Dear Members of the Therapeutic Information and Formulary Support Expert Committee:
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments to the U.S. Pharmacopeial Convention (USP) Therapeutic Information and Formulary Support Expert Committee (the “Expert Committee”) in response to the Draft Medicare Model Guidelines Version 6.0 (the “Model Guidelines”) released October 1, 2013.
BIO represents more than 1,100 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. 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.