Jim Greenwood testifies before the House Energy and Commerce Subcommittee on Health regarding the drug safety provisions of the discussion draft of the Food and Drug Administration Globalization Act. (May 1, 2008)
Read the testimony (100 KB PDF)

Reprint Practices for the Distribution of Medical Journal Articles et al. on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (April 21, 2008)
BIO's comments to the FDA
Read the letter (142 KB PDF)

BIO's Letter Supporting S.358, the Genetic Information Nondiscrimination Act (GINA) (April 15, 2008)
Letter to The Honorable Edward M. Kennedy
Read the letter (76 KB PDF)
Letter to The Honorable Olympia J. Snowe
Read the letter (76 KB PDF)

Letter Urging USDA to Issue Final Revisions to 7 CFR Part 340 by End of 2008 (April 15, 2008)
Letter to USDA Secretary Ed Shafer
Read the letter (140 KB PDF)

Steps Tricare Management Activity (TMA) has taken to implement a new rebate regime (April 10, 2008)
Comments on prescriptions filled through the Tricare Retail Pharmacy Network
Read the comments (171 KB PDF)

Ag Trade letter supporting Ellen Terpstra's nomination as Chief Ag negotiator (April 4, 2008)
Letter to Senate Finance Committee
Read the letter (86 KB PDF)

Medicare Program; Town Hall Meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) (April 3, 2008)
BIO's comments to the CMS April 30th public meeting of MedCAC
Read the comments (192 KB PDF)

Statement to the Coverage and Analysis Group of the Centers for Medicare & Medicaid Services (March 14, 2008)
BIO's comments to the CMS regarding adding compendia for the purposes of making medicare coverage determinations
Read the comments (110 KB PDF)

Proposed Revised Annex 2: Manufacture of Biological Medicinal Products for Human Use (March 14, 2008)
BIO comments to the EMEA
Read the letter (153 KB PDF)

Statement to the Advisory Panel on Ambulatory Payment Classification Groups (March 7, 2008)
BIO's testimony before the Advisory Panel on Ambulatory Payment Classifications regarding the policies the CMS has adopted and is considering adopting for drug and biological therapies.
Read the comments (216 KB)

BIO Comments to Brazilian Bill (February 28, 2008)
BIO submitted comments in response to the public consultation requested by the Office of the President, Subsector for Legal Affairs (Casa Civil da PresidÍncia da Rep˙blica, Subchefia para Assuntos JurÌdicos), regarding the draft bill of law covering the collection of biological material, access to genetic resources and their derivatives for scientific or technological research, remittance and transport of biological material, access to and protection of the associated traditional knowledge and rights of farmers and the sharing of benefits.
Read the letter (160 KB PDF)

Comments on the Identification of Countries involving the Special 301 Provisions (February 11, 2008)
BIO's letter to the Office of the U.S. Trade Representative
Read the letter (181 KB PDF)

Comments on the changes to the Hospital Outpatient Prospective Payment System (January 28, 2008)
Bio's comments on the CMS final rule regarding revisions to the hospital outpatient prospective payment system and 2008 payment rates
Read BIO's comments (214 KB PDF)

Comments on the Medicare Advantage-Prescription Drug (MA-PD), Cost-Based Plan, and Stand Alone Prescription Drug Plan (PDP) (January 30, 2008)
BIO's comment on the Centers for Medicare & Medicaid Servicesí Draft 2009 Medicare Advantage
Read the letter (190 KB PDF)

Proposed changes to the 2010 Healthcare Common Procedure Coding System (HCPCS) (December 10, 2007)
Bio's comments on proposed changes to the 2010 HCPCS Level II Modification Process
Read BIO's comments (192 KB PDF)

Comments on the treatment of prescription drugs under the Medicaid Drug Rebate Program (December 21, 2007)
A letter from BIO to the Centers for Medicare and Medicaid Services' (CMS)
Read the letter (244 KB PDF)

Comments on the USP Draft Medicare Model Guidelines Version 4.0 (December 6, 2007)
A letter from BIO to the United States Pharmacopeia regarding the USP Draft Medicare Model Guidelines
Read the letter (190 KB PDF)

Comments on the importance of NIH funding in the FY2008 LHHSE Appropriations Bill (October 25, 2007)
A letter from BIO (and other biotech leaders) to House Leaders regarding NIH Funding for FY2008
Read the letter (72 KB PDF)

Comments to the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (“IGWG”) (October 3, 2007)
BIO's comments regarding drawing up a global strategy and plan of action on public health innovation and intellectual property for developing countries.
Read the comments (312 KB PDF)

Comments regarding In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) (August 27, 2007)
BIO's letter to the FDA
Read the letter (153 KB PDF)

BIO's Statement on the Bayh-Dole Act (August 27, 2007)
BIO's statement before the House Science and Technology Subcomittee on Technology and Innovation
Read the comments (78 KB PDF)

Concerns with compliance information on China's WTO commitments (August 16, 2007)
Letter to the U.S. Council for International Business
Read the letter (288 KB PDF)

Coalition Supports Tax Legislation to Advance Renewable Energy (July 30, 2007)
A coalition of 18 renewable energy groups, including BIO, sent a letter to Senators asking them to support tax legislation that will transform the United States into a world leader in renewable and clean energy technologies.
Read the letter (71 KB PDF)
Read the press release

Comments Regarding Proposed Exemptions for Plant-Incorporated Protectants Derived from Plant Viral Coat Protein Genes (July 17, 2007)
Letter to Office of Pesticide Programs (EPA)
Read the letter (329 KB PDF)

Chemical, Biological, Radiological, and Nuclear Threats (July 13, 2007)
BIO's comments on HHS' Public Health Emergency Medical Countermeasure Implementation Plan.
Read the comments (174 KB PDF)

Comments Regarding Proposed Revisions to Regulation of Plant-Incorporated Protectants (July 13, 2007)
Letter to Office of Pesticide Programs (EPA)
Read the letter (1.16 MB PDF)

Use of Medication Guides to Distribute Drug Risk Information to Patients (July 11, 2007)
BIO's comments to the FDA.
Read the comments (33 KB PDF)

Agricultural Biotechnology in China (June 29, 2007)
ASTA and BIO Joint Letter to USDA FAS Administrator Michael Yost.
Read the letter (998 KB PDF)

Patent Law Harmonization (June 22, 2007)
BIO Letter to the Patent and Trademark Office.
Read the letter (525 KB PDF)

Food Plus Fuel, Not Food or Fuel
Myths and Facts: Food and Fuel
Learn the facts

Erythropoiesis Stimulating Agents (ESAs) (June 13, 2007)
BIO's comments regarding CMS' proposed restrictions for FDA approved uses and off-label uses.
Read BIO's comments (201 KB PDF)

Inpatient Prospective Payment System (June 12, 2007)
BIO's comments regarding CMS' proposed 2008 changes.
Read BIO's comments (232 KB PDF)