FDA official sees some delays over safety

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. health official 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.

"It's not a huge delay," she said, adding the process should quicken once the agency gains more experience.

Managers have been given discretion to miss some drug approval dates if needed, she said. "We have a huge to-do list. It was clear we weren't going to get everything done," she said, also noting a backlog of unfilled staff positions.

A hiring effort now underway should help ease the workload, she added.

Drug decision dates, which generally come six or 10 months after a drugmaker files an application, are considered goals and not solid deadlines.

Some industry analysts predicted Woodcock's return to lead the FDA's drug division would help spur drug approvals after what some saw as a slowdown following Merck & Co Inc's 2004 withdrawal of arthritis pill Vioxx.

Woodcock, who has worked at the FDA for more than two decades, held various senior roles before returning to her previous post running the agency's drugs division in March.

She said one goal was to direct a "major cultural shift" to emphasize the safety of medicines. The FDA has been criticized as being slow to respond to problems with medicines such as Vioxx, which Merck withdrew after research found it doubled heart attack and stroke risk.

Congress responded last year with a law that boosted the FDA's authority over drugmakers in an effort to improve safety oversight.

"We have to change ... We have gotten that message loud and clear from the public," Woodcock said.

"The safety issues are not being permitted to slip down below other deadlines. They are given very high priority," she added.

The FDA is improving its tracking of safety concerns with the thousands of drugs on the market and setting clear timelines for dealing with them, she said.

"What we are going to do is put the same type of focus on the post-market realm as we are in the pre-market, in terms of accountability, timelines, project management and so forth," Woodcock said.

But, she added: "We are not losing our emphasis on drug development."

"We understand that for people with unmet medical needs, drug development is the pathway that brings them hope, so we need to keep that strong," she said.

'THORNY' TRIAL ISSUES

While the agency is focusing on the safety of products already on the market, Woodcock said there is growing concern about the increasing number of clinical trials being conducted outside the United States.

FDA inspectors visit research sites to ensure proper records and data collection. But with more drugmakers moving trials to China, Eastern Europe and other regions, "it's much harder for us to get there," Woodcock said.

"It's very thorny as to how we're going to manage," she said.

The agency already faces a budgetary squeeze in the face of other safety demands. U.S. lawmakers are considering providing additional funds for manufacturing inspections in other countries but have so far not targeted clinical trial inspections.

"We have to recognize that these are changes that are happening outside in the world and that the regulatory program has to evolve and change to cope," she added.

(Reporting by Lisa Richwine and Susan Heavey; editing by Gerald E. McCormick and Carol Bishopric)