Generic Pharmaceutical Association (GPhA) President and
CEO Kathleen Jaeger yesterday released the following statement regarding
legislation crafted by Senators Edward Kennedy, Michael Enzi, Hillary
Clinton, and Orrin Hatch that would authorize the Food and Drug
Administration to approve biogenerics:
"GPhA applauds the bipartisan efforts of Members of the Senate Health,
Education, Labor and Pensions Committee to facilitate the ultimate
passage of 'The Biologics Price Competition and Innovation Act of 2007.'
However, we continue to have significant concerns about two specific
provisions of the Manager's Amendment that would unnecessarily delay
getting safe, effective, more affordable biogenerics into the hands of
"First, we continue to oppose the extension of 12 years of market
exclusivity that this legislation grants brand biotechnology companies.
Such an arbitrary and excessive period of time is not only unprecedented
and unwarranted, but more importantly, would unjustifiably delay access
to affordable competition and choice for consumers and businesses alike.
"Second, we believe another flawed provision would permit brand
companies to make a minor change to their product and receive an
additional 12 years of exclusivity. This provision could allow brand
companies to make multiple minor changes to their products and receive
12 years for each change, in effect maintaining their monopolies in
perpetuity. This practice, commonly known as 'evergreening,' would
essentially prevent safe and affordable life saving biogenerics from
ever reaching patients. We have been informed by Senate staff that this
is not the true intent of the compromise agreement forged by the Senate
and will work with the negotiators to craft language that addresses this
"Once again, we commend the extraordinary efforts of the Committee to
craft a long-overdue pathway for safe and effective biogenerics.
However, we must underscore that changes to the underlying bill must be
made in order to ensure that this bill achieves the very real potential
of this legislation and ultimately gains our support. None of us want to
participate in a process that produces little more than an empty
promise. We are confident that working together in good faith with all
stakeholders-consumers, businesses, health plans, Governors, and
representatives of the pharmaceutical industry-the Congress can and will
produce a workable legal and regulatory pathway for biogenerics."
GPhA represents the manufacturers and distributors of finished generic
pharmaceuticals, manufacturers and distributors of bulk active
pharmaceutical chemicals, and suppliers of other goods and services to
the generic drug industry. Unbranded and branded generics represent 63%
of the total prescriptions dispensed in the United States, but only 20%
of all dollars spent on prescription drugs.
Publication Date: 2007-06-29 03:00