STOP GAMES Act Targeting FDA Citizen Petitions Draws Sharp Criticism from Former FDA Official

U.S. Representative Eric Sorensen (D-Illinois) has reintroduced the bipartisan STOP GAMES Act, legislation designed to lower prescription drug costs by targeting what he describes as "sham" citizen petitions filed by brand-name drug manufacturers to slow FDA approval of competing generic drugs. The measure would give the Food and Drug Administration greater authority to reject petitions it determines are primarily intended to delay market entry of new drugs.

"Nobody should have to choose between filling their prescription and paying rent," Sorensen said in announcing the bill.

The legislation would amend federal law governing FDA petition reviews and clarify the standards the agency can use when determining whether a petition's primary purpose is to delay approval of a drug application. Originally introduced in 2023, the bill has been reintroduced in the current Congress.

Former FDA Official Challenges Bill's Premise

Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest (搜索)搜索该词条, has emerged as a prominent critic of the proposal, arguing it mischaracterizes the purpose of citizen petitions and could create unintended consequences for drug development.

"Citizens' petitions were not designed to be used as tools for corporate strategy," Pitts told The Center Square. "They were designed to raise important issues to the FDA that the agency otherwise might not be thinking about."

Pitts acknowledged that some companies may use the process for business purposes but argued that does not justify weakening a regulatory tool that allows outside parties to raise safety and scientific concerns. "You don't want to reward bad behavior, but you certainly don't want to throw the baby out with the bathwater either," he said.

Disputing the Link Between Petitions and Generic Delays

The bill's supporters argue some pharmaceutical companies exploit citizen petitions to delay generic competition, with Sorensen stating such petitions are often filed late in the approval process and can keep lower-cost alternatives off the market.

Pitts directly disputed that characterization. "There has never been one citizen's petition that has resulted in the delay of a generic drug to market," Pitts said. "That's what lawsuits do."

He suggested that broader reforms to pharmaceutical law may be worth discussing but maintained that citizen petitions are not the source of delays lawmakers are targeting. "Is it time to reopen Hatch-Waxman and update it to the present realities of health care in the U.S.? I think the answer is yes," Pitts said. "But that does not make FDA's citizen petition anything other than what it is, which is a piece of paper with words on it that suggests the FDA is thinking about doing something."

Economic Rationale Under Scrutiny

Pitts also challenged the bill's underlying economic rationale, noting that generic drugs account for roughly 90% of prescriptions dispensed in the United States. "The underlying philosophy of the legislation is ignorant of the actual reality of drug pricing in the U.S.," he said.

According to Pitts, policies that reduce incentives for pharmaceutical companies to invest in high-risk research could ultimately harm patients by reducing the number of new treatments brought to market. "Bringing a new drug to market is an extraordinarily high-risk and expensive proposition," Pitts said. "Any legislation that doesn't recognize the inherent risk of drug development is thinking that is going in the wrong direction."

He warned that reducing opportunities for companies to recoup research investments could discourage future innovation. "If you take away the incentives for investing in developing drugs for serious and life-threatening diseases, you're going to get fewer new drugs in development," Pitts said. "This is a piece of legislation that is trying to punish investment in drug development."

Balancing Access and Innovation

Pitts emphasized that policymakers should pursue reforms that increase access to generic medicines without undermining incentives for developing new therapies. "Obviously, we want to facilitate generic drugs to market," he said. "But that should not mean deterring the incentives to invest in high-risk development for new drugs."

Asked about the bill's prospects, Pitts expressed strong skepticism, likening its likelihood of passage to "about as likely as my becoming the starting guard on the New York Knicks in the finals."