Imported Drugs Safety: Benefits of a Closed System

by Food and Drug Administration (FDA)

Selene Seguros Rios was 18 months old in 1999 when she received two injections of a pain and fever drug called Neo-Melubrina (dipyrone) in an illegal backroom clinic in Tustin, Calif. That was 20 years after the Food and Drug Administration had banned the drug in the United States because of potentially fatal side effects, including a drop in white blood cells that hampers the body's ability to fight off infections.

Selene died soon after the shots. Her death set off a crackdown in December 2000 on smuggling drugs from Mexico and selling them at swap meets, gift stores, clothing stores, meat markets and other retail establishments in Southern California.

"We've found drugs that were stored in tin containers and car trunks," says Daniel Hancz, Pharm.D., a pharmacist with the Health Authority Law Enforcement Task Force (HALT) in Los Angeles, an organization of police officers and other law enforcement personnel with special training in pharmaceuticals. HALT was launched as part of the crackdown, and task force members have confiscated a variety of prescription drugs being sold illegally.

Experts say the problem mirrors what goes on in nearby Mexico, where easy access to prescription drugs is common. Marv Shepherd, Ph.D., director of the Pharmacoeconomic Center at the University of Texas at Austin, places drugs available in Mexico into two categories. "Plenty of drugs that require a prescription in the United States — like antibiotics, cardiac drugs, and birth control pills — are available over the counter in Mexico," he says. "Then there are controlled substances like Valium, which you do need a prescription for in Mexico."

The FDA's Office of Criminal Investigations in Los Angeles has teamed with HALT to uncover major black market pharmacy rings selling Spanish-labeled pharmaceuticals. Ring members have been arrested and accused of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). Local lawmakers have stiffened penalties, and many illegal pharmacies have been shut down. Other drug sellers have taken their businesses underground, moving from storefronts to private homes in an attempt to hide.

As in Selene's case, some criminals have falsely claimed to have a medical background and not only illegally sold drugs, but administered injections. Hancz says that HALT has seized prescription drugs found mostly in Latino, Asian, and Russian immigrant communities, where some undocumented immigrants, fearing that their immigration status may be discovered, have sought health care in back rooms. The U.S. Attorney's Office in the Central District of California has indicated that legitimate or state-licensed clinics exist where immigrants can be treated safely regardless of immigration status.

The list of safety risks is long, but the principal problems involve the use of prescription drugs without a physician's supervision, and the danger of buying drugs of unknown origin and quality. "I've seen eye medications that look like they're 20 years old," Hancz says. "The drugs could be old, contaminated, or counterfeit. And if you experience some kind of allergic reaction or other side effect, it's hard to trace the problem and treat it."

Whether you're searching for a cheaper price or dodging the doctor's office, the FDA warns against using unapproved drugs. And just because a drug is approved in a foreign country, that doesn't mean it's approved in the United States. Drug standards and regulations vary from country to country and the FDA is responsible only for those marketed and sold inside the United States.

Joe McCallion, a consumer safety officer in the FDA's Office of Regulatory Affairs, sums it up this way: "If you buy drugs that come from outside the U.S., the FDA doesn't know what you're getting, which means safety can't be assured."

Benefits of a Closed System

Under the FD&C Act, the interstate shipment of any prescription drug that lacks required FDA approval is illegal. Interstate shipment includes importation — bringing drugs from a foreign country into the United States.

Drugs sold in the United States also must have proper labeling that conforms with the FDA's requirements, and must be made in accordance with good manufacturing practices.

As part of the FDA's high standards, drugs can only be manufactured at plants registered with the agency, whether those facilities are domestic or foreign. If a foreign firm is listed as a manufacturer or supplier of a drug's ingredient on a new drug application, the FDA generally travels to that site to inspect it.

After the FDA approves a drug, manufacturers still are subject to FDA inspections and must continue to comply with good manufacturing practices. "With an unapproved drug, you can't be sure that it has been shipped, handled, and stored under conditions that meet U.S. requirements," McCallion says.

Along with legal requirements on manufacturing, U.S. pharmacists and wholesalers must be licensed or authorized in the states where they operate, and limits on how drugs can be distributed lessen the likelihood that counterfeit or poor quality drugs will turn up. It's because of such safeguards that the process of getting drugs onto U.S. pharmacy shelves is commonly referred to as a "closed" distribution system.

Counterfeit drugs — phony replicas of pharmaceuticals — can surface anywhere. Historically, they have been more common in foreign countries than in the United States. And while the Internet has given customers the convenience of buying drugs from the privacy of their own homes, it's also opened up windows for crooks to crawl through.

In an investigation that ended in the indictment of seven people and five companies in the spring of 2002, undercover agents in the Manhattan District Attorney's Office in New York bought more than 25,000 counterfeit Viagra pills. They pretended to sell the impotence pills and uncovered four supply streams from China and India.

Some of the little blue pills arrived in the mail stuffed inside a teddy bear and stereo speakers. The exporters used a machine to punch the pills with Pfizer's logo, and intermediaries sold the pills over the Internet to brokers and consumers.

In this case, all the counterfeit pills tested had some of Viagra's active ingredient (sildenafil citrate) with varying potency, according to Barbara Thompson, a spokeswoman for the Manhattan District Attorney's Office. With fake drugs, "you could be getting some of an active ingredient or you could be getting nothing at all," she says.

That's what happened with a batch of Viagra worth $150,000 that HALT recently seized from Los Angeles gift shops. "It looked perfect," says Hancz. "But there was nothing there — just lactose, dye, and other filling agents."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.