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.

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.

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 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.

BIO Submits Comments on FDA’s Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters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On Monday, January 11, BIO submitted comments on the FDA's Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters.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.

USDA Proposal to Deregulate Genetically Engineered Alfalfa

Jan 6 2011
The U.S. Department of Agriculture is currently considering whether to deregulate genetically engineered (GE) alfalfa (known as "Roundup Ready" or "RR" alfalfa). Despite USDA’s own environmental impact statement that states that RR alfalfa is safe and is not a plant pest, USDA might impose geographic restrictions on the crop. Not only would that defy scientific precedent and legal authority, but such a policy would burden the majority of U.S. growers by eliminating "farmer choice" and dictating what crops can be grown and where.

New Report Analyzes Impact of Limitations of Current Reimbursement System on Development of Novel Diagnostics

Jan 6 2011

Adopting the technical regulation on requirements for the labelling of food and the identification of raw materials for human consumption which contain genetically modified organisms, and adopting other provisions

Jan 3 2011

BIO Comments on Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies

Dec 28 2010
BIO is concerned that while the Draft Guidance and the accompanying Final Rule may internationally harmonize standard definitions for safety reporting, the requirements establish differing standards for assessing the causality between a drug exposure and a suspected adverse event and may in fact lead to divergence in reporting practices between international regions. In order to maximize compliance and reduce the risk of underreporting, BIO requests additional clarification in the Draft Guidance on this question and ask that FDA coordinate with other international regulatory authorities in the spirit of global harmonization to develop a common approach to causality assessment.

BIO Comments on the Food and Drug Administration Approval Pathway for Biosimilar and Interchangeable Biological Products

Dec 23 2010
On December 23rd, 2010 BIO submitted comments on the Food and Drug Administration Approval Pathway for Biosimilar and Interchangeable Biological Products. BIO also submitted initial comments on November 11, 2010, and were also very appreciative of the opportunity for BIO staff to participate in the Public Meeting held November 2-3, 2010. The comments are grounded by the specific hands-on experience of BIO member companies and highlight the importance that the pathway for the approval of biosimilars protect patient safety and preserve incentives to innovate.