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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.

2011 Special 301: BIO Comments to USTR

Feb 15 2011
In comments to the U.S. Trade Representative (USTR), BIO stresses the critical importance of protecting intellectual property abroad and made recommendations about which countries to include on the Priority Watch and Watch List, which to elevate as a Priority Foreigh Country, and which countries to monitor.

BIO Submits Comments on FDA’s Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination

Feb 14 2011
BIO requests clarification on the need for "greater than additive activity"; deletion or revision of the criteria for a "compelling reason for why the agents cannot be developed individually"; discussion of co-development of existing compounds for use in combination in unapproved indications; and the inclusion of oncology drugs. BIO also recommends a case-by-case approach for early combination studies and suggests opportunities for ongoing collaboration with FDA.

Statement of Support for Montana SB218

Feb 1 2011
"An Act establishing procedures for sampling plants protected by patent or other intellectual property laws; requiring mediation of claims involving protected plants; providing an exception; providing rulemaking authority; and providing an immediate effective date."

BIO Comments on FDA’s Draft Guidance for Industry on Qualification Process for Drug Development Tools

Jan 24 2011
BIO requests clarification and provides recommendations around the process for qualification of a proprietary drug development tool, rather than through a consortium; the qualification process for biomarkers referenced in prescribing information; inclusion of FDA-Sponsor meeting timelines; public notification of DDTs under development, evidentiary requirements, and reconciliation with previous precedents around patient reported outcomes.

Compensation Tax Fund Will Hurt Farmers and Undermine Coexistence

Jan 20 2011
In response to the current debate over coexistence in agriculture, organic groups are calling for a "compensation fund." This "tax fund" would require developers of agricultural biotechnology products to "pay" into a program that would benefit organic farmers if/when crops are allegedly and/or inadvertently comingled with biotech varieties. Not only would such a program foster conflict among growers, but it would distort the marketplace and place the majority of U.S. farmers at a competitive disadvantage.

Microsoft v. i4i Case: BIO Joins 260 Business, Research Institutions and Organizations to Urge Caution in

Jan 13 2011
BIO joined other stakeholders representing U.S. innovation in all 50 states and the District of Columbia to urge Attorney General Holder and Acting Solicitor General Katyal to proceed cautiously in developing the U.S. government's position in Microsoft v. i4i which was accepted for review by the Supreme Court. We are greatly concerned about the potentially negative consequences for domestic innovation, job growth, and U.S. technological leadership internationally.