Many of the safety and effectiveness studies the Food and Drug Administration orders as a condition of approval are behind schedule or overdue, according to federal records reviewed by The Washington Post in a report published Thursday. The studies at issue were required by the agency itself, not volunteered by industry.
The arrangement is deliberate. To get treatments to patients faster, the FDA allows companies to answer some remaining questions about a product after it is already on pharmacy shelves and in operating rooms. The unfinished-study problem is what happens when that second half of the bargain slips.
