US Pharmacopeia sets quality standards for drugs sold in the United States.
At the moment, consumers have no way of knowing where their drugs are produced or assembled, because there are no requirements for country-of-origin labeling of drugs. The counterfeit diabetes test strips were traced to a firm in Shanghai. And when at least 56 people died in Panama last fall after taking cough and allergy medicines, it was discovered that the drugs had been spiked with toxic diethylene glycol sold as harmless glycerin by a Chinese firm. Raw ingredients and finished products can move through a half-dozen countries before landing on a pharmacy shelf. Pharmacies buy from manufacturers or from wholesalers who are licensed by the states. "Our mantra is, the more often a product changes hands, the more likely a counterfeit can be introduced into the supply chain," says Rubie Mages, a former district attorney who is a director of global security for Pfizer, which makes Lipitor and Viagra, probably the world's most counterfeited drug.
The FDA gained the authority to order tainted drugs off the market in 1938, after more than 100 people died in the States from taking medicine made with diethylene glycol. The federal regulatory system now requires manufacturers to test drugs for safety and efficacy before they are marketed, and also to quality-test the raw ingredients they use and the finished product. The FDA sends inspectors to domestic production facilities about every two years to make sure that they're in compliance; the inspections can take months. But the agency's enforcement division doesn't have the resources to inspect more than a tiny fraction of manufacturers overseas. Between 2,000 and 3,000 overseas pharmaceutical manufacturers that sell to the United States are registered with the FDA. Some of those have not been inspected in eight to 10 years, an FDA official told a congressional committee last month. And the suppliers of ingredients to those importers never get a look-over. "The FDA doesn't have the people who can go to these countries and inspect," says William Hubbard, a former associate commissioner for policy and planning at the agency. "The enforcement side has been cut drastically."
The public uproar over the pet deaths from melamine, as well as tainted toothpaste, got the government's attention. Congress has introduced several bills that would require country-of-origin labeling on pharmaceuticals, as well as fees on drug imports to pay for more inspections at the borders. An import-safety task force held hearings in Washington, D.C., last week, with the aim of preparing a report on possible solutions later this fall. And the Department of Health and Human Services is in the midst of negotiations with its Chinese counterpart over how to improve that country's food and drug safety programs. The top priority: the chemicals from which drugs are made. "We're very interested in oversight of the API industry in China," says Murray Lumpkin, deputy commissioner of the FDA's Office of International and Special Programs. In the past year, the standards-setting organization us Pharmacopeia opened offices in India and China, its first outside the United States. Some manufacturers in those countries have courted USP in an effort to prove they meet international standards.
People who rely on generic drugs may have to worry about more than the active ingredients, says Joe Graedon, a longtime champion of generics and coauthor of the 2006 book Best Choices From the People's Pharmacy. Since 2004, when the FDA fast-tracked the approval process for new generic drugs, more and more people have told him they've experienced side effects with a generic that they didn't have with the brand name, or the generic is failing to work at all. He wonders if differences in inactive ingredients or formulations could account for the treatment failures; when a company seeks FDA approval for a new generic, it must prove only that the active ingredient is the same. ConsumerLab.com is testing for differences between some generics and brand names; results are expected later this month.
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