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BIO Submits Comments on Identification of Suspect Product and Notification

Aug 7 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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on the Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.”

Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products

Aug 6 2014
The undersigned national and regional biotechnology industry associations appreciate this opportunity to comment on the USPTO’s March 4 guidance for the determination of subject matter eligibility of claims relating to products and processes derived from natural sources or materials (the “Guidance”). We write to express our concern over the recent judicial and administrative expansion of nonstatutory patent law governing the patent-eligibility of certain classes of biotechnology inventions in the United States, as manifested in the PTO’s March 4 Guidance.

BIO Submits Comments to the Center for Consumer Information and Insurance Oversight Regarding the Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market

Jul 31 2014
    July 17, 2014   BY ELECTRONIC DELIVERY   Mandy Cohen, M.D., MPH Acting Director, Center for Consumer Information and Insurance Oversight Centers for Medicare and Medicaid Services Department of Health and Human Services 200 Independence Avenue SW Washington, DC 20201   Re: Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market   Dear Dr. Cohen:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the notices issued by the Center for Consumer Information and Insurance Oversight (CCIIO) on June 26, 2014, entitled “Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market (the ‘Draft Standard Notices’).”[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] Center for Consumer Information and Insurance Oversight (CCIIO), Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS), Insurance Standards Bulletin Series: Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market (2014). [2] See, e.g., Congressional Budget Office, Offsetting Effects of Prescription Drug Use on Medicare’s Spending for Medical Services (Nov. 2012).  

BIO Submits Comments on FDA's Strategic Plan, 2014-2018

Jul 30 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “The Food and Drug Administration Fiscal Year 2014-2018 Strategic Priorities.”

BIO Submits Comments on Proprietary Naming

Jul 27 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA, the Agency) for the opportunity to submit comments on the Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs.

BIO Submits Comments on Expedited Access for PMAs Intended for Unmet Medical Needs

Jul 21 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions; Draft Guidance for Industry and Food and Drug Administration Staff.”

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.”