The Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act seeks to 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 – Senate Finance Committee Chairman Chuck Grassley today joined Senator Amy Klobuchar (D-MN), Ranking Member of the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights in introducing new bipartisan, bicameral legislation to curb the abuse of the FDA petition process and increase access to affordable prescription drugs. 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 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 also give the Federal Trade Commission (FTC) enhanced authority to take action against those who file sham petitions. Identical legislation was introduced today in the House of Representatives by Representative Hakeem Jeffries (D-NY), Chairman of the House Democratic Caucus, Representative Doug Collins (R-GA), Ranking Member of the House Judiciary Committee, Representative Jerrold Nadler (D-NY), Chairman 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).
“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 generics 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.
“The FDA petitioning process offers the public an opportunity to raise legitimate health and safety issues regarding potential new drugs, but for too long some businesses have been using it to advance their commercial interests at the expense of patients and consumers. Increased competition in prescription drug markets can only happen if we eliminate incentives for bad behavior, like submitting sham petitions that delay safe and effective generics and biosimilars from reaching the patients who need them,” said Klobuchar. “The bipartisan Stop STALLING Act will give enforcers 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.”
“No one should be forced to make the unthinkable choice between lifesaving prescription drugs and putting food on the table. The Stop STALLING Act aims to drive down the sky-high cost of medicine by expediting access to affordable generic drugs for everyday Americans,” said Jeffries. “Senators Klobuchar and Grassley, along with Representatives Sensenbrenner, Collins and Welch should be commended for their leadership in this regard."
“The citizen petition process allows the public to raise legitimate scientific and health concerns about drugs under review by the Food and Drug Administration. Instead of serving this important function, this process has often been misused by brand-name drug manufacturers to stifle competition from generics and biosimilars,” said Nadler. “The “Stop STALLING Act” takes an important step toward lowering drug prices and increasing competition in health care markets by addressing sham citizen petitions that slow down or stop the FDA approval process.”
“The Stop STALLING Act prevents brand-name pharmaceutical manufacturers from filing bogus citizen petitions simply to prevent generic options from coming to market,” said Collins. "This legislation would help promote competition in the pharmaceutical market and give American families access to more prescription choices at lower costs, and I’m thankful to Sens. Grassley, Klobuchar, and Reps. Nadler, Jeffries and Sensenbrenner for their partnership on this bill.”
“Too many Americans, particularly seniors, cannot afford their prescription drugs,” said Welch. “These petitions are intended for citizens to voice their personal concerns about new drugs coming onto the market, not for pharmaceutical companies to quash their competition. It is time to stop this blatant and anti-competitive abuse of citizen petitions by drug companies. Our bill does just that.”
“Bad actors abusing the FDA’s citizen petition process cause two-fold harm. Their delay tactics allow prices to remain exorbitantly high and keeping competition out of the marketplace. They also waste taxpayer money by forcing the FDA to spend time and resources separating the legitimate claims from the multitude of sham petitions,” Sensenbrenner said. “I’m encouraged that this Congress has made finding solutions to our rising drug prices a bipartisan priority and am proud to sponsor this important legislation.”
Specifically, the Stop STALLING Act would:
Create an FTC cause of action against sham petitions as unfair methods of competition,
Create a rebuttal 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.