Rep. Hakeem Jeffries, D-N.Y. Associated Press / Jacquelyn Martin
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By Nelson A. King
Brooklyn Congressman
Hakeem Jeffries, chairman of
the House Democratic Caucus,
on Monday joined congressional
representatives in introducing
new bipartisan, bicameral
legislation to curb the abuse of
the Food and Drug Administration
(FDA) petition process and
increase access to affordable
prescription drugs.
Jeffries was joined by US Senator
Amy Klobuchar (D-MN),
Ranking Member of the Senate
Judiciary Subcommittee on
Antitrust, Competition Policy
and Consumer Rights; Senator
Chuck Grassley (R-IA), chairman
of the Senate Finance
Committee; 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).
Jeffries, who represents the
8th Congressional District,
which encompasses parts of
Brooklyn and Queens, said the
Stop Significant and Timewasting
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.”
He said the bill would also
give the Federal Trade Commission
(FTC) enhanced authority
to take action against those
who file sham petitions.
“No one should be forced to
make the unthinkable choice
between lifesaving prescription
drugs and putting food on
the table,” Jeffries said. “The
Stop STALLING Act aims to
drive down the sky-high cost of
medicine by expediting access
to affordable generic drugs for
everyday Americans.
“Senators Klobuchar and
Grassley, along with Representatives
Sensenbrenner, Collins
and Welch should be commended
for their leadership in
this regard,” he added.
Klobuchar 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,”
she said. “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.”
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,
Jeffries said 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.
Jeffries introduces bipartisan legislation
on affordable prescription medication