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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.

Australian Gene Patent Bill: BIO Comments to the Australian Senate Committee on Proposed Patent Amendment

Feb 25 2011
BIO believes that the proposed amendment would, if adopted, have significant unintended and adverse consequences in all sectors of biotechnology and for patients and consumers in Australia. This amendment also would fail to affect its intended purpose, which is to advance medical and scientific research and the diagnosis and cure of human illness and disease.

BIO Defending Existing Funding for Bioenergy Programs

Feb 25 2011
BIO submitted a joint letter to Senate leadership urging full funding be maintained for existing bioenergy programs at DOE and USDA in CR legislation to fund the federal government through the remainder of FY11.

BIO Comments to CMS on Draft Update of Chapter 4 of the Medicare Managed Care Manual, "Benefits and Beneficiary Protections"

Feb 24 2011
BIO submitted comments on the draft update which would potentially allow Medicare Advantage plans to restrict access to certain covered Part B drug or durable medical equipment items. BIO urged CMS not to implement the proposed change as it would deny beneficiaries access to medically necessary drugs and biologicals.

BIO Submits Comments on FDA’s Good Laboratory Practice for Nonclinical Laboratory Studies

Feb 22 2011
BIO supports FDA's initiative to revise the Good Laboratory Practice (GLP) regulations to more completely address how nonclinical studies are currently conducted, particularly in light of the fact that the regulations have not been substantially revised since the late 1970's. BIO also supports a quality systems approach to GLP to ensure continual improvement and high quality lab studies, which is embodied in the current GLP regulation. Wherever possible, we also encourage alignment with international standards and principles governing the conduct of nonclinical studies.