Summit News

FDA head to speed reviews, visit China

NEW YORK (Reuters) - The U.S. Food and Drug Administration is working to increase the speed of drug reviews and clean up problems in the division that oversees medical devices, the agency’s commissioner said on Thursday.

Food and Drug Administration Commissioner Dr. Margaret Hamburg speaks at the Reuters Health Summit in New York, November 12, 2009. REUTERS/Brendan McDermid

Dr. Margaret Hamburg, speaking at the Reuters Health Summit in New York, also said visiting China to discuss the safety of imported products was a top priority for her in 2010.

Hamburg in May took over an agency battered in recent years by a string of deadly food poisoning and drug safety issues. At the same time, companies complained the FDA had become too cautious and missed several drug review deadlines.

“We are certainly working hard in terms of speeding up time frames” for drug reviews while assuring safety, said Hamburg, a Harvard-trained physician with experience on issues ranging from infectious disease to biological threats.

She said the FDA was adding more staff and working to “leverage science to really improve the pathway to make it both more effective and efficient.”

Missing target dates for drug approval decisions is “a concern that we are trying to address,” Hamburg added.

Hamburg has pledged to restore confidence in the FDA, which oversees prescription and over-the-counter drugs, medical devices, most foods and other products that account for about one quarter of the U.S. economy.

She said the agency’s device unit was “clearly troubled” and it became immediately obvious to her that big changes were in order.

“We are working on some important issues that will benefit industry and benefit the ultimate outcome of our regulatory procedures, including making sure we have a robust internal review process,” she said.

An internal review of the 510(K) process, an abbreviated pathway used for some medical devices, is under way in addition to a study by the Institute of Medicine, Hamburg said.

On China, the FDA has grappled with tainted pet food, contaminated ingredients in the blood thinner heparin and other problems with products imported into the United States. Hamburg said she planned to visit the country next year to participate in ongoing discussions with officials there.

Assuring the safety of imported products will involve “expansion of our international inspection capacity as well as working with regulatory authorities in those countries to ensure compliance with a certain level of standards,” she said.

An FDA deputy commissioner has visited China twice in recent weeks, she said, adding that challenges exist in India and other countries.

“Moving into a globalized framework is going to be one of the greatest demands on my schedule and on the agency” she said.

Hamburg also said she hoped for a “long and healthy” tenure as FDA commissioner. Industry groups have complained about high turnover in the FDA’s top post in the past.

“I didn’t take on this job thinking it was going to be a short-term undertaking,” she said.

Reporting by Lisa Richwine and Susan Heavey; Editing by Phil Berlowitz, Matthew Lewis