FDA and drugmakers agree to extend user fee plan
WASHINGTON (AP) — The Food and Drug Administration has agreed to work toward faster, more predictable reviews of new prescription drugs in return for hundreds of millions of dollars in continuing fees from drug makers, under a draft agreement unveiled Thursday.
The deal comes after months of close-door meetings between FDA and drug industry officials to extend a two-decade-old program that supplements the agency's budget with company fees. The latest agreement would require the FDA to provide more frequent updates on the status of certain drug reviews.
Congress still must approve the deal. It already has granted three 5-year extensions to the program. Since it was enacted in 1992, the program has allowed the FDA to hire hundreds of additional scientists in return for meeting certain performance goals.