The Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act would curb the abuse of the Food and Drug Administration’s (FDA) petition process while preserving the opportunity to submit legitimate claims raising public health concerns
WASHINGTON – Today, U.S. Senator Amy Klobuchar (D-MN), Ranking Member of the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, and Senator Chuck Grassley (R-IA), Chairman of the Senate Finance Committee, announced that their legislation to increase access to affordable prescription drugs by curbing abuse of the Food and Drug Administration’s (FDA) petition process has passed the Senate Judiciary Committee. The Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act would reduce the incentives for branded pharmaceutical companies to file sham petitions with the FDA to interfere with the regulatory approval of generics and biosimilars that would compete with their own products, a tactic that delays patient access to more affordable medications. The bill would give the Federal Trade Commission (FTC) enhanced authority to take action against those who file sham petitions.
“Increasing competition is a critical element of bringing down the skyrocketing cost of prescription drugs—but that can only happen if we eliminate incentives for bad behavior, like submitting wasteful sham petitions that can delay the introduction of new generic and biosimilar alternatives,” Klobuchar said. “The bipartisan Stop STALLING Act will give the FTC increased authority to crack down on these abusive practices, helping to ensure that drug makers will think twice before submitting sham petitions that have more to do with increasing profits than improving patient safety. Today’s vote is an important step in moving this bill forward, and I look forward to it passing the entire Senate soon.”
“Citizen petitions exist to promote safety and efficacy of prescription drugs, not to be a tool for drug companies looking to prolong their monopolies over medication and keep lower-cost alternatives off the market. Sham petitions by drugmakers and their shadow actors to delay approval of more affordable competitors only serve to pad their pockets at the expense of patients. This bill takes important steps to preserve citizen petitions and prevent abuse,” Grassley said.
Specifically, the Stop STALLING Act would:
• Create an FTC cause of action against sham petitions as unfair methods of competition,
• Create a rebuttable legal presumption of illegality for certain petitions referred from the FDA with a finding that they were submitted for the primary purpose of delaying the approval of a drug application, and
• Grant the FTC the authority to seek civil penalties for violations.
Although interested parties may file petitions with the FDA in connection with its review of certain drugs, concerns have been raised that pharmaceutical companies file serial petitions or last-minute petitions in attempts to delay generic approval, while imposing significant and unnecessary review costs on the FDA.
The bill is endorsed by Consumer Reports, Public Citizen, Patients for Affordable Drugs, and the Campaign for Sustainable Rx Pricing.
Companion legislation in the House of Representatives is led by Representative Hakeem Jeffries (D-NY), Chairman of the House Democratic Caucus; Representative Jerrold Nadler (D-NY), Chairman of the House Judiciary Committee; Representative Doug Collins (R-GA), Ranking Member of the House Judiciary Committee; Representative Jim Sensenbrenner (R-WI), Ranking Member of the House Judiciary Subcommittee on Antitrust, Commercial and Administrative; and Representative Peter Welch (D-VT) and passed the House Judiciary Committee on April 30.