-label marketing. Take, for example, the Amarin case, where Amarin and the FDA entered into a formal settlement after the Southern District of New York granted a preliminary injunction against the FDA’s threats to treat Amarin’s truthful and non-misleading off-label marketing about Vascepa, as a violation of the Food, Drug, and Cosmetic Act (FDCA). The court ruled that the FDA was impermissibly chilling truthful, non-misleading speech in violation of the First Amendment.
In the notice, the FDA lays out nine categories of issues, posing roughly thirty questions it hopes will be addressed through the public hearing and comment process. Some of the thirty 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 mirror those raised by the FDA in a 2011 request for comments on communications and activities related to off-label uses of marketed products. The questions asked in this 2016 notice, however, signify that the FDA is significantly reshaping its approach on how it regulates off-label communications.
If you are interested in attending or presenting at the public hearing, you must register by October 19, 2016. Electronic or written comments will be accepted after the public hearing until January 9, 2017.