Why the focus on intellectual property fails to address the complexities of medicinal access in IndiaStephen M. Sammut and Daniel S. LevineReleased in San Francisco, June, 2016Supported by and prepared for the Biotechnology Innovation Organization and the Association of Biotechnology Led EnterprisesThe opinions expressed in this paper are those of the authors and do not necessarily reflect the opinions of BIO and ABLE.

BIO submits comments to submits comments in response to the Notice of a Request for Information, published by the National Science and Technology Council, Science and Technology Policy Office. Comments were submitted to Food and Drug Administration Docket No. FDA-2015-N-3403; Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology.

The Biotechnology Innovation Organization along with the American Farm Bureau Federation sent a letter to the House of Representatives and Senate Appropriations Committees urging the Committees to oppose any provision related to bioengineered food labeling, including salmon labeling, that may come up for consideration during the Fiscal Year 2017 appropriations process. 

BIO submitted comments on the Institute for Clinical and Economic Review (ICER) Value Assessment Framework. Throughout the attached letter, BIO addresses issues it has raised previously with the Framework as well as responds specifically to the four major categories of issues that the Institute identified (in the order in which they were identified).