Amarin v. FDA and Public Meeting On Off-Label Promotion Signal An Important Year For Clarity Around Scientific Exchange and the First Amendment

2015 could prove to be a significant year for how the Food and Drug Administration approaches drug companies’ off-label speech. FDA has stressed that they are in the process of attempting to “harmonize” their promotional guidances with the First Amendment, and recently announced that they will hold a public meeting during the summer to address this issue.  Fast-tracking a potential resolution, Amarin Pharmaceuticals just filed suit against the FDA arguing that the agency’s restrictive interpretations would effectively prevent Amarin from sharing “truthful and non-misleading information with healthcare professionals” that FDA would consider off-label. View Amarin’s complaint against the FDA: Amarin v. FDA Background To be approved by the FDA, a prescription drug must pass a series of rigorous clinical trials that test a drug’s safety and effectiveness for a specific condition and a defined group of patients. But once approved by FDA, doctors may prescribe that drug in a different dosage to treat different conditions and different patient groups. This is known as “off-label” prescribing, and accounts for 10-20 percent of the prescriptions in the United States. While doctors can and do prescribe off-label, FDA prohibits drug manufacturers from promoting off-label indications to these doctors. Despite being in the best position to understand their own products, manufacturer can only be the source of off-label information in a number of narrow excep...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs