Mark your calendars: FDA will hold public meeting on off-label use this summer
- Facing industry pressure under 1st Amendment grounds, the FDA will hold a public meeting on off-label use this summer. Currently, off-label prescribing accounts for 10% to 20% of all prescribing.
- However, the FDA punishes what is considered illegal off-label use, and in the last 10 years, 17 companies have paid more than $16 billion in settlements.
- Companies are able to legally communicate about off-label use at medical conferences and in the context of responding to unsolicited questions. In addition, data supporting off-label use is often published in credible, peer-reviewed journals.
The Medical Information Working Group includes Pfizer, Sanofi, Novartis, Johnson & Johnson, Eli Lilly, GlaxoSmithKline, and others. This group contends that there are cases in which off-label uses of drugs makes sense, especially when there is a major cost-differential involved and there is data supporting the safety and effectiveness of a drug in an off-label indication.
In 2012, an appeals court overturned the conviction of a sales rep from Orphan Medical (now Jazz Pharmaceuticals) for promoting off-label usage of Xyrem, which is intended for narcolepsy. The basis was protection of First Amendment rights.
On the other side of the argument, there are those who say that allowing off-label marketing could lead to a higher risk of death. One example was the habit of off-label prescribing of HRT to women to prevent cardiovascular (CVD) events. Once a long-term, large-scale study was conducted, it was discovered that HRT increased the risk of CVD events instead of preventing them.
While there are sound arguments on both sides, the FDA public meeting will provide an important forum for staff members to reconsider the rules around off-label communications—an important first step.