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.

Each of the below signatories submitted comments to the United States Department of Agriculture on the June 6, 2019, proposed rule regarding the movement of certain genetically engineered (GE) organisms [Docket No. APHIS-2018-0034] (OMB RIN 0579-AE47). Those comments reflect the priorities and recommendations of our individual organizations as the Agency contemplates its role in the regulation of agricultural biotechnology. While our organizations may not be aligned in all aspects of our comments on the proposed rule, including the ability of developers to self-determine that they meet proposed exemptions, one area in which we do broadly agree relates to the need for pre-market notification from developers to the Agency, which would provide regulatory certainty for developers and additional information to the marketplace and consumers. We believe there is an opportunity for this rule to do more in that regard.

The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Energy and Commerce Subcommittee on Environment and Climate Change hearing entitled, “Reduce, Reuse, Recycle, Reform: Addressing America’s Plastic Waste Crisis.”