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Can You Purchase Prescription Medication From Abroad Like Maria Sharapova?

March 11, 2016
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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

Maria’s a very wealthy woman so if she imported a FDA non-approved drug, it wasn’t to save money; which is the primary reason Americans choose this option. Still this is a timely opportunity to have a conversation about policies that will allow Americans to purchase affordable prescription drugs given all of the high-profile cases about exorbitant drug prices in America.

There is evidence that for the last decade and a half that the federal government, but mostly state governments have attempted to draft an enact drug importation laws. In fact, the state of Maine did pass a law allowing its residents to buy prescription drugs from Internet pharmacies in Canada, the United Kingdom, Australia and New Zealand. Not surprisingly, Big Pharma sued the state of Maine over the law and Big Pharma won. The law was eventually struck down because it violates federal law.

But the situation is not as bleak as it appears. We may never have a federal law that allows all-out importation of drugs because of safety reasons, but the FDA generally does not go after individuals who purchase their medications abroad. To date the FDA has not prosecuted any individual for importing a prescription. It does; however, go after companies or groups who buy prescription medications abroad with the goal of reselling them in America.

In regard to drug importation, probably the best we can hope for is that Congress will amend the Food, Drug & Cosmetic (FD&C) Act to include more exceptions that allow more Americans to legally purchase drugs internationally. The best Maria can hope for is that her high level status in tennis doesn’t result in WADA using her as an example and imposing the maximum ban of four years. I’m predicting she gets a four to six month ban and banned from playing in the upcoming Olympic games, which is generous…

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