FDA Plans November Hearing on Off-label Communications
In November, FDA has planned a two-day public hearing to obtain input on off-label communication by drug and medical device companies. An FDA notice says the agency is “engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA’s policy development in this area.”
The hearing is likely seen by many as a delay tactic as FDA has been reviewing its policies on off-label communications since 2014, which followed a court defeat in United States vs. Caronia. In the ruling, the U.S. Court of Appeals for the Second Circuit said the government cannot prosecute pharmaceutical manufacturers and their sales representatives for truthfully promoting off-label use of an FDA-approved drug. Since then, the government has been stung by several off-label and First Amendment prosecution losses in court.
Earlier this year, A Western Texas jury has found Vascular Solutions and its CEO Howard Root not guilty on all federal charges concerning alleged off-label promotions of the Vari-Lase Short Kit (see story). This was a significant loss for the government and FDA because it was hailed as an escalation in enforcement for holding company executives responsible for corporate wrongdoing. And in March, the Amarin decision (see story) affirmed the company’s ability to disseminate off-label communications, including journal reprints, to health care professionals, as long as the communications are truthful and non-misleading.
In its notice about the hearing, FDA says that healthcare professionals already access considerable scientific information about unapproved uses from scientific journals, clinical practice guidelines, and compendia or by requesting that information from firms. “FDA is interested in comment on the extent to which additional communications from firms about unapproved uses can provide access to information that is relevant, scientifically sound, responsibly presented, and provides as full an understanding as possible about the limitations of the available evidence, as well as comment on the extent to which health care professionals currently face impediments to accessing such information, whether from firms or from other sources,” it says. “FDA is interested in comment and information addressing whether and in what ways firms’ communications of unapproved use information are distinct and perhaps provide unique benefits compared to other sources.”
FDA also says it is worried about off-label 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, (which) may inappropriately influence prescribing or use decisions in a manner that is not in a patient’s best interest. FDA is interested in comment on both the pros and cons for public health associated with firms’ communications of unapproved use information and the kinds of limitations or requirements that would be appropriate to protect patients from harm. We are also interested in any supporting data related to these issues. In addition, allowing additional communications about unapproved uses could have other indirect consequences on public health, which are important to understand and anticipate. For example, FDA is interested in information to better understand how increased communications about unapproved uses would impact incentives to conduct biomedical research submitted for FDA review and subjects’ willingness to participate in such research.”
Additionally, FDA says it wants to hear comments on factors that the agency should consider in evaluating whether firms’ communications about unapproved uses of approved/cleared medical products are truthful and non-misleading, including what information firms should disclose in these communications to help ensure audiences are not misled. For example, the notice asks, “what information should firms communicate to make audiences aware that the medical product is unapproved for the use discussed and to otherwise distinguish between the approved/cleared use(s) of the medical product and the unapproved use? How could the means of communication affect a recipient’s ability to distinguish between unapproved and approved/cleared uses or otherwise impede the disclosure of necessary contextual information? What factors are most relevant to determining whether a firms’ communication about a medical product concerns an unapproved use? How do firms evaluate whether or not their communications concern unapproved uses and whether the messages communicated are accurate and non-misleading?”