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Give FDA Resources to Make Food, Drugs Safe

You don’t have to go back many years in American history to find a nation in which most families — mine included — personally raised most of what they ate. My grandparents and great-grandparents lived on farms in Central Texas. They raised their own cattle, chickens and pigs, and they cultivated big truck gardens. I can remember in the early 1950s that if we wanted green beans and corn for dinner, I was sent out to pick them.

Now nearly all Americans depend on a vast network of producers, processors and distributors, and you and I get dinner from a store instead of a field. When it came from out back, nobody worried much about food safety, but that has changed with the times. Last year, 5,000 Americans reportedly died because they consumed contaminated food, mostly meat and seafood. Many of the deadly products were imported, and China was the source.

I’m working on a bipartisan basis to introduce legislation in the very near future that would update the Food, Drug and Cosmetic Act to authorize the Food and Drug Administration to extend its reach beyond our borders and discover any shenanigans perpetrated by foreign operators making food there, before the food gets here. The Bush administration supports this approach, as did the Clinton administration before it.

China’s reliably automated response is to construct a great wall of bureaucracy between our experts and their problem, but that’s not going to separate them from difficulty if they want to keep selling food to the world. Everybody who consumes that food has a right to know it’s safe, and that’s why other nations routinely cooperate with the United States, including giving FDA inspectors access to their manufacturing facilities.

The food we buy and eat can be as safe as if we grew it ourselves. On this issue, there’s no daylight between Republicans and Democrats. We have to work together to get this right, and we have to get it right sooner rather than later. The variety and the complexity of the products that are arriving on our shores increases every day. We have to take a new look at this and we have to do it in this Congress.

“Food” is FDA’s first name, but drugs are hardly less important. The work force of the agency began with a single chemist at the Civil War-era Agriculture Department, and it has grown to more than 10,000 today. The same year its predecessor agency was created by the 1906 Food and Drug Act, Collier’s weekly magazine put a skull on its cover and offered this warning:

“DEATH’S LABORATORY. Patent medicines are poisoning people throughout America to-day. Babies who cry are fed laudanum under the name of syrup. Women are led to injure themselves for life by reading in the papers about the meaning of backache. Young men and boys are robbed and contaminated by vicious criminals who lure them to their dens through seductive advertisements.”

You could get a dose of “Kickapoo Blood, Liver and Stomach Renovator” from a traveling show, and the Mugwump Manufacturing Co.’s “Specific Cure and Preventative for All Venereal Diseases” sold for only $1.50 a bottle. Modern medical marketing is more sophisticated, and the potential harm of tainted prescriptions is dramatically more troubling than all the patent medicines that were brewed over a campfire and sold off the back of a wagon.

Many Americans are surprised that so many drugs and their ingredients come from foreign places, but the truly worrisome surprise is that the FDA is struggling to ensure that these medicines won’t harm the people who take them. Doing the job takes knowledge, but the FDA does not even know how many Chinese firms sell us ingredients. When it tried to check up on Chinese-made ingredients of a blood thinner that killed several and sickened hundreds, the FDA famously discovered it had not inspected the factory beforehand because it had misread the maker’s name and OK’d output from the wrong plant.

Drug manufacturing went global over the past decade, but the FDA didn’t keep up. It continues with the same limited knowledge, the same strategy and the same second-class status for the foreign inspection program. Officials need more resources, but they also need fresh thinking and a new approach. I think FDA Commissioner Andrew von Eschenbach has a chance to be a hero by pulling his agency into the 21st century, and I’m ready to give him the support he requires to effectively detect and reject the tainted drugs that are arriving from abroad.

Finally, the FDA has to take a hard look at itself. A Republican staff inquiry recently disclosed that some of those the agency relies on for professional judgment in drug trials are committing fraud, and yet FDA cannot seem to muster them out.

The notorious example is Dr. Anne Kirkman-Campbell, an Alabama physician who participated in clinical trials of an antibiotic that produced liver failure after it was approved. Dr. Kirkman-Campbell’s data were audited and she eventually was prosecuted for mail fraud. She pleaded guilty in 2003 and is serving a sentence in federal prison. But that doesn’t mean FDA has banned her from taking part in drug tests.

The agency simply has failed to make its debarment authority work. Republican staff investigators uncovered cases where some felons were debarred while others were overlooked. No one seems to know why some were banned and others were not.

People aren’t the only problem. Current law requires FDA to debar offending companies, too, but only those that manufacture generic drugs. That is, drug companies are protected if the fraud relates to a name brand instead of a generic. It seems to me that lying is lying, and this wrinkle in the law purges some liars while accommodating others.

The problems at FDA are daunting and they are expanding, but I think that a little common sense and some modest legislating can ensure that no matter which side of the planet our food and medicine come from, American families will be safe.

Rep. Joe Barton (R-Texas) is ranking member on the Energy and Commerce Committee.

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