Sunday, February 01, 2004
by Daniel J. Schulte, J.D.
MDA Legal Counsel
Published in the February 2004 issue of the Journal
Dear Dan Schulte: There have been many articles in the news lately regarding the importation of drugs from Canada. These articles seem to indicate that importing drugs from Canada is illegal. However, many of my patients tell me that they travel to Canada to purchase needed drugs at deep discounts or obtain drugs from Canada at a discount via the Internet and mail order pharmacies. Is it legal to import drugs from Canada? Can I legally provide assistance to my patients who are importing drugs from Canada?
Answer: No. The importation of a drug (including the re-importation of a drug that was manufactured in the United States) from Canada or any other country is illegal pursuant to the Federal Prescription Drug Marketing Act (“PDMA”) and the Federal Food, Drug and Cosmetic Act (“FDCA”). There is one very narrow exception to this prohibition, which is discussed below.
The prohibition on importing drugs is surprising to many, due to the current prevalence of the practice, advertisements by online and mail-order pharmacies that facilitate illegal importation, as well as the lack of enforcement of the prohibition by the federal Food and Drug Administration. However, the FDA has recently increased enforcement of the prohibition. On Sept. 11, 2003, the U.S. Department of Justice, on behalf of the FDA, filed a complaint in a U.S. District Court against Rx Depot, Inc., and Rx Canada, L.L.C. The complaint seeks an injunction against these two companies to stop them from the further importation of drugs. The FDA has also announced that warning letters have been sent to several other companies that are engaged in similar activities.
The FDA’s allegations are not just that Rx Depot, Inc. and Rx Canada, L.L.C., are engaged in the illegal importation of drugs but that they also are actively facilitating and encouraging others to illegally import drugs through their Web sites, mailings, advertisements and other means.
A knowing importation of a drug could subject the violator to imprisonment for up to 10 years and/or a fine of up to $250,000. Since the FDA has begun to pursue claims arising from the facilitation of the illegal importation as well as the illegal importation itself, dentists should not advise their patients to import drugs. Dentists should also not provide Web site or other addresses, phone numbers, advertisements, or other materials to their patients. Such information could be used in a case against the dentist alleging that the dentist has encouraged, aided and/or abetted a patient in illegally importing drugs.
There is currently one exception to the prohibition on importing drugs. This exception is contained in the FDA’s stated policy of not taking enforcement action against individuals who import a 90-day supply or less of drugs for personal use if the individual can substantiate that:
the use of the drug is for a serious condition for which effective treatment is not available in the United States;
there is no known commercialization or promotion of the drug in the United States;
the drug is not considered to represent an unreasonable risk; and
the drug is for the individual’s own use and has been prescribed by a physician licensed in the United States responsible for the individual’s treatment.
A potential future exception to the ban on importing drugs is contained in the Medicare Prescription Drug and Modernization Act of 2003, which passed Congress in November of last year. This bill allows the secretary of the Department of Health and Human Services to create regulations allowing the importation of drugs from Canada.
For the time being, dentists should not encourage, aid and/or abet their patients in the illegal importation of drugs.
Send questions for publication to Dan Schulte, MDA Journal, 230 N. Washington Square, Suite 208, Lansing, MI 48933-1392.