Partnership for Safe Medicines Statement on Reckless and Politically-Motivated Federal Drug Importation Proposal

Partnership for Safe Medicines Statement on Reckless and Politically-Motivated Drug Importation Proposal

Washington, D.C. (July 31, 2019) – Shabbir Safdar, executive director of the Partnership for Safe Medicines, released the following statement in response to today’s announcement by HHS Secretary Alex Azar and FDA Commissioner Ned Sharpless:

“Less than a year and a half ago, Secretary Azar publicly called drug importation “a gimmick.” He was right then, but is wrong today. Since Secretary Azar’s initial comments, the FDA has estimated that 99.1 percent of drug products entering the U.S. through international mail in 2019 are non-compliant with agency standards. Throughout our communities, we hear about deaths due to illicit substances. There are countless examples of Canadian criminals shipping dangerous counterfeit medicines to Americans. Let us be clear: Political grandstanding doesn’t create safety, and every time our leaders cut corners on regulatory safeguards for political expediency, Americans suffer.

“The safety of America’s drug supply is not a political game. Every HHS Secretary in modern history has refused to entertain the dangerous idea of allowing drug importation, despite careful consideration and intense pressure. Importation simply can’t be implemented (look at Vermont and other states that have tried) and is merely a political mirage that provides a talking point at the expense of people’s health.

“Today’s gimmick by Secretary Azar and Commissioner Sharpless doesn’t equate to responsible governing. It’s regulatory surrender that is unsafe and will not bring down prices in any meaningful way. Voters, pharmacists, patients, law enforcement officers and other stakeholders are watching in full view, likely with one question in mind: Why on earth would our government seek to put lives at risk to pursue a policy that doesn’t work?”


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Additional information

PSM has strong concerns about the sudden embrace of importation after seventeen years of HHS Secretaries and FDA Commissioners consistently saying importation is unsafe and unlikely to save money.

  1. The safety of America’s drug supply is not a political game. Every HHS Secretary and FDA Commissioner for seventeen years has said so, including Secretary Azar himself up to one year ago. Secretary Azar called importation a “gimmick”
  2. Multiple states, including Illinois, Minnesota, and Maine have experimented with importation and failed to succeed. All of those programs were shuttered and failed to make any lasting change to drug pricing issues.
  3. No state importation scheme has ever been able to sustain economic savings that offset their costs, and all of them have had safety lapses.
  4. Hundreds of millions of dollars has been invested in the Track and Trace system. Canada has no Track and Trace system. This proposal will circumvent Track and Trace and endanger patients.
  5. We are at the highest level of attack we’ve seen on the safety of the drug supply in a decade. FDA staff testified on July 16th that 99.1% of the drug products this year through international mail were found to be unsafe.
  6. Nearly every law enforcement officer in this country has had contact with a counterfeit opioid during the crisis, no matter how big or how small the jurisdiction. This is not the time to implement importation and make the existing counterfeit problem worse by creating attractive smuggling routes into America.
  7. Canadian patient advocates and healthcare professionals have all expressed their opposition to this plan because of shortages in Canada.

Finally, we’d like to point out that it was Secretary Azar himself who, just a year ago, branded importation as a gimmick. Nothing has changed in the last year that would validate the sudden decision that importation can suddenly be made safe.