Consumers shopping for medications on the Internet often are getting convenience, a good price and the cloak of privacy, but they may not be getting the real thing.
A burgeoning multibillion-dollar industry of counterfeit drugs is keeping regulators busy and leaving the public vulnerable.
These medicines can deliver too little, too much or none of the active ingredient and sometimes are adulterated with dangerous chemicals or contaminated by unsanitary manufacturing or storage conditions.
The FDA in recent years has confiscated millions of dollars' worth of counterfeit medicine. The agency, in partnership with international regulatory, customs and law enforcement agencies from 100 countries, shut down thousands of Internet pharmacies selling illegal drugs and seized about $10.5 million worth of pharmaceuticals during a weeklong crackdown on counterfeit and unapproved medications that launched in late September.
But such enforcement action isn't nearly enough to stop the proliferation of phony medicine, FDA officials concede.
"This is a drop in the bucket," said Ilisa Bernstein, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "We don't know how many websites are out there, but there are a lot more."
It is illegal in the United States to sell medication without a valid prescription. All U.S. pharmacies, including those offering drugs online, must be licensed in the state where they are based or where they do business.
Foreign pharmacies can be licensed in the United States only if they follow all state and federal laws and they distribute only FDA-approved products. No foreign pharmacy has met those requirements, said Carmen Catizone, executive director of the National Association of Boards of Pharmacy.
Yet consumers can access tens of thousands of illegal online pharmacies, many of them based overseas. Buying drugs under these circumstances is a violation of the law.
"It's as if they are going to the corner and buying drugs from a drug dealer," said Dr. Bryan Liang, director of the San Diego Center for Patient Safety at the University of California, San Diego School of Medicine.
Bernstein said it's impossible to know exactly how many people have died or been hurt by taking counterfeit drugs.
Experts say some of the illegal operations are based in the United States, often with an elaborate cast of participants who make, sell and distribute the drugs. Many of the drug ingredients come from overseas.
Eli Lilly and Co. is one of the drug makers battling the problem.
"Sometimes one criminal operation will make the packaging with our name brand on it," said Jeannie Salo, director of Lilly's global anti-counterfeiting operations. "Another operation may make the ingredient, which is not the (real) thing. Another person might operate an Internet site."
The appearance of fakes can be convincing, she said. "In some cases, you'd never know unless you tested it," Salo said.