As Democrats prepare to take control
of key House and Senate committees,
Generic Pharmaceutical Association
(GPhA) President and Chief Executive
Officer Kathleen Jaeger expressed optimism
that the fresh start on Capitol Hill
will translate into progress on the industry's
key legislative priorities.
"When the new Congress convenes in
January, it will have a real opportunity to
improve the health care of Americans by
increasing access to safe, effective, and
affordable generic medicines," said
Jaeger. Topping GPhA's legislative wish
list: creation of an abbreviated approval
pathway for biogenerics.
"The FDA should exercise its responsibility
to create and not keep consumers
waiting for affordable medicines," she
said in a speech to health care leaders in
Washington. "If the FDA can review the
more expensive medicines, they should
also work on behalf of consumers and
review generic alternatives."
Jaeger specifically called on Congress
to enact the Access to Life-Saving
Medicine Act, legislation introduced in
the House by Rep Henry Waxman (D,
Calif), and sponsored in the Senate by
NY Democrats Charles Schumer and
Hillary Clinton. That bill would help "to
bring lifesaving biogenerics to consumers,"
she said.
Jaeger also stressed the need for
Congress to
remove other
barriers to
the marketing
of costsaving
generic drugs, including the use
of such tactics as authorized generics
and citizen petitions by branded manufacturers
to delay generic competition.
Additionally, the GPhA chief urged the
new Congress to reauthorize legislation
important to the generic drug industry,
including the Prescription Drug User
Fee Act, the Pediatric Research Equity
Act, and the Best Pharmaceuticals for
Children Act.