Introduction

On February 28 2017 Senator Bernie Sanders (I-Vt) introduced the Affordable and Safe Prescription Drug Importation Act (S469), which would amend the Federal Food, Drug and Cosmetic Act to allow the importation of drugs from Canada and possibly other countries. The bill has been referred to the Senate Committee on Health, Education, Labour and Pensions. The bill's 19 original co-sponsors include Senators Cory Booker (D-NJ) and Bob Casey (D-Pa), both of whom voted against the drug importation amendment that Sanders offered during the January 2017 budget resolution debate. The bill currently has 21 co-sponsors.

Initial importation from Canada with possibility for expansion

The bill directs the Department of Health and Human Services (HHS) secretary to promulgate regulations permitting the importation of prescription drugs by individuals, wholesalers and pharmacies within 180 days of its enactment. For the first two years, importation would be permitted only from Canada, but could then be expanded to include other countries which are members of the Organisation for Economic Cooperation and Development and which have standards similar to those of the United States pertaining to prescription drug regulation.

Regulation of foreign sellers

Foreign sellers, including foreign pharmacies and wholesale distributors, would be required to be certified by the HHS secretary and could purchase drugs for import into the United States only from Food and Drug Administration-inspected manufacturers.

Standards and limits on drugs for import

Drugs eligible for importation would be required to have the same active ingredient, route of administration and strength as a prescription drug approved in the United States. While individuals would be permitted to purchase a 90-day personal supply pursuant to a valid prescription issued by a US-based provider, certain types of drug, such as biologics and insulin, could be imported only by wholesalers or pharmacies. In addition, controlled substances, compound drugs and anaesthetic drugs inhaled during surgery would be prohibited from import entirely.

Other relevant provisions

The bill would require several supply chain security measures, including importation tracing. It would also require importers to submit bi-annual reports to the HHS secretary detailing information about the importation of qualified prescription drugs.

Further, the HHS secretary would have the authority to suspend the importation of a specific drug or a certified foreign seller for:

  • patterns of importation of counterfeit or recalled drugs; or
  • other related violations.

For further information on this topic please contact Stephanie P Hales, Dora Hughes or Meghan F Weinberg at Sidley Austin LLP by telephone (+1 202 736 8000) or email (shales@sidley.com, dhughes@sidley.com or mweinberg@sidley.com). The Sidley Austin website can be accessed at www.sidley.com.

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