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BIO Submits comments to the Energy & Commerce Subcommittee on Commerce, Manufacturing, and Trade

Jul 14 2014
Dear Chairman Terry and Ranking Member Schakowsky: On behalf of the Biotechnology Industry Organization (BIO), I write in support of H.R. ___, the Targeting Rogue and Opaque Letters (TROL) Act of 2014, and urge the Subcommittee to pass this legislation. It is critical that legislation that seeks to reign in abuses by patent trolls does so in a way that preserves and enhances the incentives necessary to sustain our nation’s global leadership in biotechnology innovation and to spur the creation of high-wage, high-value jobs throughout the country. Improving our patent system can help America retain its global competitive advantage in biotechnology and other innovative industries, and will spur more investment and job creation at a time when both are sorely needed. We commend Chairman Terry and Members of the Subcommittee on Commerce, Manufacturing, and Trade for creating a balanced approach that will address the issue of false or deceptive patent demand letters without impeding the ability of legitimate patent owners to enforce their patents by sending patent-related communications made in good faith.

BIO Submits Comments on Allowable Excess Volume and Labeled Vial Fill Size in Injectibles

Jun 11 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.”

BIO Submits Comments to the Departments of Labor, Treasury, and Health and Human Services on the Request for Information Regarding Provider Nondiscrimination

Jun 11 2014
  June 10, 2014   Jacob J. Lew Secretary, Department of the Treasury 1500 Pennsylvania Avenue, NW Washington, D.C. 20220                               Thomas E. Perez Secretary, Department of Labor Frances Perkins Building, 200 Constitution Ave., NW, Washington, DC 20210   Sylvia Mathews Burwell Secretary, Department of Health and Human Services 200 Independence Avenue, SW Washington, DC 20201   Re: Request for Information Regarding Provider Nondiscrimination   Dear Secretaries Lew, Perez, and Burwell:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the “Request for Information Regarding Provider Nondiscrimination” (the “RFI”) issued by the Departments of Treasury, Labor, and Health and Human Services (“the Departments”) on March 12, 2014.[1]   BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO's members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced health care expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. [1] 79 Fed. Reg. 14,052 (March 12, 2014).  

BIO Submits Comments on Meetings With Office of Orphan Product Development

Jun 8 2014
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the draft guidance issued by the Food and Drug Administration (FDA) on April 9, 2014, entitled “Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff: Meetings with the Office of Orphan Products Development.”

BIO Submits Comments to the Centers for Medicare and Medicaid Services (CMS) Regarding the Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond; Proposed Rule (CMS-9949-P)

May 30 2014
April 10, 2014   BY ELECTRONIC DELIVERY   Marilyn B. Tavenner Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC 20201   Re: Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond; Proposed Rule (CMS-9949-P)   Dear Administrator Tavenner:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the proposed rule issued by the Centers for Medicare & Medicaid Services (CMS) on March 21, 2014, entitled “Exchange and Insurance Market Standards for 2015 and Beyond” (the “Proposed Rule”).[1]   BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO's members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.[2] [1] 79 Fed. Reg. 15,808 (March 21, 2014). [2] See, e.g., Congressional Budget Office, Offsetting Effects of Prescription Drug Use on Medicare’s Spending for Medical Services (Nov. 2012), available at: http://www.cbo.gov/sites/default/files/cbofiles/attachments/43741-MedicalOffsets-11-29-12.pdf.   

BIO Submits Comments on Draft Accelerated Approval Labeling Guidance

May 26 2014
 The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.

TESTIMONY OF SARA RADCLIFFE ON BEHALF OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE U.S. HOUSE OF REPRESENTATIVES ENERGY AND COMMERCE SUBCOMMITTEE ON HEALTH HEARING

May 20 2014
The importance of supporting biomedical research and innovation and the development of new therapies cannot be overstated. Today, we face increasing competition around the globe to overtake U.S. world leadership in biomedical innovation. Even in this time of budgetary constraint, it is crucial that we not allow this to happen. We cannot afford to lose the next generation of discoveries that address one of the nation’s leading cost drivers – chronic and debilitating disease.

BIO Submits Comments on Draft Analytical Procedures and Methods Validation Guidance

May 19 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Analytical Procedures and Methods Validation for Drugs and Biologics.”

BIO Submits Comments on FDA's Action Plan for Collection, Analysis, and Availability of Subgroup Data

May 15 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Action Plan for the Collection, Analysis, and Availability of Demographic Subgroup Data in Applications for Approval of Food and Drug Administration-Regulated Medical Products; Notice of Public Hearing; Request for Comments.” BIO shares the Agency’s commitment to better engage populations traditionally under-represented in clinical studies, while maintaining a focus on speeding safe and effective medicines to patients in need.

BIO and the Advanced Ethanol Council Send Letter to White House RE:Maintaining the Methodological Integrity of the RFS

May 15 2014
On May 15, 2014, the Biotechnology Industry Organization (BIO), the Advanced Ethanol Council, and associated signatories sent a letter to the White House expressing concern about the Administration’s impending decision around the Renewable Fuel Standard (RFS).