Monday, October 30, 2017
Michael A. Carrier , Rutgers Law School discusses Five Actions to Stop Citizen Petition Abuse.
ABSTRACT: High drug prices are in the news. In some cases, such as AIDS-treating Daraprim and the life-saving EpiPen, the price increases dramatically. In other cases, which have received less attention, the price stays high longer than it should. In either case, anticompetitive behavior often lurks behind inflated prices.
Brand drug companies have engaged in an array of conduct to delay generic entry. They have entered into agreements by which they pay generics to settle patent litigation and delay entering the market. They have engaged in “product hopping,” switching from one version of a drug to another, often to delay generic entry. And they have restricted their distribution systems to prevent generics from obtaining needed samples.
One of these tools, which has flown under the radar until recently, involves “citizen petitions” filed with the FDA. Although intended to serve the public interest by bringing safety concerns to the agency’s attention, nearly all petitions today that target generic drugs are denied. Despite the low success rate, however, petitions are still able to delay generic entry and hamstring the FDA.
This Essay offers five solutions to address the problem posed by abusive citizen petitions: (1) increasing transparency; (2) shedding light on simultaneous decisions on petitions and generic approval; (3) facilitating the FDA’s summary dispositions of petitions; (4) addressing resource waste; and (5) promoting timely-filed petitions.