Lawmakers Introduce Prescription Drug Importation Bill to Ease High Costs

Several members of Congress are gearing up to address high prescription drug prices in the wake of President Trump’s promise to crack down on the pharmaceutical industry.

Senators Bernie Sanders, Cory Booker, and Bob Casey introduced a new bill this past week that would allow the importation of prescription medications from licensed Canadian pharmacies. The legislation, named the Affordable and Safe Prescription Drug Importation Act, would permit the United States to import medications from Canada, where drug spending is significantly lower than in the United States.

The bill outlines importation provisions including safeguards and consumer protections, such as FDA certification of foreign sellers, a clear definition of what drugs may be imported, and supply chain security requirements. Imported drugs must have the same active ingredient, route of administration, and strength as its US-approved counterpart. The bill would instruct the Secretary of Health and Human Services, within 180 of its enactment, to issue regulations that allow wholesalers, licensed US pharmacies, and individuals to import qualifying prescriptions drugs manufactured at FDA-inspected facilities from licensed Canadian sellers.

Reps Elijah E. Cummings and Lloyd Doggett introduced a companion bill in the House as well. Both bills would authorize the secretary of Health and Human Services to allow immediate importation from Canada and permit importation from other advanced countries after 2 years.

“Prescription price gouging threatens both the health and financial security of too many Americans — over pricing is not limited to one pharmaceutical manufacturer, one CEO, or one class of drugs,” Doggett said in a press release.

Previous importation proposals have been shot down due to safety concerns, but supporters of the new bill note added safety measures. Still, opponents view imported drugs as a hazard to patient health.

Pharmaceutical Researchers and Manufacturers of America (PhRMA) released a statement condemning prescription drug importation, due to the potential of counterfeit drugs entering the United States that could put American patients at risk. PhRMA states that, “Even drugs that supposedly come from Canada are frequently not made or processed there, but actually come from counties with lax regulatory systems.”

Additionally, the Partnership for Safe Medicines sent a letter, signed by 170 groups, to members of Congress to express concern over the importation proposals.

“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 US law,” the letter stated.

Reference

Affordable and Safe Prescription Drug Importation Act Introduced to Help Lower Skyrocketing Cost of Medicine [news release]. Washington. Sen. Sanders’ website. https://www.sanders.senate.gov/newsroom/press-releases/affordable-and-safe-prescription-drug-importation-act-introduced-to-help-lower-skyrocketing-cost-of-medicine. Accessed Mar. 2, 2017.

The Partnership for Safe Medicines letter to Congress — February 28, 2017 [news release]. PSM’s website. http://www.safemedicines.org/2017/02/psmletter2017.html. Accessed Mar. 2, 2017.

Why drug importation threatens patient safety [news release]. PhRMA’s website. http://catalyst.phrma.org/why-drug-importation-threatens-patient-safety. Accessed Mar. 2, 2017.