Sorensen drug-pricing bill draws criticism from former FDA official
[June 08, 2026]
By Catrina Barker | The Center Square contributor
(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.
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Photo: Alan Wooten / The Center Square
"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.”
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