Business

Four former FDA commissioners denounce drug importation, citing dangers to consumers

The four most recent Food and Drug Administration commissioners are warning Congress that legalizing the importation of drugs from other countries — an idea that has drawn support from both Senator Bernie Sanders and President Trump — is a risky approach that would endanger consumers by exposing them to fake, substandard, and contaminated drugs.

The open letter to members of Congress, posted Friday by the Margolis Center for Health Policy at Duke University, was signed by two former FDA heads who served during the Obama administration — Robert Califf and Margaret Hamburg — and two who served under former president George W. Bush — Andrew von Eschenbach and Mark McClellan.

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While acknowledging that drug importation is designed to give Americans access to less expensive medicines, it also would likely ‘‘harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products,’’ they write.

Late last month, Sanders and several Democrats introduced legislation to allow the importation of drugs, first from licensed sellers in Canada and later possibly from Europe. Medications in many countries are cheaper than in the United States due to government price controls.

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However, the former FDA leaders warn in their letter 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, in an interview Friday, said the vast majority of Internet sites that advertise as being Canadian are actually based in South America, Eastern Europe, and Russia. Consumers have no reliable way of knowing where the drugs actually come from or what’s in them, he said. Nor can recipients be sure they’re getting what they ordered.

‘‘What if you think you are taking a statin, but you aren’t?’’ Califf asked, referring to a cholesterol medication. ‘‘You wouldn’t feel any different. . . . And what if you were 70, with six medical problems being treated with 10 drugs, and you got sick and died. Who would know?’’

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Supporters of drug importation pooh-pooh many of the safety concerns, saying that they can be managed and that the drug industry is exaggerating the risk to thwart change. They note that the Sanders bill mandates drugs be imported only from FDA-certified sellers and requires the agency to inspect manufacturing facilities that produce drugs for export to the United States.

During his campaign, Trump said consumers should be allowed to import drugs from overseas. As president, however, he hasn’t pursued the subject.

In their letter, the former FDA commissioners expressed skepticism that the agency would ever be given enough resources by Congress to police imported drugs. ‘‘Obtaining sufficient resources and expertise to screen and verify the authenticity of every product destined for American consumers presents enormous challenges,’’ they wrote.

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