FDA's Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets

Apr 18 2011
BIO supports the Agency's efforts to fully utilize new electronic health care data sources for post-approval pharmacoepidemiologic studies. These new data resources offer great promise to revolutionize the practice of pharmacovigilance with more timely and cost-effective methods for conducting post-market studies, but great care must be taken to minimize the potential for confounding and bias. We hope the Draft Guidance will provide additional transparency in scientific exchange between FDA and Sponsors when initiating appropriate pharmacoepidemiological studies in a regulatory context. With this goal in mind, we request clarification of several aspects of the Draft Guidance, particularly around the process for submitting and reviewing study protocols.

Taking Measure of Countermeasures: How Biotechnology Can Help Protect the United States

Apr 13 2011
In testimony given to the to the Committee on Homeland Security's Subcommittee on Emergency Preparedness, Response, and Communications, Phyllis Arthur reviews government and biotechnology industry efforts to protect the homeland through accelerated research, development, and acquisition of chemical, biological, radiological and nuclear medical countermeasures.

Renewable Fuel Standard: BIO Asks Congress to Maintain Commitment

Apr 13 2011
The Renewable Fuel Standard provides the market and regulatory certainty necessary to drive private investment and maintain progress in research and development of advanced biofuels, BIO said in written testimony submitted to the Senate Environment and Public Works Committee.

Testimony on Rhode Island Labeling Bill

Apr 13 2011
The Rhode Island state legislature is considering a bill (House Bill 5629) requiring mandatory labeling of foods produced with agricultural biotechnology or foods that contain biotech ingredients. BIO submitted testimony opposing the measure to the House Committee on Health, Education and Welfare, saying that food labeling requirements should be science-based to give consumers meaningful information about the foods they buy and eat.

Clean Energy: Biomass Should Qualify for Standard

Apr 11 2011
In comments to the Senate Energy and Natural Resources Committee's "Clean Energy Standard White Paper", BIO argues that biomass should qualify for renewable energy credits.

BIO Comments on FDA's Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations; Availability

Apr 7 2011
BIO supports the ongoing integration of electronic health records (EHR) into the healthcare delivery system and industry adoption of electronic data capture (EDC) systems, and we are hopeful that these systems will introduce new capabilities and efficiencies into the clinical trial enterprise. BIO members welcome technological advances that will assist them in conducting clinical investigations in a more efficient manner. In fact, smaller emerging companies not burdened by legacy systems and practices may have greater flexibility and willingness to adopt new EDC systems. However, while BIO appreciates the principles outlined in the Draft Guidance, many of the responsibilities placed on the investigator remain ambiguous, and may create more potential burdens and uncertainty than clarification for biotech companies involved in clinical investigations.

Biotech Leader Provides Testimony at Congressional Hearing on SBIR/STTR Renewal

Apr 7 2011
The House Subcommittee on Healthcare and Technology held a hearing on The Creating Jobs Through Small Business Innovation Act of 2011, a bill that would reauthorize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which help fund small innovative companies on the brink of new technologies and discoveries.

BIO Comments on Implementation of Physician Transparency and Reporting Provisions of PPACA

Apr 7 2011
BIO supports the goal of providing greater transparency regarding financial relationships with health care providers and believes that notice and comment rulemaking is necessary to fully and fairly address the issues raised by the statutory provisions. These issues are complex and largely of first impression in the federal arena.

Improving the Regulation of Plant Incorporated Protectants: BIO comments on Docket ID No. EPA-HQ-OA-2011-0157

Apr 4 2011
In 2007, the Environmental Protection Agency (EPA) implied that it may subject plant-incorporated protectants, or PIPs, to the establishment registration and facility-based production reporting requirements developed to address concerns with pesticide production. The substances used in PIPs are typically naturally occurring proteins that are only harmful to a narrow range of pests. BIO submitted comments to the EPA stating that the additional regulation would discourage innovation and could cause disruption in U.S. agriculture.

Strategy for American Innovation: BIO Comments to the U.S. Department of Commerce

Apr 1 2011
BIO submitted comments in response to the Request for Comments on the Strategy for American Innovation issued by the U.S. Department of Commerce. BIO addressed policies relating to government research and development, entrepreneurship, intellectual property, and incentives to innovate. BIO encouraged the Department of Commerce to help create an environment conducive to risk-taking and one that will unleash the tremendous potential of biotechnology.