BIO Comments on Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies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BIO is concerned that while the Draft Guidance and the accompanying Final Rule may internationally harmonize standard definitions for safety reporting, the requirements establish differing standards for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 In order to maximize compliance and reduce the risk of underreporting, BIO requests additional clarification in the Draft Guidance on this question and ask that FDA coordinate with other international regulatory authorities in the spirit of global harmonization to develop a common approach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.

Concerns regarding unilateral actions that the USDA is poised to take in the name of coexistence

Dec 23 2010
BIO letter to Mr. Cass R. Sunstein regarding its concerns on unilateral actions that the U.S. Department of Agriculture (USDA or the Department) is poised to take in the name of coexistence.

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.

Parallel Review of Medical Products

Dec 16 2010
BIO does not believe that the existence of separate, serial FDA and CMS review processes has resulted in significant problems in the review and coverage of drugs and biologicals, and questions whether there is any need for a new parallel process. Sponsors who wish to involve both FDA and CMS in clinical development and premarket review discussions may do so voluntarily under current practice, and we encourage both agencies to maintain this opportunity for early consultation, outside of any formal parallel review process, where it is desired by sponsors.

Climate Change and IP: Letter Urges US to Protect Intellectual Property Rights at Conference

Dec 7 2010
BIO co-signs a letter to Secretary of State Hillary Clinton and Ambassador Todd Stern that argues strong intellectual property protection is key to achieving the innovation and worldwide technology deployment necessary to reach climate change goals.

BIO comments submitted to United States Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS

Dec 6 2010
BIO in response to the November 4, 2010 announcement (the Notice) by the United States Department of Agriculture's (USDA's) Animal and Plant Health Inspection Service (APHIS or the Agency) of APHIS's preparation of a draft environmental assessment (EA) as part of its decision making process to address a supplemental request for partial deregulation of sugar beets genetically engineered (GE) for tolerance to the herbicide glyphosate.

Comments to the Institute of Medicine on the Determination of Essential Health Benefits

Dec 6 2010
BIO submitted comments to the Institute of Medicine (IOM) in response to a survey on the criteria and methods for determining and updating the essential health benefits package.

Medicare Program; Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program

Dec 3 2010
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Centers for Medicare and Medicaid Services' (CMS) Request for Information (RFI) regarding Accountable Care Organizations and the Medicare Shared Savings Program.

Job Creation: Biobased Products Seek Equal Tax Credits

Dec 1 2010
Biobased products and renewable chemicals should be incentivized along with other renewable technologies in Congressional bills aimed at creating jobs, according to letters sent by BIO and biotechnology companies to House and Senate leaders.

BIO comments on the proposed accession of Malaysia to the Trans Pacific Partnership (TPP) negotiations

Nov 22 2010
Parties to the TPP negotiation are a mixture of countries that actively cultivate and import GE crops, as well as those that have yet to develop functioning regulatory systems. Therefore, the TPP offers the potential to achieve a common regulatory approach and disciplines for agricultural biotechnology.