The Food and Drug Administration (FDA) is defending itself against charges that the agency's drug approval process was too fast and counter charges that the agency has slowed the process too much. The head of the FDA's drug division, Dr. Janet Woodcock, defends the agency; she says that approval time increased by an acceptable four months last year.

Several drugs waiting years for approval finally got the green light in 2000, causing the increase in approval time. In addition, Woodcock is challenging the pharmaceutical industry to develop novel drugs. In recent years, the majority of drugs submitted for approval have been medications similar to ones already approved. According to the agency, few breakthrough medications have been introduced.

The drug industry's main trade association claims that overall approval time has not changed substantially. In 2000, drug approval took approximately 15.6 months, an increase from 1999's 11.6 months.

Investment research companies monitoring approvals found some evidence indicating that the FDA is aggressively investigating drug safety. For example, the FDA recently rejected Zelnorm, an experimental Irritable Bowel Syndrome treatment, citing safety concerns. At the same time however, the FDA approved a breakthrough leukemia drug, Gleevec, in a record three months.

Researchers say that FDA approval of biotechnology drugs seems to take longer than with conventional pharmaceuticals. This may be a result of companies submitting approval applications before they have completed required studies and tests.