3. FDA amends citizen petition rules

The FDA announced an amendment regarding citizen petitions that will impact branded drug makers. A citizen petition is supposed to be submitted to the FDA if the safety or efficacy of a drug is in question. The drug is then delayed or blocked from going to market. Some companies have instead used this process as a tactic to protect sales of their drug against would-be competing biosimilars and generics. But effective January 9, 2017, a citizen petition will not be considered if the drug in question “[does] not raise valid scientific and/or legal issues.” Industry lobby group PhRMA has issued requests regarding the amendment, most of which the FDA has rejected. You can bet the battle is far from over with companies’ patents in play.