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BIO Comments on FDA’s Proposal on Importation of Prescription Drugs from Canada

Re: Importation of Prescription Drugs (Docket No. FDA-2019-N-5711)

March 11, 2020

The Biotechnology Innovation Organization (“BIO”) would like to submit the following comments regarding FDA’s recent proposal to implement aspects of the Canadian importation provisions of Section 804 of the Food Drug & Cosmetics Act (“FD&C Act”).

BIO and our members have long-standing concerns with the considerable public health and safety risk, and the purported cost effectiveness, of prescription medicine importation. We recognize that Congress, when enacting section 804 excluded biological products from the definition of “prescription drug” due to their more complex production and safety profiles. Even with this exclusion, however, we believe that implementing this rule will still pose considerable risks to the public health and safety and will not result in a significant reduction in cost of imported prescription drugs to the American consumer.

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