The Generic Pharmaceutical Association (GPhA) today
applauded Governors Kathleen Sebelius (D-Kan.),
Tim Pawlenty (R-Minn.), James H. Douglas (R-Vt.)
and Jim Doyle (D-Wis.) for
filing a citizen petition with the U.S. Food and Drug Administration (FDA)
seeking immediate release of agency guidance that would pave the way for
introduction of more affordable, generic versions of Insulin and Human
Growth Hormone (HGH). The citizen petition was filed earlier today.

"The Governors have correctly noted that biopharmaceutical products
place an extreme burden on state healthcare budgets, one that could
significantly be lowered if an efficient and effective mechanism existed
for the development and approval of generic biopharmaceutical products,"
said Kathleen Jaeger, President and CEO of GPhA. "Both of these products
are older, simpler, well-understood and characterized biopharmaceuticals.
Yet, for more than seven years, the FDA has been unable to provide the
generic industry with regulatory guidance that would permit the
introduction of generic versions of these products. The time has come to
open the floodgates for generic competition on these and other products."
"While many citizen petitions are frivolous, and often used to
unnecessarily block generic competition, the Governors' petition represents
the way that this system should work. It creates a mechanism that will
require appropriate FDA consideration and response to an urgent consumer
need," Jaeger added. "FDA's paralysis is in stark contrast to the European
Medicines Agency (EMEA), which has taken enormous strides toward the
approval of generic biopharmaceuticals. The EMEA has published a series of
guidances that provide a roadmap for the approval of several different
types of generic biopharmaceuticals. U.S. consumers, as these Governors
outlined in the citizen petition filed today, should not be left behind."
The largest obstacle to enhanced consumer savings through timely
generic market entry is the lack of an efficient and effective approval
pathway for generic biopharmaceuticals, sometimes referred to as
biogenerics. According to IMS Health, biologic drug product sales jumped
17.2% in 2005, to $32.8 billion. An efficient and effective approval
pathway would allow generic companies to develop and market less-expensive
versions of these drugs. In turn, patients and taxpayers would save
billions of dollars on biologic products alone.
According to the citizen petition, American patients spend
approximately $1.5 billion on insulin products to treat diabetes and
approximately $433 million on HGH, which is used to treat a variety of
conditions, including growth deficiencies in children and adults, chronic
renal insufficiency, and AIDS wasting syndrome. Market competition for
insulin and increased market competition for HGH products could save the
American health care system hundreds of millions of dollars annually.
"It is our position that the 505(b)2 FDCA approval process, in
conjunction with FDA's authority under the Public Health Act (PHS), already
serves as a foundation for the approval of safe and effective generic
biopharmaceuticals," Jaeger concluded. "We will continue to call on
Congress to codify FDA's authority to approve generic biopharmaceuticals
under section 351 of PHS."
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. Generics represent 56% of the total prescriptions
dispensed in the United States, but less than 13.1% of all dollars spent on
prescription drugs.