Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day
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On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of Health and Human Services' Secretary, Tom Price, to lower prescription drug costs and to certify the importation of prescription drugs from Canada, where drug prices, in many instances, are half the cost. This letter follows a previous request from February 14, 2017, that the same senators made to Secretary Price.

The May letter follows on their previous request, which urged the Secretary to exercise authority granted under the Medicare Prescription Drug Improvement and Modernization Act of 2003 ("Act"). The Act provides FDA with the authority to permit pharmacists and wholesale retailers to import prescription drugs from Canada, as well as to issue waivers to individuals to import prescription drugs for personal use. As the letter states, FDA's authority over importation of prescription drugs cannot be exercised unless the Secretary first certifies 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. It is in this context that the senators requested the Secretary to use existing statutory authority to fast-track the approval of less expensive prescription drugs from Canada and thus restore competition to the market.

Acknowledging the difficulty of meeting the standard, the senators proposed that the Secretary limit certification of importation to the following cases: (i) the drug is off patent or no longer marketed in the United States by the innovator company that initially developed the drug; (ii) in cases where there are significant and unexplained increases in price; (iii) 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 (iv) 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 United States.

In addition, senators welcome his support to bring down the costs of prescription drugs through the personal importation program set forth in the Safe and Affordable Drugs from Canada Act, which was reintroduced on January 9, 2017, by Senators McCain and Klobuchar. If the program becomes law, it would allow individuals to import prescription drugs from an approved Canadian Pharmacy if: (i) dispensed by a pharmacist licensed in Canada; (ii) purchased for personal use in quantities not greater than a 90-day supply; (iii) filled using a valid prescription issued by a physician licensed to practice in the United States; and (iv) the imported drug has the same active ingredients, route of administration, dosage form, and strength as a prescription drug approved under the Federal Food, Drug and Cosmetic Act.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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