FDA Goes, Hat in Hand, To the Drug Industry

Prescription pills"Regulators usually don't negotiate their budgets with the industries they oversee," writes Anna Wilde Mathews, but the U.S. Food and Drug Administration does. In the early 1990s, drug companies started paying the FDA millions of dollars in user fees, to speed the drug approval process. The fees "now fund more than half the agency's critical drug-review process." Industry groups and the FDA renegotiate the fees and how they're used every five years, giving drug makers "considerable input into which programs receive funding." The FDA is currently negotiating the next agreement, with the Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization. The industry groups are pushing for faster decisions on "labels and other conditions on approval" of new drugs, and faster review of ads voluntarily submitted to the agency. The FDA wants more funding to monitor drugs' safety following their approval.