Shifting Regulatory Landscape for Off-Label Promotion Continues
On Wednesday, July 12, 2017, the Health Subcommittee of the Energy and Commerce Committee held a hearing to discuss proposed legislation that would impact the regulation of off-label use and promotion for drug products. There were representatives from all facets of the industry discussing the potential impact of decreasing regulation of off-label use of drugs and how it could affect patients, the public, manufacturers, and the economy.
The FDA last solicited public comment on the issue of off-label use over six years ago, and the proposed bill is meant to help clarify certain confusion that has existed between the current regulations and more recent court rulings that appear to contradict and conflict with the current regulatory scheme. The bill, in its current form, seeks to reduce regulation in order to facilitate growth for potential uses once the at-large public is exposed to a drug that may otherwise not be discovered in controlled, limited testing prior to release of the product. Supporters also point to regulation causing improper restrictions of free speech, and an unnecessary chilling of economic growth opportunities for the manufacturers. Opponents of the bill are concerned that decreasing regulation could expose patients and the public to riskier practices and potentially harmful consequences.
Though not explicitly discussed during the hearing, a natural consequence of the proposed bill would be the impact that relaxation of off-label promotion restrictions would have on liability concerns for life sciences companies, as current penalties for off-label promotion can be quite significant. Thus, if and when the rules change for off-label promotion, companies will want to be sure they understand the impact of those changes so that they, and their employees, can operate accordingly.