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FDA Works To Put Old Struggles Behind It

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FDA Works To Put Old Struggles Behind It

Health

FDA Works To Put Old Struggles Behind It

FDA Works To Put Old Struggles Behind It

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The last decade was a tough one for the Food and Drug Administration. The agency has been struggling. In part, because the drugs and devices it regulates got more sophisticated, food importers began bringing in products from places the agency had never been and Congress gave the FDA more duties. The FDA has a fresh outlook, thanks to more money and new leadership.

MADELEINE BRAND, host:

The Food and Drug Administration says it's getting tougher on companies who sell tainted food and drugs. The past decade was a difficult one for the agency. The drugs it regulates now are more sophisticated. Food importers bring in products from places all over the world now, and Congress wants the FDA to do more.

Well, with new money and new leadership, the FDA says it's ready to adapt. NPR's Joanne Silberner reports.

JOANNE SILBERNER: One of the lowest moments for the FDA in recent years came in 2008 at a hearing of a congressional committee. Democratic Representative John Dingell grilled then-FDA Chief Andrew von Eschenbach about not inspecting foreign drug manufacturing plants and the failure to prevent outbreaks of food-borne illnesses. There was plenty of desk pounding.

Representative JOHN DINGELL (Democrat, Michigan): This committee wants you to have the resources that you need to do the job that you have to do to protect the American people. Sixty-two people died because of bad effort. Hundreds of others were made sick.

SILBERNER: The FDA inspected just one-fifth the number of food manufacturing facilities in 2000 as it did in 1980. Von Eschenbach tried to say that using modern technology, the agency could inspect more efficiently, but Dingell broke in.

Rep. DINGELL: I didn't fall off the cabbage wagon yesterday, sir. I've been talking to Food and Drug commissioners for 40 years, and you're not the first fellow that I've had to skin for not doing his job and coming up here and defending an indefensible situation.

SILBERNER: Dingell and others accused the agency of playing politics with an over-the-counter morning-after pill to prevent pregnancy. And FDA was taken to task time and again for failing to deal promptly with problems with popular drugs like Vioxx.

New challenges cropped up - bioterrorism, complicated biotech drugs, increasingly sophisticated medical devices, and then food safety.

Caroline Smith DeWaal is with the consumer group Center for Science in the Public Interest.

Ms. CAROLINE SMITH DEWAAL (Center for Science in the Public Interest): In 2000, we were just becoming aware of the major role that produce played in causing food-borne illness outbreaks on a national level.

SILBERNER: And she says the agency was unequipped or unwilling to deal with it.

Ms. SMITH DEWAAL: You couldn't ask for more resources unless it was the policy of the administration that you were going to get more resources, and that wasn't the policy of the Bush administration.

SILBERNER: Food safety issues brought the financial crisis to a head - spinach, peppers, peanut butter, even dog food from China. So last spring the new administration brought in Margaret Hamburg, a former New York City health department commissioner, and the president promised to give her the tools to do her job. She's got a bigger staff on hand than her immediate predecessors, though it's still only at 1994 levels.

The FDA has faced less criticism from the pharmaceutical industry in recent years. Alan Goldhammer of the drug industry trade group says as for the long delays for drug approvals back in the 1980s...

Mr. ALAN GOLDHAMMER: We think at long last the financial support of the agency is level enough for the drug review program.

SILBERNER: In no small part because since 1992 the industry has been providing some of the funding for the reviews. His one concern: he says there appears to be interagency squabbles delaying some approvals. On the other side, Sid Wolf of the consumer advocacy organization Health Research Group says the drug approval process is still too industry friendly and that the agency needs to get tougher on prescription drugs already on the market.

FDA commissioner Hamburg is optimistic that she can make the drug review process safe and quick. She says she won't be shy about asking for more money for agency activities. She thinks she can bring the agency back.

Ms. MARGARET HAMBURG (Commissioner, Food and Drug Administration): We have gotten some additional resources in some key areas, and we're hoping that that trend will continue. We're also working with Congress in the hopes of getting new authorities in some key areas.

SILBERNER: Including widely supported food safety legislation that would bring in money from food processors for inspections and give the agency the power to assess fines.

The FDA has already set up offices in China and India, and it's got a lot more on its plate for the next few years. It just got the power to regulate tobacco; it just started monitoring drug information on the Internet. It's likely to be tasked with evaluating generic versions of biotech drugs. And through all this, Hamburg has promised to make the agency's inner workings more transparent.

Joanne Silberner, NPR News.

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