Imported Drugs Raise Safety Concerns
by Michelle Meadows (staff writer for FDA Consumer)
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."
Limits on Re-Importation
The FD&C Act also states that prescription drugs made in the United States and exported to a foreign country can only be re-imported by the drug's original manufacturer. Even when original manufacturers re-import drugs, the drugs must be real, properly handled, and relabeled for sale in the United States if necessary.
The Medicine Equity and Drug Safety Act (MEDS), enacted in 2000, would have allowed prescription drugs manufactured in the United States and exported to certain foreign countries to be re-imported from those countries for sale to American consumers. Supporters of the bill hoped that lower drug pricing in other countries would be passed along to consumers. But Health and Human Services Secretary Tommy G. Thompson responded by saying that, while he believed strongly in access to affordable drugs, he could not implement the act because it would sacrifice public safety by opening up the closed distribution system in the United States.
Though the law was enacted in 2000, before the bill can take effect, one provision requires that the HHS secretary determine whether adequate safety could be maintained and whether costs could be reduced significantly. Both Thompson and his predecessor, Donna Shalala, concluded that these conditions could not be guaranteed.
"Once an FDA-approved prescription drug is exported for sale in another country, it is no longer subject to U.S. requirements and it can no longer be monitored by U.S. regulators," Thompson wrote in a letter to Sen. James Jeffords (I-Vt.), one of the bill's sponsors. "In addition, it may not have the U.S.-approved labeling. Instead it may have labeling for the country to which it is exported."
Guidance on Personal Use
Although importing unapproved prescription drugs is illegal, the FDA's guidance on importing prescription drugs for personal use recognizes that there may be circumstances in which the FDA can exercise discretion to not take action against the illegal importation.
The personal use guidance was first adopted in 1954, and it was modified in 1988 in response to concerns that certain AIDS treatments were not available in the United States. The guidance allows individuals with serious conditions, such as a rare form of cancer, to get treatments that are legally available in foreign countries but are not approved in the United States.
The current policy is not a law or a regulation, but serves as guidance for FDA personnel. The importation of certain unapproved prescription medication for personal use may be allowed in some circumstances if all of these factors apply:
"While we can appreciate the cost issue, saving money on prescription drugs isn't one of the circumstances," says the FDA's McCallion. "The guidance doesn't condone the use of buying foreign-made versions of drugs available in the United States, even if they are sold under the same name," he says. "They are still unapproved products."
That means if you buy your high blood pressure or other medication from a foreign country because it's cheaper--even though a drug with the same name is approved for sale in the United States--generally the drug will be considered unapproved and the FDA's personal use guidance will not apply. The Drug Enforcement Administration has additional requirements for controlled drugs.
The Same Goes for Canada
Neena Quirion, director of the Maine Council of Senior Citizens in Augusta, has organized bus trips to Canada for her members and estimates that 25 seniors collectively saved about $19,000 on an overnight trip in March. "Paying for drugs is a real hardship for so many people," she says. "One lady takes about 15 different medications."
Quirion says they've obtained prescriptions from a doctor who is licensed to practice medicine in both Maine and Canada and who performs a physical examination on each person before writing prescriptions. "Our feeling is that the quality of the drugs is the same," she says. "Everything's very regulated in Canada."
Greg Thompson, Pharm.D, a pharmacy professor at the University of Southern California, agrees. "Getting drugs from Canada under the doctor's orders is different than getting drugs from Mexico on your own," he says. "Regulations in Mexico aren't as strict."
But even if you obtain drugs from a place or in a manner that you consider to be safe, according to the FDA, you are almost always obtaining unapproved drugs. "The law applies evenly to all countries outside of FDA's jurisdiction," says Thomas McGinnis, Pharm.D, director of pharmacy affairs in the FDA's Office of Policy, Planning, and Legislation.
So what about the belief often mentioned in the media that drugs sold in Canada are exactly the same as drugs sold in the United States--made in the exact same manufacturing plants? Some may be, and some may not. For example, drugs sold and distributed in Canada by Eli Lilly Canada come from the company's manufacturing facilities throughout the world--the United States, Europe, Asia, and South America.
Manufacturing facilities that make drugs for Canadians have been approved and registered by Health Canada's Health Products and Food Branch, the federal agency responsible for regulating drugs sold in Canada. This agency is responsible for approving the product labeling, which must be made available in Canada's two official languages, English and French.
But the FDA does not have authority to approve drugs sold in Canada. And if a Canadian company is selling drugs only for export to the United States, and not to Canadian citizens, Health Canada may not regulate the drugs or the company at all. Drugs coming to the United States from Canada may be coming from some other country and simply passing through Canada. The drugs could also be counterfeit, contaminated, or subpotent, among other things.
FDA experts say it would be hard for you to know whether drugs sold outside of the United States meet FDA standards and have been manufactured in a plant listed on an FDA-approved new drug application. "Even if you did know," McCallion says, "existing law requires you to prove it. The burden is on the importer to prove that the drug meets legal requirements--that includes having an FDA-approved label in English." The fact also remains that a drug made in this country can only be re-imported back into this country by the original manufacturer, he adds.
Barbara Wells, executive director of the National Association of Pharmacy Regulatory Authorities (NAPRA) in Ontario, Canada, says the practice of U.S. residents filling prescriptions in Canada is an issue that her organization is concerned about. "Our members do not feel that Canadian pharmacists should be breaking laws of jurisdictions in which their patients reside," she says.
When it comes to buying prescription drugs online, Canada is dealing with some of the same regulatory challenges that occur in the United States. In May, the Ontario College of Pharmacists announced that it laid charges against The Canadian Drug Store Inc. for operating an illegal Internet pharmacy based in Toronto. The store, which was filling prescriptions written by U.S. doctors for U.S. residents, was charged along with one of its directors with unlawfully operating an unaccredited pharmacy without registered pharmacists.
NAPRA has signed an agreement with the National Association of Boards of Pharmacy (NABP) in the United States, and recently developed a program in Canada modeled after the NABP's Verified Internet Pharmacy Practices Site (VIPPS), a voluntary certification program.
A VIPPS seal of approval indicates that an online pharmacy complies with state licensing and inspection requirements, along with other VIPPS criteria dealing with such areas as patient rights to privacy and authentication of orders.
NABP developed the service in 1999 after consumers complained to state pharmacy boards about rogue sites posing as legitimate pharmacies. Sites can pop up overnight and disappear just as quickly, and there is little the U.S. government can do if you get swindled. The FDA suggests you steer clear of foreign Web sites. If you buy medicine from a domestic site, remember that the legitimate ones require a valid prescription.
The FDA sends warning letters over the Internet to suspicious sites. About 30 percent of Internet sites that receive the FDA's letters stop their illegal activity. The FDA also sends copies of the letters to the home governments of the Web sites when the locations can be identified.
"We seek out the cooperation of foreign governments because we have limited reach in a foreign land," says David Horowitz, director of the Office of Compliance for the FDA's Center for Drug Evaluation and Research. "That is one of the major challenges of Internet enforcement."
How the FDA Works With the U.S. Customs Service
The exact amount of imported drugs that come into the United States is hard to track, and the high volume makes it impossible to examine them all. In one pilot program last year, the Food and Drug Administration and the U.S. Customs Service examined 1,908 packages of drug products from 19 countries that came through a mail facility in Carson, Calif., during a five-week period.
The FDA estimates that a total of 16,500 packages could have been set aside if there were enough resources to handle them. Of the 1,908 packages, 721 were detained and the addressees were notified that the products appeared to violate the Federal Food, Drug, and Cosmetic Act.
The FDA's enforcement efforts focus on drugs for commercial use, fraudulent drugs, and products that pose an unreasonable health risk.
For more information about the U.S. Customs Service, visit the agency's Web site, www.customs.ustreas.gov.
from FDA Consumer. This article originally appeared in the September-October 2002
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