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Council of State Bioscience Associations 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 Council of State Bioscience Associations (“CSBA”) appreciates the opportunity 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”).

CSBA represents state and regional life science organizations across the country, and our members are dedicated to supporting the development and delivery of innovative life-enhancing and life-saving products. Our organizations represent the backbone of America’s biopharmaceutical sector, including companies researching and developing the next generation of life saving cures. We are committed to ensuring that Patients have access to the treatments they need when they need them, and we support policies aimed at improving access to those groundbreaking therapies and treatments. We also firmly believe that lowering the costs Patients pay at the pharmacy counter should be a central tenet of any measure aimed at addressing the cost of prescription treatments.

As outlined in comments submitted by both the Pharmaceutical Researchers and Manufacturers Association (PhRMA) and the Biotechnology Innovation Organization (BIO), this program is unlikely to achieve any savings and thus run afoul of the statute’s mandate that programs operate in a manner that delivers significant savings to the US consumer.

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