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BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports. BIO appreciates the effort to categorize listed annual reportable changes for biologics based on the associated commensurate risk, along with the annual reportable manufacturing type examples in the draft guidance. However, BIO recommends the final guidance include examples of situations where annual reportable listed changes may be better categorized by applicants as a supplement based on certain specific circumstances. BIO asks for additional clarifications to the draft guidance, including whether this draft guidance will be aligned with the final ICH Q12 guideline.

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.