October 7, 2010

FDA Unveils Plan To Boost Regulatory Science

The U.S. Food and Drug administration plans to spend millions of dollars to update its tools for reviewing prescription drugs, medical devices and tracking food safety, according to a proposal released Wednesday by the agency's leadership.

The plan calls for investment in a variety of efforts, from developing ways to assess new products to establishing better tests to identify contaminants in food -- all aimed at keeping pace with rapid changes in science and technology.

"We need new approaches, new collaborations and new ways to take advantage of 21st century technologies," the FDA said in its white paper announcing the initiative.

The plan should ultimately "bolster" regulatory science and "creative approaches to product development and safety for both food and medical products."

The FDA currently oversees the safety of nearly 25 percent of all products sold in the U.S., including many foods, cosmetics, prescription medications and medical devices.

In a speech at the National Press Club in Washington, FDA Commissioner Margaret Hamburg said the agency will spend $25 million in the year ahead on collaborations with scientists from industry, academia and the government.

Improved scientific standards will accelerate the approval of critical new products, and will allow the agency to better identify potential safety problems, Hamburg said.

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

The FDA is seeking to collaborate on a number of efforts, including work to predict medication side effects based on the genetic profile of individual patients, to scale back or eliminate drug testing on animals, and to prevent the spread of bacteria in the food supply.

Modernization is a key focus for the FDA's leadership as the federal agency scrambles to keep pace with the scientific developments behind the latest drugs, devices and foods.

Federal funding of the FDA has typically fallen short of the agency's budget requests, triggering a series of user fee programs in which pharmaceutical companies and medical device makers must help fund the agency's reviews of their products.

The $25 million investment cited in the FDA proposal is part of the Obama administration's proposed $4 billion fiscal year 2011 budget.  

However, after failing to pass fiscal 2011 appropriations before returning home for the November 2 midterm elections, members of Congress recently passed a resolution to continue to fund federal agencies at 2010 levels.

Hamburg said Wednesday that given the FDA's mission to protect public health, funding the agency should be a priority regardless of which party controls Congress.

"There is no other agency in government that does what we do," said Hamburg, a former New York City health commissioner.

"If we can't do our job and do it well, there's no one there to backstop us," she told reporters.

But the recent recall of more than a 500 million eggs linked to salmonella has highlighted 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 proposal states.

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