FDA Modernization Act Gets President's OK

US President Bill Clinton signed into law the Food and DrugAdministration Modernization Act of 1997 (details of which appeared in Marketletter November 24) at a White House ceremony on November 21. The legislation received widespread support and passed Congress on November 9 with overwhelming bipartisan backing.

At the ceremony, Mr Clinton said the FDA is the "gold standard" for protecting the public interest and that this legislation should be awarded a "gold medal." The legislation is important because it maintains and redefines public interest at a time when there are new challenges in food safety and when there are new possibilities in medicine and medical devices, the President said.

The new law lets the FDA continue working with the medical and business communities to get new drugs and devices approved far earlier than before, he noted, and it offers hope to many critically-ill Americans by extending access to drugs and devices whose approval is still pending. For many people, he added, experimental treatment represents the best and perhaps the only chance of recovery.