FDA’s Policy for Off-Label Promotion Takes a Deep Dive Public Discussion 
​[Posted on: Thursday, November 17, 2016]

Last week senior officials at FDA, including the FDA Commissioner, spent two full days listening and discussing their policy on regulation of off-label claims with stakeholders. The net result, no clear consensus and ongoing confusion about what the FDA may do next. About 70 speakers representing pharma and biotech companies, patient groups, industry lobbyists, and individuals presented a wide variety of opinions on how FDA should or should not regulate companies using off-label information to promote products. On an average, pharma and biotech companies, along with their lobbyists would like FDA to loosen the rules while the patients would like FDA to make it stricter. Everyone wants more clarity from FDA in the light of the court cases granting reprieve to companies found to use off-label promotion. The irony is that FDA does already have several ways where companies can legally distribute off-label information about their products. But using off-label promotion to go around the FDA review process is unacceptable, as it should be. FDA acknowledged that both on- and off-label information about medical products is broadly available from a wide variety of sources in both traditional and the internet. Companies can and do use all platforms directly or indirectly to talk about their products. In the light of such wide availability of information, it is always a challenge for regulators to control the use of off-label information for commercial use. The industry presented the importance of communicating current information about its products to the consumers citing the benefit to patients; however, none of the presenters clarified why such new information was not presented to FDA first to get an agreement on the importance of such off-label information, and convert it to on-label information. The industry clearly wants to get all information out without waiting for critique by FDA for commercial gains. The FDA questions indicated that FDA is very uncomfortable by uncontrolled information dissemination. The primary concern is that to make commercial gains, companies can underlay, if not overtly hide, the risks of using a drug for uses that have not been fully independently vetted. FDA officials repeated questioned speakers about suggestions to incorporate regulatory review of the off-label information but no credible ideas seem to have been presented. There was talk of creating an independent panel to review off-label information, or to use “established medical opinion” as the basis to allow off-label uses but these ideas did not seem to convince the FDA panel. On the contrary several patient groups and individuals made passionate case about stronger regulation of off-label uses of drugs to avoid adverse events and deaths. Patients would like the off-label information to be strictly prohibited or at least discouraged by prominent warnings on the product labels and other ways. By the end of the second day, it was obvious that there were no clear winners in the argument. FDA is concerned that if off-label information can be easily used by companies, manufacturers will have no incentive to seek formal approval for the same. Recent court decisions have created a legal precedence protecting any information that is truthful and non-misleading even if it has not been formally approved by FDA. However, the court decisions do not provide the carte blanche permission to circumvent FDA review. FDA has released about 6 guidance documents in the last few years to establish the regulatory paradigm for sharing off-label information. This public meeting may likely lead to a few more guidance documents. No big changes expected though. We will find out for sure soon.