Will FDA Agree to Loosen the Off-Label Promotion Limits?

• By: Staff Editor
• Date: November 16, 2016
• Source: http://www.raps.org/Regulatory-Focus/News/2016/11/14/26184/FDA-Questions-Need-for-Looser-Off-Label-Promotion-Restrictions/

The US FDA recently held a 2-day public hearing to seek input for more flexible regulations on off-label promotion for drugs and devices. Pharmaceutical, medical device, and insurance industries, health and safety advocates, as well as physicians and patients packed a room for two full days at the FDA’s campus to debate on these rules and regulations.

Dr. Robert Califf, the FDA commissioner, said that ultimately, the analysis of the regulations is to ensure that the system "best protects and promotes the public health and the well-being of patients."

Pharmaceutical companies stated that current marketing regulations are too restrictive.

Patients argued that relaxing these regulations would be a "public health disaster."