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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’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.

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 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 Testifies at FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology

Mar 2 2011
Given the significant morbidity and mortality often associated with rare and orphan diseases, the unmet medical need, the societal costs, and the challenges of conducting trials in these patient populations, BIO believes that the current regulatory environment and FDA's review processes need to be re-evaluated and modified for orphan products. The regulatory approval pathway needs to be predictable, faster, and one that more clearly balances benefit/risk for these orphan disease patients and their families. The testimony urges publication of additional guidance on orphan drug development, consideration of alternative approaches to demonstrating efficacy, the greater use of surrogate endpoints, enhancement of the FDA-Sponsor communication processes, and the understanding and acceptance of appropriate risk tolerance.

Value-based Insurance Design in Connection with Preventive Care Benefits

Mar 1 2011
On February 29, 2011 BIO commented on the design aspects of preventive care benefits in value-based insurance plans.

Biofuels and the Environment: EPA Report to Congress

Feb 28 2011
BIO says potential impacts from biofuels should inform, but not impede, realization of potential benefits from biofuels in comments on EPA Draft report, Biofuels and the Environment.