FDA Means Business on Unapproved Drugs – If You Don’t Believe It, Just Wait and See!

At the urging of the FDA, the Department of Justice (DOJ) filed suit against Sage Pharmaceuticals of Louisiana for the marketing of unapproved new drugs.  The action comes after numerous warnings and a 2000 injunction against the firm for marketing two unapproved drugs.  Failure to recognize that the FDA really meant what it said landed the company and two of its officers in hot water.  See the DOJ press release here.

Ever since 2006, the FDA has made the removal of unapproved new drugs from the market a priority.  Not that they were not taking action against egregious products before, but they publicized the campaign and held public meeting to reinforce that its rigorous enforcement stand would be understood by the industry.  However, firms still continue to sell drugs without approval and some ignore repeated FDA warnings.  Lack of resources leave the Agency in a position of taking enforcement action when it can and usually, the Agency gives firms the chance to voluntarily remove unapproved drugs from the market prior to taking action, unless there is a clear danger to public health.  The FDA has removed hundreds of drugs since the campaign’s initiation in 2006; however, they are also targeting Over the Counter (OTC) products that do not comply to the published OTC tentative final or final monographs. See here for some of FDA’s enforcement actions and their policy statements.