FDA: Drug makers obeying regulatory rules

WASHINGTON, Sept. 3 (UPI) -- The U.S. Food and Drug Administration says it has determined most producers of drugs and biologics are generally meeting their regulatory obligations.

The federal agency said a review of 1,531 post-marketing studies indicates more than 80 percent of the studies are proceeding according to the established timelines, have been submitted for review, or have been determined to have met their goals or are no longer needed, the FDA said.

The study, conducted under a contract with the consulting firm Booz Allen Hamilton, recommended changes designed to improve the quality of the information submitted to the FDA, the timeliness of the FDA review and the accuracy of the FDA's databases. The agency said it was evaluating the recommendations and already has made significant improvements based upon the study.

"New resources and directives from Congress have allowed us to complete this long-desired review," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "The data indicate that makers of approved drugs and biologics are generally meeting their regulatory obligations and are on track with their studies. To date, we have not identified any previously unknown serious safety issues from the submitted final study reports."