US FDA Modernization Compromise Viewed

US Health and Human Services Secretary Donna Shalala has applauded thebipartisan compromise reached on the Food and Drug Modernization Act of 1997 (Marketletter November 14). The new law codifies several FDA initiatives undertaken as part of Vice President Gore's Reinventing Government program and builds on recent agency progress in expediting access to important medical products, she said.

It will also allow the FDA to continue making meaningful progress in speeding up the review of critical drugs and medical devices, while upholding the high standards of the world's safest and most effective medical products, Ms Shalala added.

Pharmaceutical Research and Manufacturers of America president Alan Holmer told the New York Times that the bill would shave at least a year off the average 12-15 years that now elapses from a new drug's discovery to its arrival in the family medicine chest. It could set up new procedures to speed approval of drugs used for serious or life-threatening conditions, giving the FDA authority to use alternative measures of effectiveness, such as shrinkage of a tumor or reduction in the amount of virus in a patient's body, to indicate that the drug will produce clinical benefits.