The open letter to members of Congress, which was 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.
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, the independent senator from Vermont, and several Democrats introduced legislation in the Senate and House 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 because of government price controls.
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 that 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?” he asked, referring to medication to control cholesterol. “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?”
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.
Some took issue with the commissioners' letter. "The Internet has been a lifeline of affordable medicines, imported for personal use by using safe international online pharmacies that require valid prescriptions," said Gabriel Levitt, president of PharmacyChecker.com, which verifies the credentials of overseas pharmacies. He pointed to a Kaiser Family Foundation study that found 19 million Americans have bought imported drugs, including via the Internet.
Sanders, who has organized bus trips with his constituents to buy drugs in Canada, contends that if the government can ensure the safety of imported food, it can also ensure the safety of imported drugs. “There is no argument,” he said at a recent news conference. “The drugs that come into this country must be 100 percent safe, and we will do that. We will not tolerate rogue outfits.”
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.
Scott Gottlieb, a physician who the White House recently announced would be nominated to lead the FDA, agrees with his predecessors. He said in a March 2016 article in Forbes that importation wouldn't achieve its aim of providing cheaper drugs but would pose significant cost and safety problems.
Pharmaceutical companies will not “simply ramp up the production lines to accommodate new demand, if it means that the drugs will be imported into the U.S. to skirt their tiered pricing,” he said. “Nor will the foreign countries allow their local supply to be skimmed off, only to create local shortages of important medicines.”
Putting in an adequate FDA regulatory system for drug imports would be prohibitively expensive, he added.
“I worked on sketching an importation scheme for the FDA regulation of imported drugs when it looked like similar legislation would pass in 2004,” noted Gottlieb, a former official both there and at the Centers for Medicare and Medicaid Services. “That scheme would have added so much cost to the imported drugs, they wouldn’t be much cheaper than drugs sold inside our closed American system.”
While current law bars the importation of drugs, the FDA usually looks the other way when people bring small amounts back from Canadian pharmacies for their personal use. That's because it's the Internet pharmacies, not the brick-and-mortar Canadian ones, that worry regulators, Califf said.
By contrast, the “closed” U.S. drug distribution system, as overseen by the FDA, ensures good manufacturing practices and the quality and security of an increasingly complex supply chain, the letter notes.