ICYMI: What the experts are saying about importation

Importation - FDA commissioners and other stakeholder comments

Allyson Funk
Allyson FunkMarch 23, 2017

ICYMI: What the experts are saying about importation.

Voices throughout the U.S. and Canadian health care systems have raised concerns about proposed large-scale drug importation schemes. Former government officials, pharmacy groups and experts have called attention to the potential dangers associated with these importation schemes, as well as the lack of cost savings for American patients. Here’s a look at what they’re saying:

  • Four former FDA Commissioners from both Republican and Democratic administrations, Robert Califf, Margaret Hamburg, Mark McClellan and Andrew Von Eschenbach, authored a joint letter to Congress noting that importation “could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard or counterfeit drugs. It could also undermine American confidence in what has proven to be a highly successful system for assuring drug safety.”

  • In a Morning Consult op-ed, former Secretary of Health and Human Services (HHS) Mike Leavitt said he “found it impossible, based on the preponderance of evidence and data before [him], to certify that importation of medicines from unregulated sellers is safe” and noted his “predecessors and successors from both political parties, along with multiple FDA Commissioners, have consistently found that drug importation carries potential dangers that can’t be ignored.”
  • As reported by The Washington Post, former Resident Fellow at American Enterprise Institute and current nominee for FDA Commissioner Scott Gottlieb noted that a 2014 proposed importation 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.”
  • Nearly 170 groups representing patients and the pharmaceutical supply chain (pharmacists, wholesalers and more) wrote to congress raising concerns about these importation schemes. The letter reiterates safety concerns, stating “Whether offered broadly or for a narrow set of medications, there’s never a good time to sacrifice safety. No patient is served well by a drug from an unknown source, that has been stored under unknown conditions, and which contains unknown ingredients because it passed through unlicensed, foreign middlemen who operate beyond U.S. law.”
  • Bloomberg BNA reports that Tim Squire, a partner in the Toronto office of Fasken Martineau DuMoulin LLP and revered expert, said, “Canada's pricing controls don't apply to exports, so there is no guarantee Canadian products would be sold for the same prices in the United States…I don't think there are such huge savings to be had.”

Learn more about the dangers of drug importation here: PhRMA.org/Importation


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