Drug Costs

The Risks of Importation

June 14, 2019 10:17 am

The Maine state legislature this week took initial votes on a bill, L.D. 1272, that would create a program to allow wholesale drug importation from Canada. Lawmakers promise the imported drugs would have to meet standards set by the U.S. Food and Drug Administration (FDA).


That, of course, is in an important caveat since there is ample evidence that drugs from Canada often are counterfeit or were not manufactured in the country at all.


Before getting to that evidence, though, let’s consider the fact that any importation plan would be an additional burden on U.S. law enforcement, which already is struggling to stem the tide of opioids and illegal drugs across the border. In fact, former FBI Director Louis Freeh warns law enforcement and the FDA are so burdened today they could not guarantee the safety of drugs imported from Canada.


Freeh recently updated a report he had issued in 2017 warning state and federal policymakers about drug importation. (Both the 2017 report and the 2019 addendum can be found here.) In the addendum, Freeh writes, “Importation would dramatically expand the potential for unapproved, substandard, counterfeit, and diverted drugs to enter the supply chain endangering public health and safety.”


In 2017, and again this year, Freeh advised that certain measures must be taken if lawmakers want to import drugs, including the need for:


- An extensive review of the adequacy of law enforcement and other regulatory agencies’ authorities (the FDA, U.S. Customs and Border Patrol (CBP) and U.S. Postal Services (USPS)) to address emerging threats;

- A thorough assessment of the FDA’s, the CBP’s, and USPS’ resources to meet inspection needs;

- Changes to existing law to assist the CBP in establishing and improving an inspection protocol to deter counterfeiters from using the USPS to ship counterfeit drugs;

- Improvements to law enforcement training regarding counterfeit drugs;

- Broader efforts to educate the American public about the dangers of illegitimate pharmaceuticals and online pharmacies; and

-Increased grant funding and other support for local task forces, as well as intelligence coordination and fusion centers so that information and intelligence can be shared quickly and efficiently across the federal, state, and local levels about criminal organizations.


Freeh says federal policymakers have made progress on some these recommendations, but notes many have not been implemented. He warns, for example, that federal law enforcement simply “does not have sufficient capacity to implement” importation “without additional resources.” If his recommendations are not implemented, Freeh warns importation “would deplete already limited resources and force law enforcement agencies to make tough prioritization decisions that leave the safety of the prescription drug supply vulnerable.”


In a column in The Hill this past January, former FDA Associate Commissioner Peter Pitts explained why drugs from Canada, specifically, are a threat to the U.S. prescription drug supply. He noted:


- During an anti-counterfeiting operation in 2018, 87 percent of 3,600 packages inspected by Canadian officials contained counterfeit or unlicensed health products.

- Canadian internet pharmacies regularly import drugs from less developed and less regulated countries and “slap on their own labels and ship them elsewhere."

- A single FDA operation found 85 percent of “Canadian” drugs originated in 27 different countries, more than one-third of which were potentially counterfeit.


Pitts also explained that several cities and states have tried importation programs before – and they have failed.


The votes in Maine this week were preliminary. Legislators there still have time to reconsider.