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

• By: Staff Editor
• Date: November 15, 2016
• Source: http://www.raps.org/Regulatory-Focus/News/2016/11/14/26184/FDA-Questions-Need-for-Looser-Off-Label-Promotion-Restrictions/

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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."

Current FDA Regulations

Currently FDA limits drug manufacturers to promote their products for their approved use. However, doctors doesn’t have such limitations. They can prescribe the drugs even if there wasn't FDA approval for that specific disease, dosage or demographic.

A number of pharma companies including GSK, Elli Lilly, Pfizer, Johnson & Johnson, Bristol-Myers Squibb and AstraZeneca have been in news lately for off-label promotional activities and violating False Claims Act.

Are the claims made about your pharmaceutical or medical device in compliance with FDA requirements? Is your sales force, the materials they carry and their sales pitch in compliance? Is your marketing department using social media channels such as Facebook and Twitter? The answers to these questions are vital for drug manufacturers in ensuring compliance with FDA requirements.

What's Next?

The agency will compile the recommendations specified during the meeting into a larger document and decide whether it should change the age-old regulations that governs the marketing of off-label drugs and medical devices use.

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