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Drug Importation

Can You Purchase Prescription Medication From Abroad Like Maria Sharapova?

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I’m a big fan of professional tennis. Like many tennis fans this week I was eager to hear the scheduled announcement on Monday by one of the biggest stars in the game, Maria Sharapova. Here announcement that she failed a mandatory drug test at the first tennis major of the year, the Australian Open, was a disappointing surprise. Maria admitted taking a drug since 2006 that was just recently banned (January 1, 2016) by the World Anti-Doping Agency (WADA).

The drug is called meldonium (aka mildronate) and the U.S. Food and Drug Administration (FDA) does not approve it—which mean it is not available by prescription in the U.S. But Maria is not an American citizen. She’s a Russian citizen who received her tennis training in the U.S. as a young child and owns several homes here. According to her announcement about the incident, her family physician prescribed meldonium to her to address several health issues.

The questions everyone’s asking now are:

  • Where is her physician’s practice based?
  • Where does she get the drug?
  • Does she import the drug from a country where it is legal to the U.S.?
  • Has the drug ever been administered to her in the U.S. in the ten (10 years) she’s been using it?
  • Did she notify the FDA she was importing the drug and as a non-citizen did she have to?
Maria and her lawyers will eventually provide answers to most of these questions to the International Tennis Federation. In the meantime, I’m interested to see if Maria’s revelations will spark a national conversation about American citizens importing prescription drugs. Currently, it is illegal for Americans to do so, but there is an exception. According to the FDA, Americans may be able to import drugs (not guaranteed) if they meet all of the following conditions:

  • 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, since 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

We Need More Drug Importation Ban Exceptions Continue Reading...
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