ARLINGTON, Va., Feb. 9 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today issued the following statement in response to Pfizer's February 8 press release. GPhA has not reviewed the citizen petition referred to in Pfizer's release and, as a general matter, does not comment on patent litigation matters. However, because the press release contained an unwarranted business practice, GPhA is compelled to respond.
"Our nation would be better served if Pfizer focused its resources on research and innovation, rather than unwarranted attacks on FDA's generic approval process and attempts to undermine America's confidence in generic medicines," said Kathleen Jaeger, GPhA President and CEO.
"It's disappointing to see a leader in the pharmaceutical industry such as Pfizer try to make this litigation issue about consumer confidence in affordable generics.
"They know, just as we know, that FDA-approved generics provide the same medicine and the same results as brands," said Jaeger. "For more than 20 years, America's generic pharmaceutical industry has been improving lives for less."
Generics represent 53% of the total prescriptions dispensed in the United States, but less than 12% of all dollars spent on prescription drugs. Pfizer's press release calls into question certain attributes of generic medicines, yet it has been FDA's long-standing policy that products containing the same active ingredient with different waters of hydration (i.e., molecules of water, such as monohydrate, dihydrate) are considered to be the same active ingredient and are deemed to be pharmaceutically equivalent (substitutable). See "FDA's Approved Drug Products With Therapeutic Equivalence Evaluations" (commonly referred to as the Orange Book) at XV (2005).
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. For more information about the industry, visit http://www.gphaonline.org.
GPhACONTACT: Andrea Hofelich of GPhA, +1-703-647-2495
Web site: http://www.gphaonline.org//
