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GPhA Applauds Governors' Citizen Petition on Generic Biopharmaceuticals

Posted on: Thursday, 3 August 2006, 12:01 CDT

ARLINGTON, Va., Aug. 3 /PRNewswire/ -- 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. For more information about the industry, visit http://www.gphaonline.org/.

The Generic Pharmaceutical Association

CONTACT: Andrea Hofelich, +1-703-647-2495

Web site: http://www.gphaonline.org/

Source: PRNewswire

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