FDA warns against risk of drug imports

The most recent four FDA heads have signed a letter, published Friday by the Margolis Center for Health Policy at Duke University, warning Congress about the dangers of legalizing imported drugs from other countries. The letter warns that these imported drugs expose Americans to substandard drugs, further stating that it would, “harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products.”

The four former heads of the FDA, two from under Obama, and two from under George W. Bush recognize that, while this legalization might make drugs more affordable for Americans, the safety risks are not worth it. Robert Califf and Margaret Hamburg served under Obama, and Andrew von Eschenbach and Mark McClellan served as FDA heads under George W. Bush.

Both Representative Bernie Sanders and President Trump have touted the idea of legalizing imported drugs to lower drug costs. Sanders, along with other Democratic Senators, introduced legislation last month to legalize imported drugs from Canada first. According to the bill, European imports could follow later. Because of United States price controls, drugs in other countries are often cheaper.

However, the letter warns that, “global experience confirms that illicit, ineffective, or adulterated products are readily available on the open market and represent one of the most lucrative avenues of organized crime.” Califf recently stated that, although many of these imported drugs are supposedly from Canada or Europe, many of them are, in fact, from companies based in South America, Eastern Europe, and Russia. This is concerning because these countries do not have the government regulations in place to ensure the veracity and purity of these prescription drugs.

Those who support the drug import bill say that these dangers are overstated, and the drug companies stand to benefit from the failure of this bill. Supporters point out that the Sanders sponsored bill allows only FDA-certified companies to import drugs to the United States. Studies have shown that over 19 million Americans have purchased imported drugs, either online or through personal trips to other countries.

The former FDA heads don’t dispute that information. However, they do express doubt that Congress and the government agencies would be provided with sufficient resources to properly manage the importation program.

While President Trump did make mention of this issue on the campaign trail, saying that he thought Americans should be able to purchase imported drugs to lower their prescription costs, he has not spoken about the issue since his inauguration.