Friday, September 21, 2012

Keeping pace with globalization: A question of public health

One-quarter of every dollar spent in this country goes to products regulated by the U.S. Food and Drug Administration (FDA). Think about that for a minute. Every meal you eat, every medicine you take, every cosmetic you use, even the food you feed your pet was vetted for safety by FDA experts. But in an increasingly globalized world, the agency’s responsibilities are quickly outpacing its resources.

In addition to all the food, drugs, biologics, medical devices, cosmetics, dietary supplements, and veterinary products made in the United States, FDA also regulates products coming into the U.S. from more than 300,000 facilities in 150 countries around the world.

However, we could be heading toward some risky compromises– and fast. Consider this:
  • 80 percent of the active pharmaceutical ingredients in medications sold in the U.S. are manufactured elsewhere.
  • Nearly two-thirds of the fruits and vegetables consumed domestically come from outside of this country.
  • Half of all medical devices used in the U.S. are imported.
  • Food and medical device imports are growing by an average of 10 percent per year, and pharmaceutical product imports are increasing by nearly 13 percent per year.

“While foreign manufacturing facilities have increased dramatically, FDA’s budget and staffing have remained consistent,” noted Marcie McClintic Coates of Mylan, one of the largest generics and specialty pharmaceutical companies in the world, at a Capitol Hill briefing that FasterCures Executive Director Margaret Anderson moderated earlier this week. “Because their resources for international inspections are so limited, FDA has not visited some of our facilities in more than nine years.”

Panelist Ron Guido of Johnson & Johnson pointed out that counterfeiting is the largest growing industry in the world and the crime of 21st century. “Up to 10 percent of the pharmaceuticals coming to the U.S. may be counterfeit. To put that into perspective, 1 percent equals 40 million prescriptions.”

The challenges of globalization are perhaps most visible in the food industry. “Food imports have almost doubled in the past 10 years,” said Caroline Smith DeWaal of the Center for Science in the Public Interest, “and FDA doesn’t have the capacity or inspection structure to keep up with the needs of consumers, which raises frightening possibilities.”

Congress has passed two new laws aimed at helping FDA handle its responsibilities: The Food and Safety Modernization Act and the Food and Drug Administration Safety and Innovation Act. But the agency is not yet receiving adequate funds to implement either law. And sequestration would further compromise FDA’s public health mission, making an already tenuous situation worse. 

For a resource-intensive agency that spends 80 percent of its budget on people (inspectors, researchers, etc.), cuts could have especially far-reaching effects, impacting the products we use every day and expect to be safe and effective. Even though the agency collaborates with foreign governments, “there is no inspection like an FDA inspection,” noted McClintic. “The bar is higher.”

For more information on strengthening the FDA, visit the Alliance for a Stronger FDA at:

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