Letters, Testimony & Comments

October 4, 2010
Dear Ms. Blue: This letter is submitted by the Biotechnology Industry Organization (BIO) in response to the request for public comments regarding USTR’s annual Report on Sanitary and Phytosanitary (SPS) Measures. BIO represents more than 1...
October 4, 2010
      Product Launch Stewardship Introduction Through its advocacy efforts, BIO’s Food and Agriculture Section supports a regulatory framework that facilitates and enables the development and commercialization of...
October 4, 2010
Dear Secretary Vilsack: For the past 15 years, agricultural products derived from modern biotechnology have provided significant agronomic benefits to America's farmers. From increased yields, to reducing the impact of agriculture on the...
October 1, 2010
Comments to the International Trade Administration: Vaccine production and additional planning for future possible pandemic influenza Dear Mrs. Earley, The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment the...
October 1, 2010
The Biotechnology Industry Organization (BIO) is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,100 members worldwide. Our mission is to be the champion of...
September 30, 2010
Dear Ms. Maloy, As President and CEO of the Biotechnology Industry Organization (BIO) and on behalf of our more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S....
September 29, 2010
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments on India’s Department of Industrial Policy and Promotion’s (DIPP) discussion paper on compulsory licenses published on August 24, 2010....
September 23, 2010
Re: Docket No. FDA-2010-D-0283: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes Reportable in Annual Reports; Availability Dear Sir/Madam: The Biotechnology Industry Organization (BIO)...
September 23, 2010
Re: Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals [DoD-2008-HA- 0029; 0720-AB22] Dear Captain Blanche: The Biotechnology...
September 20, 2010
Members of the Veterinary Medical Advisory Committee, My name is Dr. David Edwards, and I am the Director of Animal Biotechnology for the Biotechnology Industry Organization (BIO). We represent 1,100 member organizations that research, develop...
September 20, 2010
Dear President Obama: We are writing to ask for your support to provide additional guidance to the Department of Energy’s (DOE) Loan Guarantee Program (LGP) to unlock funding for advanced biofuels, biochemicals and bioproducts projects....
September 17, 2010
Re: Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act Please Refer to OCIIO-9992-IFC Dear Mr. Mayhew: The Biotechnology...
September 8, 2010
BIO urges the Court of Appeals for the Federal Circuit to exclude the disclosure of the patent specification to support a finding of double-patenting.
September 7, 2010
BIO suggests the proposed guidance address dose finding, additive or synergistic efficacy, additive or synergistic safety, drug interactions, special populations, unique toxicities, and study design.
August 31, 2010
BIO is pleased that CMS proposes to reimburse all separately payable drugs and biologicals at average sales price (ASP) plus six percent in 2011 and that the agency has recognized and addressed some of the problems with its rate-setting...
August 31, 2010
BIO is pleased that CMS proposes to reimburse all separately payable drugs and biologicals at average sales price (ASP) plus six percent in 2011 and that the agency has recognized and addressed some of the problems with its rate-setting...
August 30, 2010
BIO agrees that prioritizing the select agents into stratified tiers based on an assessment of relative risk would be appropriate. We feel that such an exercise would help set federal government research, development and procurement priorities....
August 25, 2010
BIO supports the draft Biennial Implementation Plan’s goal to rapidly develop and adopt countermeasures that mitigate health consequences of a chemical, biological, radiological and nuclear attack.
August 24, 2010
BIO is concerned about problems in CMS methodology that continue to create instability in reimbursement for separately payable drugs and biologicals.