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BIO Submits Comments on FDA’s Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination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BIO Comments on FDA’s Draft Guidance for Industry on Qualification Process for Drug Development Tools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.

BIO Comments to CMS on Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012

Jan 11 2011
While BIO supports CMS' efforts to eliminate pharmaceutical waste under the Medicare Part D program, we question whether the proposed requirement of 7-day dispensing in the long-term care setting is necessary and has been thoroughly evaluated for potential negative impacts on patient care.

President's Council of Advisors on Science and Technology (PCAST)

Jan 11 2011
Public oral comments by David Edwards (BIO) to President's Council of Advisors on Science and Technology (PCAST) regarding the need to increase funding for agricultural research in research agencies and for extramural grants.

BIO Submits Comments on FDA’s Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters

Jan 11 2011
On Monday, January 11, BIO submitted comments on the FDA's Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters. The comments state that generally, this guidance document outlines the content and format requirements for a Dear Health Care Provider Letter (DHCP) letter, which BIO believes is very helpful to the Sponsor in writing the letter. The comments suggest several recommendations to be considered for the Final Guidance relating to alignment with REMS, clarification of audience beyond physicians, assessing the effectiveness of DHCP letters, and clarification of inclusion of product risk information.

Ag, Energy Groups Renew Call for Full Farm Bill Energy Funding

Jan 11 2011
BIO and 23 other renewable energy groups have joined together in a letter to the White House requesting full funding and support of the Department of Agriculture's renewable energy program in the President's Budget for fiscal year 2012.