Some States to Allow Off Label Promotion of Drugs: Headache for FDA?  
​​[Posted on: Thursday, February 1, 2018]

Three states, Mississippi, Missouri and Colorado recently proposed bills to allow off-label promotion of drugs. These states are following on the lead established by Arizona that passed a law last March to allow drug companies to legally promote off-label uses of FDA-approved products (drugs, biologics and medical devices) without any fear of prosecution by the state law enforcement. The Arizona law and the new proposed laws do not allow false and misleading statements or force the insurance companies to cover off-label uses, but they prohibit state officials and state medical boards to take any action against a manufacturer or its representatives for truthful and non-misleading statements about off-label use of regulated products. On the face, these rules look in contrast to FDA’s stated policy of prosecuting off-label promotion, however, in recent years; FDA has taken a softer stance towards truthful and non-misleading off-label statements by manufacturers. So, while the Federal government is lagging behind in passing a clear law allowing off-label promotion, in effect, FDA has begun allowing it via enforcement discretion. However, this may not be a good trend in favor of the patients. FDA review of all data in support of all uses of regulated products is an important pillar of reliable and accurate promotional statements by manufacturers. Allowing manufacturers to skip FDA review and directly communicate new uses to patients in effect takes FDA out of the review process and open a door to scrupulous companies trying to promote their products to patients with maleficent intent. The laws are called "Free Speech in Medicine Act" but its impact could be much more than “Free Speech”; it could be low regulation by FDA which in turn could lead to harm to patients, financially and possibly medically. The current laws allowing compassionate use, and allowing doctors to prescribe products off-label are better options than making it legal to make claims not validated by regulators. A better option would be to create a shorter path to approval via use of data from alternate sources, as done by the 21st Century Cures Act of 2016.