Placeholder Banner

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.

Download Full Comments Below
BIO_Comments_on_FDA_Canadian_Importation.pdf
Discover More
March 18, 2020 FDA Docket No: FDA-2019-D-4964: FDA Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Dear Sir/Madam: BIO thanks FDA for developing this additional guidance on…
March 15, 2020 Re: Docket No. FDA–2019-D-4752: FDA Draft Guidance, Pediatric Study Plans for Oncology Drugs: Questions and Answers BIO appreciates FDA’s efforts to develop a document that outlines questions and answers pertaining to Pediatric…
In the wake of the COVID-19 outbreak, the Biotechnology Innovation Organization (BIO) joins 111 industry groups across sectors in a letter to federal, state and local lawmakers supporting uniform definitions of "critical infrastructure" as outlined…