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. Either way, anticompetitive behavior often lurks behind inflated prices.

By delaying price-reducing generic competition, this behavior forces consumers to spend billions of extra dollars each year. Brand drug companies have engaged in an array of conduct to delay generic entry. They have entered into agreements by which they pay generic manufacturers 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.

Another one of these strategies, which has flown under the radar until recently, involves “citizen petitions” filed with the U.S. Food and Drug Administration (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, petitions are still able to delay generic entry and hamstring the FDA.

This Piece provides an overview of citizen petitions and the anticompetitive harm they threaten and offers five solutions to address the problem posed by abusive 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.

Keywords: citizen petitions, pharmaceuticals, drugs, FDA

JEL Classification: I18, K21, L40, L41, L43, L65, O34, O38