Drugs

Senators Urge Some Canadian Drug Imports

David McFarland

— 2 min read
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Sens. Chuck Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) are asking new HHS secretary Tom Price to certify some Canadian drugs for importation into the U.S. under the 2003 Medicare Prescription Drug Improvement and Modernization Act. In a 2/14 letter, the senators say that many of the drugs subject to drastic price increases in the U.S. are available in other countries for a fraction of the cost, and often are still produced by either the original brand manufacturer or a reputable generic manufacturer.

Under the 2003 law, they write, FDA can permit pharmacists and wholesale retailers to import prescription drugs from Canada. FDA also can issue a waiver to allow individuals to import prescription drugs for personal use. “However,” they add, “the law stipulates that the provisions related to importation do not become effective until the Secretary of Health and Human Services certifies the implementation of importation would pose no additional risk to the public’s health and safety and would result in a significant reduction in the cost of covered products to the American consumer. Current circumstances present you with an opportunity to use existing statutory authority to quickly restore competition to the market with the introduction of cheaper imported alternatives.”

The senators say that while the certification standard may be difficult to apply to all drugs from Canada, the law allows the secretary to issue the certification in a targeted manner to address current market conditions in a way that readily meets safety standards. “The policy can also be expressly limited so that it does not negatively affect innovator companies that invested in the development of the drug,” they say.

The letter calls on Price to consider immediately certifying importation of prescription drugs from Canada under these circumstances: 

  •          the drug is off patent or no longer marketed in the U.S. by the innovator company that initially developed it;
  •          there have been significant and unexplained price increases;
  •          no direct competitor drug is currently in the market and introduction of a competitor drug will benefit the prices paid by taxpayers and consumers; or
  •          the drug is produced in another country by the name brand manufacturer that initially developed the drug or by a well-known generic manufacturer that commonly sells pharmaceutical products in the U.S.

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