BIO Applauds Reps. Sinema and Fitzpatrick for Introducing the Fostering Innovation Act

Bill would extend a cost-saving JOBS Act provision

BIO Statement on Hepatitis C Medicines Report from Senators Grassley and Wyden

Washington, D.C. (December 1, 2015) – The following statement regarding the report released today by Senators Grassley and Wyden may be attributed to BIO Senior Vice President of...

BIO Statement on EPA Final Rule for 2014, 2015 and 2016 Renewable Fuel Standards

The final rule for the 2014, 2015 and 2016 Renewable Fuel Standards (RFS), issued today by the Environmental Protection Agency (EPA), is an unnecessary, unlawful about face for a program that was successfully driving development of cleaner biofuel technologies and reduction of U.S. greenhouse gas emissions. The rule undermines the goals of the statute, and it will continue to undercut investment in advanced and cellulosic biofuels and increase greenhouse gas emissions in the transportation fuel sector, BIO said today.

Quality Metrics: BIO Comments on FDA Draft Guidance Request for Quality Metrics

In general, BIO is supportive of FDA’s effort to modernize regulatory oversight of drug quality and promotion of post-approval improvements, and of FDA’s quality metrics initiative overall. Assessing across organizations, programs, products, and processes can be a considerable challenge, and many factors, including where a particular product is in its lifecycle, may influence some measures. As a result, BIO is supportive of FDA’s intent to use the quality metrics gathered as a tool and in context with other sources of quality data and not as the sole way for FDA to determine the state of quality within sites or products. It would be helpful for FDA to more clearly state the intended use of the collected metrics and the benefits to industry. We understand that regulatory relief (e.g., less frequent inspections, post-approval manufacturing change categories) may be granted based on positive high-quality metrics; however, it is unclear whether FDA would use low-quality metrics as an indicator to increase inspections at a particular entity. We believe metrics can provide a valuable tool to quantify product quality and can assist the Agency in developing a risk-based inspection program. It will be important to view these metrics in their proper context and in the broader set of information and knowledge FDA possesses. BIO recommends that FDA clarify that the quality metrics data will be used as an input to the risk-based inspection model and for surveillance purposes only; FDA will not take compliance actions solely based on quality metrics data evaluation. In addition, BIO requests that clarity be provided regarding the extent to which CBER will implement this new approach for facilities it inspects.

BIO Applauds Administration’s Support for Science-based Food Policy

The Food and Drug Administration (FDA) has officially announced that it has rejected petitions from public interest groups calling for mandatory labeling of foods produced with genetic engineering.

BIO Statement on HHS Forum on Pharmaceutical Innovation, Access, Affordability and Better Health

Washington, D.C. (November 20, 2015) – The Biotechnology Industry Organization (BIO) released the following statement regarding today’s U.S. Department of Health and Human Services...

BIO Submits Comments on the Establishment of CDRH PEAC

The Biotechnology Industry Organization (BIO) thanks the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) for the opportunity to submit comments to the public docket entitled Establishment of the Patient Engagement Advisory Committee; Establishment of a Public Docket; Request for Comments1 (the “Public Docket”).

BIO Applauds FDA Approval of GE Salmon, Technology Provides Sustainable, Nutritious Food

After conducting a thorough and rigorous regulatory review, the U.S. Food and Drug Administration (FDA) has approved the genetically engineered (GE) AquAdvantage® Salmon for commercial marketing.

BIO Releases Seven Proposed Topics for HHS Forum on Pharmaceutical Innovation, Access, Affordability and Better Health

BIO released a list of seven proposed topics for the November 20th U.S. Department of Health and Human Services (HHS) Forum on Pharmaceutical Innovation, Access, Affordability and Better Health. The consideration of these topics at the Forum will help to ensure that patients have access to the most innovative new treatments and cures.

Michigan Senator Debbie Stabenow Introduces Legislation That Advances Tax Incentives for Producers of Renewable Chemicals

The Biotechnology Industry Organization (BIO) today thanked Senators Stabenow (D-MI), Coons (D-DE) and Franken (D-MN) for introducing S. 2271, the Renewable Chemicals Act of 2015, a bill to amend the Internal Revenue Code of 1986 to provide credits for the production of renewable chemicals and investments in renewable chemical production facilities.