Letters, Testimony & Comments

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...
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...
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...
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’...
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...
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.
July 2, 2010
Optimizing the Security of Biological Select Agents and Toxins in The United States
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.
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BIO urges that funds directed for pandemic influenza and the BioShield Special Reserve Fund not be rescinded so that they are available to support developing countermeasures for the prevention and treatment of pandemics and injuries or diseases...
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...
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...
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.
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...
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...
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...
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...
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...
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.
May 31, 2010
Re: FDA–2010– N–0218: Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare Diseases; Public Hearing Dear Sir/Madam: The Biotechnology Industry Organization (BIO)...