BIO's Testimony to the Senate Health, Education, Labor, and Pensions Full Committee Hearing on the FY2012 FDA User Fee Agreements

Mar 29 2012


BIO Comments to FDA on Unsolicited Requests for Off-Label Information

Mar 26 2012
Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Agency’s Draft Guidance for Industry on Responding to Unsolicited requests for Off-Label Information About Prescription Drugs and Medical Devices (Draft Guidance). This Draft Guidance, as well as FDA’s December 28, 2011 Notice; Request for Comments on Communications and Activities Related to Off-Label Uses[1]are important steps in developing policies on manufacturer communications involving off-label information. BIO is submitting separate comments to FDA addressing the Agency’s December 28, 2011 Notice and Request for Comments.  Further, BIO looks forward to additional opportunities to comment on other issues raised in the July 5, 2011 citizen petition submitted to FDA, including interactions with formulary committees, payors and similar entities, and dissemination of third-party clinical practice guidelines. [2]  

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

Mar 26 2012
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. 

Supplemental Examination: BIO Comments on Patent Reform

Mar 25 2012


BIO's Testimony to the House Appropriations, Labor HHS Subcommittee on the President's FY 2013 Budget Request for the National Institutes of Health (NIH)

Mar 20 2012


BIO Supports the JOBS Act (H.R. 3606)

Mar 16 2012
On behalf of BIO and its more than 1,100 members, Jim Greenwood submitted a letter to Senate Majority Leader Harry Reid and Minority Leader Mitch McConnell in strong support of H.R. 3606, the Jumpstart Our Business Startups (JOBS) Act.

PCORI Draft National Priorities and Research Agenda: BIO's Comments

Mar 14 2012


AIA Oath or Declaration: BIO Comments

Mar 7 2012


Spurring Job Growth Through Capital Formation While Protecting Investors

Mar 6 2012
William D. Waddill, Senior Vice President and Chief Financial Officer of OncoMed Pharmaceuticals highlights the importance of capital formation to encourage investment in the biotechnology industry and spur job growth across the country.

2013 Draft Call Letter: BIO's Comments to CMS

Mar 1 2012