Former FDA Commissioners Oppose Drug Importation Proposals in Letter to Congress
Four former commissioners of the Food and Drug Administration warned Congress that allowing personal importation of drugs would lead to a surge in counterfeit and substandard pharmaceuticals, in a letter posted to the Duke University Margolis Center for Health Policy website on March 17 (here). There's some “renewed debate” on allowing personal importation as a means to reduce the cost of prescription medicines, but addressing the serious issue of access to affordable drugs will “not be such a straightforward task,” said the letter, signed by former commissioners Robert Califf, Margaret Hamburg, Mark McClellan and Andrew von Eschenbach.
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
Evidence shows that allowing direct importation will not achieve the aim of lowering drug costs, but will harm patients and consumers and “compromise the carefully constructed system that guards the safety of our nation’s medical products,” the former FDA commissioners said in the letter. Drugs purchased from foreign countries may be substandard, unsafe, adulterated or fake, it said. Because drugs are distributed to countries based on the needs of their respective populations, there is not a surplus of drugs in foreign countries ready for importation into the U.S., which could “exacerbate problems by increasing the likelihood of counterfeit or unsafe products,” the letter said.
Allowing personal importation from FDA-inspected foreign facilities or re-importation of drugs previously exported from the U.S. would not be the same as the current system, because “the drugs could not be tracked and certified by the manufacturer,” the letter said. And though it is possible FDA could administer a personal importation program if it had more resources, “there are many far more urgent priorities for FDA reform that would have much greater benefits for Americans, including more effective ways to improve access to safe drugs,” the letter said.
Congress should take a different approach to addressing the problem of high drug costs, though the four former commissioners differ on what that approach should be, the letter said. Califf, who left FDA on Jan. 20, is still listed as on leave from his former professorship in cardiology at the Duke School of Medicine. His predecessor Hamburg, FDA head from 2009 to 2015, is foreign secretary of the National Academy of Medicine and president-elect of the American Association for the Advancement of Science. Von Eschenbach, FDA head from 2006 to 2009, is president of Samaritan Health Initiatives. McClellan, who led FDA from 2002 to 2004, is director of Duke’s Margolis Center.
Meanwhile, the Pharmaceutical Research and Manufacturers of America advocacy group also warned of the dangers of personal drug importation in a blog post dated March 16 (here), citing concerns that it could increase the burden on law enforcement. “Illegal drug trafficking by global criminal organizations is already a challenge for U.S. law enforcement, and the threat of fake, adulterated and addictive drugs, like counterfeit fentanyl, being imported would only increase if drug importation proposals move forward. Law enforcement agencies, including [CBP], are already overburdened,” PhRMA said.