Sorensen drug-pricing bill draws criticism from former FDA official

By Catrina Barker | The Center Square contributor
The Center Square

(The Center Square) – U.S. Rep. Eric Sorensen, D-Illinois, is backing legislation he says would lower prescription drug costs by targeting the use of Food and Drug Administration citizen petitions that can delay generic drug competition. But critics argue the proposal could undermine an important regulatory process and discourage investment in new medicines.

Sorensen recently reintroduced the bipartisan STOP GAMES Act, legislation aimed at preventing 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 FDA 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 congressman said pharmaceutical companies use the petition process to block lower-cost alternatives and keep drug prices high. The legislation would allow the FDA to reject petitions it finds are designed to delay competition rather than raise legitimate concerns.

Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest, said the proposal 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 said 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.

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

Pitts disputed that characterization, arguing citizen petitions themselves do not prevent generic drugs from reaching consumers.

“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 said 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.”

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.”

Pitts said 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.”

The STOP GAMES Act was originally introduced in 2023 and has been reintroduced in the current Congress. 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.

Asked about the bill’s prospects, Pitts said its chances of becoming law are extremely slim, likening its likelihood of passage to “about as likely as my becoming the starting guard on the New York Knicks in the finals.”