New law expands FDA monitoring, funds

The multifaceted measure covers drug safety -- including stepped-up monitoring of drugs on the market -- children's special needs and food safety.

By Susan J. Landers, AMNews staff. Oct. 22/29, 2007.

Washington -- Long-awaited resources to help the Food and Drug Administration more closely monitor the safety and effectiveness of the nation's pharmaceuticals and medical devices will begin to flow as a result of a comprehensive new law signed Sept. 27 by President Bush.

The Food and Drug Administration Amendments Act of 2007 reauthorizes the Prescription Drug User Fee Act, the Medical Device User Fee Act and laws that govern the safety of children's drugs and devices.

It also includes new measures that require the monitoring of massive databases to detect safety problems early, expand clinical trial registries and add a new public-private foundation dedicated to drug development.

The law was given "must-pass" status by Congress because without it, an important FDA funding source -- PDUFA -- was set to dry up at the end of September.

Congress also stepped in to help the beleaguered agency shore up its sagging reputation as the nation's pharmaceutical watchdog. Recent high-profile drug withdrawals had shaken public confidence in the FDA's abilities.

Sen. Mike Enzi (R, Wyo.), a bill sponsor and ranking member of the Senate Health, Education, Labor and Pensions Committee, praised the way the House and Senate worked together to gain the measure's final approval. But yet, "Is it a perfect bill?" he asked. "That never happens around here. Is it a big victory for patients and children? Yes it is."