BIO Comments to FDA on Scientific Exchange related to Off-Label Information

Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or the Agency) for the opportunity to submit comments on this important topic.  The ability to exchange scientific information with healthcare practitioners and the public is absolutely essential to the activities of BIO members.  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 members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.  Given this fundamental reliance upon the flow of scientific information, our members believe it is critical for the Agency to reconsider its current approach to communications and activities related to both off-label uses of marketed drug products and uses of drug products not yet legally marketed.