Published Online: Friday, June 1, 2007

A bipartisan group of governors is putting pressure on Congress to authorize the FDA to establish ?an efficient and effective abbreviated pathway for approval of generic versions of biophar-maceuticals.? In their letter to Congress, the governors argued that ?competition from generic drugs is already saving billions of health care dollars each year, but?generics and the savings they provide are not available for medicines approved as biopharmaceuticals??expensive medications that can cost patients as much as $200,000 annually.

There is ?little hope that Americans will have the benefit of generic versions of other biopharmaceuticals until Congress passes legislation authorizing the FDA to create an efficient and effective abbreviated pathway for approval of generic versions of biopharmaceuticals,? the governors said.

The involvement of 18 governors from Vermont to Oregon drew cheers from officials at the Generic Pharmaceutical Association (GPhA). ?Our nation?s governors understand all too well that the high costs of biopharmaceuticals are keeping needed medicines out of the hands of Americans,? said GPhA President and Chief Executive Officer Kathleen Jaeger.

Latest Articles
This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
Chronic kidney disease incidence has grown faster than many of its common comorbidities such as diabetes and hypertension, and medications may be an underappreciated driver of this growth.
President Barack Obama’s fiscal year 2017 budget proposal calls for an additional $1.1 billion to combat the nation’s spiraling opioid epidemic.
Baxter International is voluntarily recalling intravenous solution due to leaking containers and the potential for particulate matter.
Latest Issues