JIM LEHRER: Now: to the Food and Drug Administration and to questions of regulation. The salmonella outbreak and the major egg recall have raised questions once again about whether an agency charged with regulating drugs and food can adequately do its job.
NewsHour health correspondent Betty Ann Bowser has our report. Our Health Unit is a partnership with the Robert Wood Johnson Foundation.
BETTY ANN BOWSER: For the past few years, it’s been one food safety scare after another. There was E. coli-laced spinach, salmonella-tainted peppers. Then peanut butter products were recalled, and the latest, bacteria-laden eggs.
There have also been problems with drugs. The ingredients in a contaminated blood thinner came from China. And whether the tainted products are from abroad or the United States, it’s the Food and Drug Administration’s job to make sure they’re safe for American consumption. The FDA has received some new money from Congress to police food and drugs, $141.9 million last fiscal year alone just for food safety, a top priority for FDA Commissioner Dr. Margaret Hamburg.
MARGARET HAMBURG, commissioner, Food and Drug Administration: We want to try to work with the food industry to put in place risk-based strategies and preventive controls to ensure that problems will not arise, rather than chasing them after the fact and waiting until people get sick to identify that there’s a problem, and then scramble to address it.
All of this will take time, of course, but it will make our program, I think, much more effective and efficient.
BETTY ANN BOWSER: But Hamburg says it’s not enough, because her agency needs more money and resources to do its job.
MARGARET HAMBURG: FDA plays this critical and unique role, and, yet, it’s mysterious to me. I really don’t understand, but we have never had the resources that we need to fully support our activities. We have, you know, unfortunately been under-resourced over many years in this important area, and at a time when, in fact, the global challenge is growing.
BETTY ANN BOWSER: Another challenge, tens of millions of packages filled with pharmaceuticals from other countries pour into the United States every year. Most are illegal, and not approved for use in this country, and some are well-disguised counterfeits.
Any of this stuff — this stuff dangerous?
ANDREA CHARLES-JULIEN, investigator, Food and Drug Administration: Oh, definitely, definitely, especially when you see a lot of the counterfeit medications.
BETTY ANN BOWSER: Andrea Charles-Julien is the FDA’s lead inspector in one of the busiest international mail-processing points in the country, Miami.
ANDREA CHARLES-JULIEN: We see a lot of the antibiotics, tetracycline, ampicillin. We see a lot of injectable contraceptive medications, heart medications. You name it, we see it.
BETTY ANN BOWSER: Many of the counterfeit drugs have the wrong ingredients, not enough ingredients, or are just outright fakes.
The products often come from online pharmacies. More and more Americans are buying medications online with or without a prescription because they don’t have health insurance or they can’t afford to get a prescription from a licensed physician.
A typical Viagra pill can cost $8, on the Internet, perhaps as little as 99 cents. We found some sites offering a two-for-one, free Viagra with the purchase of another medication, and without a prescription. While there have been very few reported cases of people becoming sick or dying from taking unapproved or counterfeit drugs, the FDA is concerned because the trade is growing so fast.
DAVID ELDER, director of Regional Operations, Food and Drug Administration: The volume of imports has been growing exponentially over the past decade. Our ability to regulate them is challenged. The amount of staff that we have has certainly not kept pace with the growth.
Now, this is an interesting one.
BETTY ANN BOWSER: David Elder heads the FDA’s field operations. He says Miami is a good illustration of the agency’s manpower shortage. Of the 36 million pieces of mail that come through here each year, 8,000 to 10,000 get pulled for inspection. But FDA employees, just three of them, are able to inspect only about 40 a day.
Eighty percent of all the ingredients in drugs sold in U.S. pharmacies today are imported. That includes prescription and nonprescription drugs. The largest quantities come from India, China, and Canada. And while these ingredients are produced in factories overseas that are approved by the FDA, they rarely get inspected by federal regulators.
Allan Coukell, a pharmacist and director of the medical safety program at the Pew Health Group, says, in the last decade, the number of plants in India and China making ingredients for the American market has doubled, at a time when FDA has fewer resources to inspect them.
ALLAN COUKELL, Pew Health Group: If you’re manufacturing overseas, you might never see an inspector after the initial inspection at the beginning of your manufacturing process.
When inspections do go on overseas, they tend to be much shorter than domestic inspections. They’re generally pre-announced, meaning the manufacturer has time to prepare. And, if problems are identified, the agency is much less able to go back subsequently and follow up to see whether those problems were adequately corrected.
BETTY ANN BOWSER: In 2008, 81 people died in the U.S. after being given the blood thinner heparin. Ingredients for its manufacture came from China. Heparin is made from pig intestines and some mom-and-pop operations like this one, shown on the Wall Street Journal’s Web site, where there is virtually no quality control.
ALLAN COUKELL: We know there are risks associated with making drugs this way. Someone in China deliberately sold a counterfeit ingredient into the manufacturing process. It looked to tests like the real ingredient, but it ended up sickening Americans here.
BETTY ANN BOWSER: A 2008 Government Accountability Office report said it would take FDA 13 years to inspect all of its approved drug facilities abroad, including 566 in China and 299 in India. Doctor Hamburg says, because drugs have become so much a part of the global economy, FDA needs Congress to update its resources and give it more legal authority.
MARGARET HAMBURG: You know, you have to — to realize that many of the laws that created the FDA are the same laws that we’re operating under today. And, at one time, they were fitting and appropriate, but the world has changed a lot. And we do need some new tools and authorities.
BETTY ANN BOWSER: Hamburg also wants Congress to give FDA more power to regulate the nation’s food supply, which every day comes more and more from other countries.
A bill that would have been the first to increase FDA’s authority over food in 70 years passed the House last year, but the Senate failed to take action before going home for its summer recess. The legislation would require many food processors to keep records and report what they do to prevent contamination, would give the agency power to recall food products suspected of contamination. Currently, FDA can only react when tainted food has made people sick.
Former Deputy FDA Commissioner William Hubbard says, the legislation is badly needed.
WILLIAM HUBBARD, former deputy commissioner, Food and Drug Administration: The Centers for Disease Control estimates that maybe 75 million people get sick each year from contaminated food, and maybe 3,000 or 4,000 of them will die, and 300,000 of them will end up in the hospital. That’s a lot of people. And the economic costs are very high. When I started in the FDA in the 1970s, the food budget was half of the agency’s budget. Today, it’s only a quarter. So, the food budget’s been allowed to deteriorate.
They only do about 8,000 inspections of domestic food processing facilities in this country now, and there are 150,000 of them to inspect. So, it doesn’t take a rocket scientist to figure out they’re not doing nearly as much as the public would expect them to do.
BETTY ANN BOWSER: Currently, FDA inspects only 1 percent of all imported food at the dock. Meanwhile, there are more than 150,000 foreign processing companies shipping their food products into the United States.