Legislation creates public-private partnerships to improve the Food and Drug Administration drug approval process
WASHINGTON - U.S. Rep. Gabrielle Giffords has introduced legislation aimed at streamlining the lengthy drug development process.
The Safe and Effective Drug Development Act of 2007 will enable the Food and Drug Administration (FDA) to partner with universities and non-profit organizations in an effort to get potentially life-saving drugs to consumers faster and more safely.
“This is common sense legislation that is long overdue,” the Tucson lawmaker said. “My bill will create public-private partnerships that will improve the testing process so that drugs can move through the development and approval process more efficiently. Consumers will benefit by having access to more reliable and less costly medications.”
Giffords’ bill has bi-partisan support and is receiving praise from health care professionals such as Dr. Raymond Woosley, the president and CEO of The Critical Path Institute (C-Path) in Tucson, Arizona. Woosley, a former vice president at the University of Arizona’s Health Sciences Center, called the bill, “a positive move toward preventing the approval of medications like Avandia,” the widely-used diabetes drug whose safety has recently come into question.
“We have a major problem with pharmaceutical development in this country today,” Woosley said. “I compliment Congresswoman Giffords for introducing a bill that really gets at the crux of this problem.”
Over the past decade, U.S. pharmaceutical research and development spending has soared 250 percent and the budget for biomedical research at the National Institutes of Health has doubled. Yet over the same period the number of new drugs submitted to the FDA for approval has declined by almost 50 percent. In addition, some drugs have been approved that were subsequently discovered to be dangerous.
Part of the reason can be attributed to outmoded testing practices in the pharmaceutical industry and absence of a mechanism for manufacturers and the FDA to agree upon improved testing methods.
“Innovation and collaboration is needed,” commented Giffords. “Both private industry and the federal government are spending more money on research, but we are not getting the results we need - safe, life-saving and less costly medications for Americans.”
In response to this situation, the FDA in 2004 began an initiative to partner with universities and non-profit organizations throughout the country to address specific problems confronting the drug development and approval processes. Giffords’ bill authorizes and expands this successful initiative.
The full text of Giffords’ bill, H.R. 2592, can be found by clicking on the “Issues and Legislation” icon at http://giffords.house.gov/ or contacting the congresswoman’s office.