Imported Drugs Safety : Re-Importation, Personal Use, Canada

by Food and Drug Administration (FDA)

(Page 2 of 3)

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:

• If the intended use is for a serious condition for which effective treatment may not be available domestically.
• If the product is not considered to represent an unreasonable risk.
• If the individual seeking to import the drug affirms in writing that it is for the patient's own use and provides the name and address of the U.S.-licensed doctor responsible for his or her treatment with the drug or provides evidence that the drug is for continuation of a treatment begun in a foreign country.
• If the product is for personal use and is a three-month supply or less and not for resale. Larger amounts would lend themselves to commercialization.
• If there is no known commercialization or promotion to U.S. residents by those involved in distribution of the product.

"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.

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.