In the FAQs section of FDA’s consumer web site (here), it answers the question: “Why can’t I import some drugs that are approved and sold in the United States?” thusly:
“Many drugs obtained from foreign sources that claim or appear to be the same as U.S.-approved drugs are, in fact, of unknown quality and may even be counterfeit. There is also a possibility that drugs coming to U.S.consumers through Canada, or that claim to be from Canada, may not actually be Canadian drugs. FDA cannot assure the authenticity, safety, or effectiveness of drugs from foreign countries.”
However it does allow an exception at its discretion: “FDA, however, has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:
- The drug is for use for a serious condition for which effective treatment is not available in the United States;
- There is no commercialization or promotion of the drug to U.S. residents;
- The drug is considered not to represent an unreasonable risk;
- The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and
- Generally, not more than a 3-month supply of the drug is imported.”
However, the FDA has allowed prison officials in various states to import sodium thiopental after the drug’s U.S. manufacturer announced last year that it would no longer produce it.
As reported in the Washington Post (see here), U.S. District Judge Richard Leon blocked the importation of sodium thiopental on grounds the Food and Drug Administration “ignored the law in allowing it into this country.” The Obama administration argued it had discretion to allow unapproved drugs into the U.S. Leon said the FDA’s actions were “contrary to law, arbitrary, capricious, and an abuse of discretion.” He said that plain language of the law says that an article that appears to be misbranded or unapproved “shall be refused admission.”
FDA cites safety concerns when it enforces the law of which Judge Leon speaks. A case in point, was the importation of tainted cancer drug Avastin (see “The Fake Avastin Supply Chain: China, Syria, Denmark, Switzerland, UK, US, Doctors“).
Ironically, Judge Leon cited the same safety concerns:
“By opening up the ‘closed’ drug system by allowing an unapproved drug — thiopental — into the United States, defendants jeopardize their own system and threaten the public health by creating a risk that thiopental could incorrectly end up in the hands of the general public,” he wrote.