FDA official sees some delays over safety
By Lisa Richwine and Susan Heavey
SILVER SPRING, Maryland (Reuters) - A new focus on drug safety is delaying the approval of some medicines as regulators impose requirements meant to minimize side effects, a top U.S. drug regulator told Reuters on Tuesday.
The Food and Drug Administration gained new powers in March to require distribution limits or other restrictions on the sale of new medicines.
"That's taking a considerable amount of time more for every application. That will go away in time," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an interview with Reuters.
At present, the process is adding days or weeks to reviews of drugs that need the additional safety measures, she said.
Woodcock has worked at the FDA for more than two decades. In March, she returned to a previous post running the agency's drugs division after taking other leadership responsibilities.
She said one goal was to direct a "major cultural shift" to emphasize the safety of medicines. The FDA has been criticized in recent years for being slow to respond to problems with Merck & Co Inc's withdrawn arthritis pill Vioxx and other medicines.
"We have to change ... We have gotten that message loud and clear from the public," Woodcock said.
But, she added: "We are not losing our emphasis on drug development."
Woodcock also said the agency was concerned about the safety impact of the growing number of clinical trials being conducted outside the United States by drugmakers.