The Letter (and Spirit) of Drug Import Laws (cont.)
To hedge its bets, the FDA cautions that "even if all of the factors noted in the guidance are present, the drugs remain illegal and the FDA may decide that such drugs should be refused entry or seized. The guidance represents the FDA's current thinking regarding the issues of personal importation and is intended only to provide operating guidance for FDA personnel. The guidance does not create any legally enforceable rights for the public; nor does it operate to bind the FDA or the public."
As for the consequences, FDA associate commissioner for planning and policy William Hubbard told the Wall Street Journal in March 2003 that "any party participating in" an import plan in which a health insurer or claims processor helps arrange a purchase in Canada "does so at its own legal risk." The article also quotes Hubbard as saying that "our highest enforcement priority would not be actions against consumers."
"The agency doesn't go after individuals, per se," says Tom McGinnis, PharmD, director of pharmacy affairs for the FDA. "The agency has tended to focus its priorities on people making money from this illegal activity."
McGinnis tells WebMD that the personal importation policy "has been in existence for a long time, probably since the '50s, and that if you read it carefully, only deals with things that are not available in the U.S." McGinnis says that the policy was intended to allow patients with serious, life-threatening conditions who have exhausted all available alternatives in the U.S. to try, under the guidance of their physicians, alternative therapies approved for the condition in other countries.
Next: Getting Prescription Drugs Through U.S. Customs
Anything to Declare?
U.S. Customs, for its part, warns travelers not to assume that medications approved abroad are also legal in the U.S., or that the labeled uses for which a drug is approved elsewhere hold true in the United States. The Customs service also cautions that:
The Customs service warns that "when the type of drug, the quantity, or the combination of various drugs arouse suspicions, U.S. Customs inspectors will ordinarily contact the nearest FDA or DEA [Drug Enforcement Administration] office for advice and will then make a final determination about whether to release or detain the article."
And if all of the above makes perfect sense to you, we'd like to know what you've been taking -- we'd like some, too.
Published Sept. 17, 2004.
SOURCES: Tom McGinnis, director of pharmacy affairs, FDA. FDA Office of Regulatory Affairs. Congressional Budget Office. U.S. Customs Service. Wall Street Journal, March 12, 2003.
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Last Editorial Review: 1/31/2005 8:40:55 AM