BIO Comments on Implementation of Physician Transparency and Reporting Provisions of PPACA

Apr 7 2011
BIO supports the goal of providing greater transparency regarding financial relationships with health care providers and believes that notice and comment rulemaking is necessary to fully and fairly address the issues raised by the statutory provisions. These issues are complex and largely of first impression in the federal arena.

Improving the Regulation of Plant Incorporated Protectants: BIO comments on Docket ID No. EPA-HQ-OA-2011-0157

Apr 4 2011
In 2007, the Environmental Protection Agency (EPA) implied that it may subject plant-incorporated protectants, or PIPs, to the establishment registration and facility-based production reporting requirements developed to address concerns with pesticide production. The substances used in PIPs are typically naturally occurring proteins that are only harmful to a narrow range of pests. BIO submitted comments to the EPA stating that the additional regulation would discourage innovation and could cause disruption in U.S. agriculture.

Strategy for American Innovation: BIO Comments to the U.S. Department of Commerce

Apr 1 2011
BIO submitted comments in response to the Request for Comments on the Strategy for American Innovation issued by the U.S. Department of Commerce. BIO addressed policies relating to government research and development, entrepreneurship, intellectual property, and incentives to innovate. BIO encouraged the Department of Commerce to help create an environment conducive to risk-taking and one that will unleash the tremendous potential of biotechnology.

The American Research and Competitiveness Act: BIO supports the Research and Development Tax Credit

Mar 24 2011
BIO submitted letters of support for the American Research and Competitiveness Act of 2011 (HR 942) to the lead House of Representatives sponsors.

Coalition Urges Enactment of Patent Reform Legislation to Drive Job Growth and Innovation

Mar 24 2011
BIO joined with 97 other manufacturers, scientists, researchers, academic institutions, and businesses to urge the U.S. House of Representatives to enact patent reform into law in order to strengthen our country's patent system which will help get breakthrough products to market faster, maximizing our opportunities for job growth.

Comments in Opposition to a North Dakota Proposed Vaccine Purchase Program

Mar 23 2011
BIO testified before the North Dakota House of Representatives committee on March 23 in opposition to SB 2276, a bill that would create a state-run vaccine purchasing program with unnecessary marketplace restrictions harmful to start-up companies. The bill was subsequently favorably amended.

BIO Comments on FDA Transparency Initiative: Improving Transparency to Regulated Industry

Mar 8 2011
Overall, BIO applauds FDA's commitment to improving transparency to manufacturers, and believes that the report Improving Transparency to Regulated Industry includes many common sense approaches for enhancing FDA transparency and represents a good starting point on which to base future enhancements. We also request that the Agency re-consider its position on several significant matters that represent missed opportunities.

BIO comments on Appendix 3 of the Report on the Facilitated Work Session (CX/FL 11/39/13) of the Codex Committee on Food Labeling (CCFL

Mar 4 2011
BIO strongly urges the Codex Committee on Food Labeling to discontinue work on food labeling and claims for food, feed and food ingredients, including foods derived from modern biotechnology, since existing Codex text adequately covers such labeling considerations.

BIO comments on Draft Environmental Assessment: Use of Genetically Modified, Glyphosate-Tolerant Soybeans and Corn on National Wildlife Refuge Lands in the Mountain-Prairie Region

Mar 4 2011
BIO urges the Fish and Wildlife Service to allow other GE herbicide-tolerant crops (in addition to GE glyphosate-tolerant corn and soybeans) to be planted on National Wildlife Refuge System lands. Rotating crops such as these will help reduce the risk of herbicide resistant weeds and have the least impact on the environment.

BIO’s Comments on the Centers for Medicare and Medicaid Services (CMS) 2012 Draft Call Letter

Mar 4 2011
BIO expressed concerns about the discriminatory effect of the specialty tier in Part D and encouraged CMS to focus on patient access in its ongoing refinement of the program.