After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a comprehensive review of its regulations and policies governing off-label communications. As part of the review, the agency recently held a two-day hearing on the subject.
Going into the public hearing, there was both support and a healthy dose of pessimism throughout the regulated industry. Some in the industry were hopeful that the hearing would finally help to clarify the issues, would increase the FDA's understanding of the importance for off-label communications to healthcare professionals and patients, and would lead the FDA to promptly issue long-awaited guidance on the topic.1
The doubters (noting that FDA's guidance on the subject was well overdue) viewed the hearing as yet another stalling tactic that, in conjunction with a new administration and a newly appointed FDA commissioner, could create further basis for delaying required guidance on off-label communications for at least another year. Many wondered what the FDA could learn at this hearing that was not already debated extensively for years and that has been the subject of highly publicized First Amendment litigation. Doubters also pointed to the fact that the meeting notice did not even mention the First Amendment issues as being noteworthy. Indeed, the meeting notice mentioned "constitutional law" only once.
Hearing Highlights
Manufacturers of drugs and devices both noted that the current regulatory restrictions on their ability to communicate in a truthful and non-misleading manner about off-label uses of their products has a significant chilling effect,2and manufacturers are generally the best source of information on all uses of their products.
One manufacturer described a leukemia drug that showed unprecedented success in approximately 96 percent of patients treated off-label. The speaker noted, however, that because the treatment was off-label, the manufacturer was prohibited from informing patients who might benefit from the drug.
Other speakers pointedly reminded the FDA that it is a creature of statute, and as such, is bounded in its authority by law. These speakers also reminded the FDA of its constitutional duty to honor fundamental First Amendment rights, and noted that should the FDA exceed its authority, or trample constitutional provisions, the FDA should immediately expect to be challenged in the courts.
For its part, a number of the FDA's questions dealt with practical measures to implement a safe harbor for off-label promotion, what the metes-and-bounds of the off-label promotion safe harbor should be, and how to best balance the safety of patients with off-label promotions.
Conclusion
Off-label promotion sits at a crossroads. The FDA's traditional position that off-label promotion is prohibited has been repeatedly and successfully challenged in the courts. Nevertheless, companies that promote off-label in a truthful and non-misleading manner still face the prospect of prosecution.
Given that guidance which could create a safe harbor is unlikely to be released by the FDA for at least a year, manufacturers should continue to take appropriate precautions before promoting off-label. Please contact David Hoffmeister or any member of the FDA regulatory practice at Wilson Sonsini for assistance on the promotion or advertising of regulated products.
