White Paper Offers Policy Options on Off-label Dissemination
A Duke-Margolis Center for Health Policy white paper outlines key challenges with current off-label dissemination policies and offers policy options for making real progress. The courts have recently rejected on First Amendment grounds several attempts to enforce certain restrictions on off-label communications, but this has led to uncertainty and “an unsatisfactory and unsustainable patchwork of regulations, guidance documents, and agency practices related to off-label communication, product labeling, and scientific exchange of information,” the paper says. “The absence of settled policy and clear guidance may create additional disincentives for manufacturers to invest in developing better evidence.”
The paper acknowledges multi-stakeholder collaborations such as the Medical Information Working Group (MIWG) that have sought to develop a path forward to achieve clearer policies on off-label communication. FDA approved a petition from the group in 2014 and agreed to examine its rules and policies for areas where it can refine and clarify the distinction between permissible and impermissible off-label dissemination (see story).
One policy option recommended by the paper is for FDA to take administrative actions to clarify its off-label communication policy in line with its stated commitment to address the MIWG citizen petition. It says guidance should be developed around three key concepts: “greater clarity around the definition of ‘labeling;’ a good working definition of ‘scientific exchange’ as introduced in previous documents; and greater detail around the scope of ‘intended use.’”
Another option for FDA is to “increase the clarity of regulatory policy by making relevant information on its off-label policies available as a centralized, clearly structured resource,” according to the paper. “Currently, such information exists in a variety of government documents and filings that leave it to outside commentators to discern a consistent picture in this complicated policy area. To address this, FDA could develop a Web page that links all existing guidance (final or otherwise) in one easy-to-access place, regularly updated and augmented by any subsequent documents as they may be released. The Web page should be stakeholder friendly, built with input from end users of off-label information, and include an adequate summary or overview of the most pertinent information related to off-label regulations.”
Additionally, the paper recommends a “clear process to achieve consistent enforcement of off-label communication policies should be developed across FDA and other relevant federal enforcement agencies. The enforcement environment also includes HHS Office of Inspector General, Federal Trade Commission, Department of Justice and state attorneys general, it notes. “Different enforcement approaches can muddy the interpretation of so-called ‘safe harbor’ provisions for communication, making it more difficult for sponsors not only to take correct steps to avoid enforcement actions, but also to have the confidence to invest in better evidence development,” it adds. “Greater coordination between arms of the federal government and clearer standards for when enforcement action is pursued by and between agencies would help reduce the costs of compliance with communications policy and improve the quality of information to support decision-making.”