FDA stresses need to modernize its science

[October 07, 2010]  WASHINGTON (AP) -- The Food and Drug Administration must update its scientific tools for reviewing prescription drugs, medical devices and tracking food safety, according to a research plan laid out Wednesday by agency leadership.

FDA Commissioner Margaret Hamburg said the agency will spend $25 million in the coming year on collaborations with outside scientists from academia, government and industry. In a speech at the National Press Club, Hamburg said that improved scientific standards will help speed up the approval of important new products and spot safety problems sooner.

"Regulatory science can deliver us better, more targeted therapies, more quickly," Hamburg said.

The FDA oversees the safety of nearly one-fourth of goods sold in the U.S., including many foods, prescription drugs, medical devices and cosmetics.

The federal agency is looking to collaborate on a host of projects, including efforts to predict the side effects of drugs based on the genetic code of individual patients, to reduce or eliminate drug testing on animals and to prevent the spread of salmonella and other bacteria in the food supply.

Modernization is a perennial theme for FDA leadership as the agency struggles to keep up with the evolving science behind the latest drugs, devices and even foods. Last month the agency held a three-day meeting on the safety of a genetically modified salmon that grows twice as fast as the naturally bred fish.

But federal funding for the agency traditionally has lagged behind the agency's budget requests, giving rise to a series of user fee programs in which drugmakers and medical device makers help pay for the agency's review of their products.

The $25 million investment cited by Hamburg is part of the administration's proposed $4 billion budget for fiscal year 2011, which began Oct. 1. But congressional lawmakers recently passed a resolution that will continue to fund agencies at 2010 levels, after failing to pass fiscal 2011 appropriations before returning home to campaign.

If Republicans regain control of the House in November, the FDA's Obama-appointed leadership could face an even tougher time securing funding increases for the agency.

But Hamburg said Wednesday the FDA's mission of protecting public health should make it a priority no matter which party controls Congress.

"There is no other agency in government that does what we do," Hamburg told reporters. "If we can't do our job and do it well, there's no one there to backstop us."

Hamburg, a former health commissioner for New York City, was nominated last year to bolster the agency's regulatory image after a string of food and drug safety scares under the previous administration. However, the recent recall of more than a half-billion eggs linked to salmonella has underscored the limits of the agency's powers.

"As in other areas, the effectiveness of FDA's food safety program depends on the strength and capacity of the science underlying it," the agency paper states.

In 2007, the agency's outside panel of science advisers said the FDA was in danger of failing in its mission because of a lack of scientific expertise.

[Associated Press; By MATTHEW PERRONE]

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