Close

BIO's Comments on the Centers for Medicare and Medicaid Services' (CMS) Proposed Decision Memorandum for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer

Apr 28 2011
BIO submitted comments in support of CMS's proposed decision to preserve the ability for physicians and their patients to make the treatment determination that is optimal for their situation. BIO also highlights the potential impact of initiating on patients' access to novel, cutting-edge therapies of initiating a National Coverage Analysis (NCA) on newly-approved therapies.

BIO Statement for the Institute of Medicine Committee on Pediatric Studies Conducted under BPCA and PREA

Apr 28 2011
Dr. Ron Portman, BMS, Chair of BIO's Pediatrics Committee, presented on behalf of BIO at an Institute of Medicine (IOM) meeting on pediatric studies conducted under the Best Pharmaceuticals for Children Act and Pediatrics Research Equity Act (BPCA/PREA). Dr. Portman delivered a statement on the importance of BPCA/PREA, its value for the research and development of medicines for children, and responded to questions from the committee. This meeting was part of a series held at IOM in response to an FDA request for a study on BPCA/PREA. IOM is expected to issue a report on the findings of the committee.

BIO's Comments on the Report of the National Vaccine Advisory Committee (NVAC) Adult Immunization Working Group entitled Adult Immunization: Complex challenges and recommendations for improvement.

Apr 25 2011
BIO states that the report tackles the complex issues of adult immunization in a positive, collaborative and forward-thinking manner. However, in these comments, BIO addresses several areas where the report could place more importance.

BIO's Comments on the Centers for Medicare & Medicaid Services' (CMS) Medicare Coverage Gap Discount Program Appeals Guidance

Apr 22 2011
BIO addressed the process and bases for appeals and the implementation of the final appeals guidance.

National Institutes of Health (NIH) Uses American Recovery and Reinvestment Act (ARRA) Funding to Advance Scientific Research

Apr 19 2011

...

BIO Comments on the FDA's Draft Guidance for the Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies

Apr 19 2011
BIO recognizes the importance of appropriate consideration and use of clinical pharmacogenomic data by the FDA to ensure that this information is used appropriately to improve healthcare outcomes. BIO represents companies that are involved specifically with pharmacogenomics, therefore, welcome the opportunity to work with the FDA as the Agency develops guidance on clinical pharmacogenomic studies through all phases of product research and development.

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.