Off Label Promotion Profitable Health Jeopardizing Act...

Off-label promotion: profitable health jeopardizing act of defiance or costly freedom of speech? INTRODUCTION Over the years there is the discussion on the nature of off-label promotion. Promotion for an unapproved by the Food and Drug Administration usage of a drug, medical device or biologic is prohibited by the 1938 Food, Drug and Cosmetics Act, and subjects the product to the misbranding provisions. On the other hand, off-label promotion is deemed to be a constitutional right protected by the First Amendment. Numerous debates, lawsuits and court rulings still don’t clear up the dilemma of off-label promotion. HISTORY OF OFF-LABEL PROMOTION REGULATIONS Off-label use of drugs and medical devices is common practice in the United States.†¦show more content†¦Another law that imposes liability on healthcare manufacturers is the False Claim Act also known as Lincoln Law. Initially, the law was applied to people who defraud federal programs but in the late 90s the Act commenced to be applied to frauds associated with the promotions of the healthcare goods. The first recognition of off-label promotion was made in 1996 when Franklin v. Parke-Davis lawsuit was filed. Dr. David Franklin filed the False Claim Act case based on his concerns on his former employer’s, pharmaceutical company Parker-Davis, off-label promotion of anti-epileptic drug Neurontin. The proposed claim that off-label promotion complies with the False Claim Act was new and controversial. It took 8 years of legal disputes to attain equally beneficial settlement of $430 million in fines and penalties. The Franklin v. Parker-Davis case set a precedent for nume rous off-label promotion cases, which still remain urgent matter for both lawsuits and public debates. CLAIM ONE Off-label promotion is law-prohibited action, which is used to increase sales profits. The numerous cases were filled against the giant multinational corporations with allegation in fraud, kickbacks, noncompliance with established laws and regulations. Companies tend to commit the same mistakes year after year despite the existing precedents. What motivates manufacturers to take illegal actions? Why