BIO issued a letter to Congressional Leadership, the Senate Finance Committee Chairs, and the House Ways and Means Committee Chairs calling for the extension of renewable energy tax credits slated to expire at the end of 2016. In its letter, BIO urges Congress to advance a multi-year extension of the Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, and the Alternative Fuel Vehicle Refueling Property.

Re: Docket No. FDA-2016-D-1703Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product; Draft Guidance for Industry and Food and Drug Administration Staff” (Draft Guidance).”BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related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.General CommentsBIO is supportive of FDA’s efforts to provide a practical regulatory guide for sponsors engaged in developing a therapeutic product and an accompanying IVD companion diagnostic (i.e. codevelopment).In general, the Draft Guidance is helpful in describing general principles to guide codevelopment for contemporaneous therapeutic product and device marketing authorizations, regulatory requirements, administrative and clinical trial planning/execution considerations. BIO notes, however, that this draft guidance seems to also refer to the concept of a “complementary” diagnostic in the text.  In light of FDA’s recent approval of a device that belongs to this this new category, we request that the Agency reference “complementary” devices in the current draft, clarify regulatory requirements for approval of “complementary” diagnostics by issuing guidance devoted to the topic as well as discuss appropriate regulatory principles to compare and contrast to companion diagnostics.  Furthermore, the guidance should discuss the principles and criteria for making an assessment to distinguish between companion and complementary diagnostics.  This will allow industry to weigh the evidentiary requirements and provide input to…

Re: Docket No. FDA-2016-D-1309: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; andFDA-2016-D-1267: Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidances entitled “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (503A Draft Guidance) and “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act” (503B Draft Guidance). BIO is the world's largest trade association representing 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. As articulated in previous comments and meetings, BIO strongly believes that the drug compounding provisions of the Drug Quality and Security Act (DQSA) did not alter current law with regard to biologics; therefore, there are still no applicable exemptions under the Food, Drug, and Cosmetic Act (FD&C Act) compounding provisions for entities that compound or repackage biological products. Additionally, due to special manufacturing challenges and heightened patient safety concerns, all drug products with a narrow therapeutic index should not be compounded. GENERAL COMMENTS: BIO thanks FDA for the release of the two Draft Guidances regarding…

Re: Docket No. FDA–2016–D–2268: Insanitary Conditions at Compounding Facilities; Draft Guidance for Industry; Availability Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance entitled “Insanitary Conditions at Compounding Facilities” (Draft Guidance).BIO is the world's largest trade association representing 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. GENERAL COMMENTS: BIO applauds the issuance by the FDA of this Draft Guidance as it recognizes the importance of sanitary conditions within compounding facilities. BIO also recognizes the inherent challenges that the FDA faces in regulating a safe and sterile environment for compounding as most compounding pharmacies do not register as 503B outsourcing facilities. Thus, we are pleased to see that the FDA encourages state regulators to pay close attention to the cleanliness of compounding pharmacy operations and to take action where necessary.Similarly, BIO believes that the current Draft Guidance could go even further to convey the importance of this issue with state regulatory agencies. Under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a drug is deemed to be adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.” A February 2016 report from the Pew Charitable Trusts entitled, “National Assessment of State Oversight of Sterile Drug Compounding,” highlighted significant state deficiencies regarding oversight of sanitary compounding…

The undersigned organizations support the inclusion of $3 million within the Fiscal Year 2017 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act to better inform the public about the application of biotechnology to food and agricultural production...

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.