Over the last ten years, major drug manufacturers have been caught promoting some of their medications to physicians for uses other than those uses approved by the FDA based on research and clinical studies. The act of promoting and marketing drugs for off label uses is illegal and its called “off-label promotion.” The reason it is illegal is because until medications are properly tested in peer reviewed clinical studies, the effects of the drugs on humans cannot be properly gauged.
This wrongdoing is bring brought to the attention of our government more and more now by whistleblowers who work for the drug manufacturers and who want to stop the illegal practices. In addition, they can file cases on behalf of Uncle Sam and recover up to 30% of what the government recovers. The companies are now answering for their wrongdoing in courts of law.
Despite this, global pharmaceutical manufacturers still press the doctors to use certain drugs for purposes other than those which are approved. They do so because the practice is so profitable as once a drug is seeded in the use pipeline, then the moneys start to flow in. In the mean time, the companies petition the FDA to be able to run tests, all the while selling the product on the side in secret.
Here are the top five settlements from 2010- 2012:
1. GlaxoSmithKline $3 Billion off label promotion Avandia, Wellbutrin
2. Abbott Labs $1.5 Billion off label promotions Depakote
3. Amgen $762 million off label promotion Aranesp
4. GlaxoSmithKline $750 Million poor manufacturing practices Kytril
5. Allergan $600 Million off label promotion Botox
Jeffrey Newman represents whistleblowers newmanshapiro.com