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Association of American Physicians and Surgeons, Inc.
A Voice for Private Physicians Since 1943
Omnia pro aegroto

October 21, 2002

For immediate release:

Kathryn Serkes

Andrew Schlafly, Esq
[email protected]

More FDA Reforms Needed

The Association of American Physicians and Surgeons (AAPS) applauds President Bushís proposal to bring generic drugs to market faster announced today.

The new regulations proposed by the President reflect AAPSís argument in Eldred v. Ashcroft against patent and copyright extensions heard by the Supreme Court on October 9, 2002 (brief posted at www.aapsonline.org). The Presidentís plan would limit the ability of drug companies to prolong patent protections on brand name drugs.

"These serial drug patent extensions are highway robbery," said AAPS general counsel Andrew Schlafly. "Market competition, without extended patents, will bring seniors lower costs for drugs than any legislative scheme."

The Executive Director of AAPS emphasized that AAPS does not support generics over brand name drugs. "Generics are not right for everyone in every case. But patients should have the choice sooner rather than later," said Jane M. Orient, MD, an internist in Tucson, Arizona.

Dr. Orient also pointed out that many of the FDAís regulations add to the cost of prescription drugs and delay availability of generics as well as brand names. For example, last week a federal court sided with AAPS and overturned FDA regulations that required pediatric trials of most drugs before approval, including off-label uses and those intended only for adults, such as for Alzheimerís (statement and court decision posted at www.aapsonline.org).

"If Congress wants to get serious about drug policy, it should stop playing politics with competing prescription drug bills and follow the Presidentís lead. Clean up the agency and dump the regulations that stand in the way," said Dr. Orient.

AAPS is a non-partisan, due-supported professional association dedicated since 1943 to protection of the sanctity of the patient-physician relationship from third-party intrusion.

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