BIO Submits Comments Re: USP Drug Classification System, Second Round of Public Comments

Nov 9 2017
BIO submitted comments to the U.S. Pharmacopeial Convention (USP) Healthcare Quality and Safety Expert Committee (Expert Committee) in response to the second round of public comment on the USP Drug Classification System (USP DC), released September 25, 2017. In response to the USP DC, BIO offers comments consistent with our comprehensive comments on the draft Version 7.0 Medicare Model Guidelines (MMG) and comments on last year’s draft USP DC, both of which are included as appendices for the Expert Committee’s reference. Our comments, as follows, also correspond to the call for additional feedback on how to make the USP DC more user friendly as expressed on the open-mic web meeting.

CMC: BIO Comments on FDA Draft Guidance CMC Postapproval Manufacturing Changes for Specified Biological Products to be Documented in Annual Reports

Oct 13 2017



BIO's Letter to the Senate Committee on Judiciary Regarding Deficiencies at the USPTO

Oct 12 2017
BIO President and CEO James C. Greenwood details deficiencies at the USPTO that are undermining longstanding and carefully-balanced procedures governing market entry and patent dispute resolution under the highly successful Hatch-Waxman Act.

BIO Comments to USDA’s Office of Budget and Program Analysis on Identifying Regulatory Reform Initiatives, September 15, 2017

Sep 21 2017
United States Department of Agriculture Jamie L. Whitten Building, Room 101-A 1400 Independence Ave SW Washington DC 20250 Re: Identifying Regulatory Reform Initiatives Dear Ms. Adcock: The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the USDA’s request for information on “Identifying Regulatory Reform Initiatives,” published in the Federal Register on July 17, 2017.1 Thank you for the opportunity to provide input as the U.S. Department of Agriculture (USDA or the Agency) considers opportunities to improve customer service and remove unintended barriers to participation in its programs in ways that least interfere with its customers and allow USDA to accomplish its mission.

BIO Submits Comments Re: Medicare CY 2018 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Part B

Sep 20 2017
BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS) proposed rule regarding the calendar year (CY) 2018 Physician Fee Schedule (PFS), other revisions to Part B, and Medicare Shared Savings Program (MSSP). BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and patient access to drugs and biological. In this letter, BIO responds to CMS’s proposals in the order in which the Agency addresses each issue in the Proposed Rule, for ease of reference. However, there are several issues of particular importance to our members given the goal of ensuring patient access to necessary vaccines, treatments, and therapies.

BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule

Sep 20 2017
BIO submitted comments on the Centers for Medicare and Medicaid Services’ (CMS’s) Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Proposed Rule for calendar year (CY) 2018 (the "Proposed Rule").  BIO members are eager to improve health care through the discovery and advancement of new therapies and thus are supportive of appropriate reimbursement in our health care system both to ensure that beneficiaries have proper access to care and to encourage investment in innovation. With these goals in mind, we have evaluated each of CMS’s proposals to ensure that they support continued access to crucial treatments and therapies in the hospital outpatient setting for Medicare beneficiaries. We briefly describe our feedback on these proposals in more detail in the balance of the letter.

SB 539 complaint

Sep 1 2017

DSCSA: BIO Files Comments on FDA Product Identifier Compliance Policy

Sep 1 2017

Dear Sir/Madam:


BIO comments on EPA’s proposed rule on the Renewable Fuel Standard Program: Standards for 2018 and Biomass-Based Diesel Volume for 2019

Aug 31 2017
BIO requests that EPA revise its proposed 2018 RFS rule to build upon the successes of the 2017 RFS and send a signal that there will be market growth for advanced and cellulosic biofuels. The proposed rule in its current form puts at risk industry progress and development with a new methodology that will in effect limit the volumes for cellulosic biofuels.

BIO comments to USD-AMS on the National Bioengineered Food Disclosure Law (RE: Questions Under Consideration)

Aug 25 2017

August 25, 2017