Home » Advocacy » Letters, Testimony & Comments

Letters, Testimony & Comments

Biodefense: Pandemic Influenza and the BioShield Special Reserve Fund (SRF) in HR 4899
July 26, 2010
Members of BIO, TechNet, and NVCA commend the Senate for rejecting the rescission of $2 billion from pandemic influenza and the BioShield Special Reserve Fund (SRF) that the House included in its amendment to HR 4899, the FY2010 Supplemental...
International: National Export Initiative
July 26, 2010
Biotechnology companies would be less likely to export their products into countries that do not provide meaningful IP and data protections
NIH: Conflict of Interest Rules
July 20, 2010
BIO long has argued that actual and potential conflicts of interest in research should be identified, disclosed, and appropriately managed. BIO supports policies that emphasize disclosure of financial interests, rather than prohibiting certain...
FDA: Transparency Initiative
July 20, 2010
BIO’s comments on FDA Transparency Task Force’s Draft Proposals for Public Comment Regarding Disclosure Policies. BIO agrees that FDA should seek to make Agency activities and processes accessible to patients, physicians, health care...
NIH: Objectivity in Research for Which Public Health Funding Is Sought
July 20, 2010
BIO long has argued that actual and potential conflicts of interest in research should be identified, disclosed, and appropriately managed. BIO supports policies that emphasize disclosure of financial interests, rather than prohibiting certain...
Medicare: Medicare Coverage Gap Discount Program
July 16, 2010
BIO comments on the Medicare Coverage Gap Discount Program Draft Third Party Administrator Agreement (TPA Agreement) and the Draft Data Use Agreement released by the Centers for Medicare and Medicaid Services (CMS). BIO appreciates CMS’...
Manufacturing Practices: Revisions to Europe’s cGMP Guide
July 15, 2010
BIO submitted comments on the Annex 2, Revision 2, of the European GMP Guide: Manufacture of Biological Medicinal Products for Human Use, which extends the breadth of good manufacturing practices for medicinal products for human and veterinary to...
Comparative Effectiveness: Patient Protection and Affordable Care Act (PPACA)
July 12, 2010
BIO nominates Six Professionals to Serve as the pharmaceutical representative on the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors, established by PPACA.
Biodefense: Executive Order from President Obama Related to the Select Agents Program
July 2, 2010
Optimizing the Security of Biological Select Agents and Toxins in The United States
Genetically Engineered Plants: USDA’s APHIS Plans to Prepare an Environmental Impact Statement (EIS) in Connection with a Court-Mandated Evaluation of the potential Impacts on the Human Environment Associated with the Glyphosate-tolerant Sugarbeet Line
June 28, 2010
BIO applauds APHIS’ decision to request that EPA serve as a cooperating agency in preparing this EIS, and encourages APHIS to also use EPA’s human health risk assessment.
Biodefense: Proposed Offsets Within the FY2010 Supplemental Appropriations Act
June 24, 2010
BIO urges that funds directed for pandemic influenza and the BioShield Special Reserve Fund not be rescinded so that they are available to support developing countermeasures for the prevention and treatment of pandemics and injuries or diseases...
Advanced Biofuels: Expanding Tax Credits for Cellulosic Fuels to Algal Biofuels
June 23, 2010
A letter to the House Ways & Means Committee by 54 trade organizations and companies supporting the extension of cellulosic biofuel production tax credits eligibility to algae and other potential advanced biofuels and creating a refundable...
Medicare: Coverage Gap Discount Program Model Manufacturer Agreement
June 21, 2010
Re: Medicare Coverage Gap Discount Program Model Manufacturer Agreement – [CMS-4151-NC] RIN 0938-AQ04 Dear Administrator Tavenner: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Medicare...
Greenhouse Gas Emissions: EPA’s Tailoring Rule Regarding Who is Subject to New Source Review Requirements
June 18, 2010
Letter to the EPA Administrator from 163 organizations stating that the EPA failed to take into account that biomass recycles carbon emissions in the Title V Greenhouse Gas Tailoring Rule.
Farm Bill: Proposed Rules Should Reduce Dependence on Petroleum
June 15, 2010
BIO submitted comments on the USDA’s proposed rules for the Bioenergy Program Loan Guarantees, Repowering Assistance Program and Biorefinery Assistance Program, saying the primary purpose should be to incentive production of biofuels as a...
EPA: Greenhouse Gas ("GHG") Emissions from Biogenic Sources
June 13, 2010
Comments of Biotechnology Industry Organization on EPA’s Call for Information on Greenhouse Gas Emissions Associated with Bioenergy and Other Biogenic Sources EPA Docket No. EPA-HQ-OAR-2010-0560 September 13, 2010 The Biotechnology...
USDA: Solicitation of Input from Stakeholders Regarding Agriculture and Food Research Initiative (AFRI)
June 7, 2010
BIO supports an AFRI program that emphasizes the need for research on new, science-based agricultural technologies, including plant and animal biotechnology, which provide the means to meet the vast challenges of human health, hunger and energy...
Drug Importation: Statement of Opposition to S. 6210-A (Diaz)/A. 9207-A (Crespo) addressed to the Senate Finance Committee of New York State
June 7, 2010
Senate Finance Committee Member: On behalf of the Biotechnology Industry Organization (BIO) I am writing to state our opposition to Senate Bill 6210-A/Assembly Bill 9207-A, an initiative to permit the purchase of certain prescription medications...
Farm Bill: Biofuels Groups Urge Continued Funding for Energy Title
June 1, 2010
Dear Chairman Inouye and Ranking Member Cochran: As the Senate debates fiscal year 2011 federal funding, the undersigned organizations write to urge your full support for farm bill energy programs. In the coming months, Congress will begin...
Intellectual Property: New Mechanism for Deferring the Filing a Complete Patent Application if a Previous Provisional Patent Application was Filed and is Relied on by the Applicant
June 1, 2010
BIO questions about the utility and expected impact of the proposal, and why patent applicants should be debited with subtractions from otherwise available patent term extension.