Close

BIO Applauds Creation of FDA Opioid Policy Steering Committee

Washington, DC (May 24, 2017) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement regarding the announced creation of an Opioid Policy Steering Committee at the Food and Drug Administration (FDA):

Astellas Expands Advocacy Engagement with Focused Outreach

BIO Statement on President’s Proposed 2018 Budget

Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement in response to President Trump’s FY 2018 budget proposal.

Biotech Industry Continues Strong Growth in 2016; San Diego Setting Pace for State, Nation

Mayor Faulconer, Industry Leaders Reveal Latest Data, Including Major Economic Benefits of June BIO 2017 Convention

BIO Joins Diverse Coalition Promoting Market-Based Solutions to Address Prescription Drug Costs, Increase Patient Access and Choice

Washington, DC (May 17, 2017) – Today, the Biotechnology Innovation Organization (BIO) joins with a diverse coalition of stakeholders in endorsing a set of pro-competition,...

BIO Submits Comments Re: 340 B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (CMP) Regulation Interim Final Rule

BIO submitted comments in response to the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation Interim Final Rule (the "Interim Final Rule") published in the Federeal Register on March 20, 2017. In the balance of this letter, we discuss each of our concerns in detail, focusing on the need to delay the effective date of the Final Rule until HRSA can complete revisions to the Final Rule through notice-and-comment rulemaking that address: The significant burden of the “penny pricing” policy finalized in the Final Rule; The need to revise the regulatory definition of the “knowing and intentional” standard to comply with its statutory intent; and The need to revise the treatment of ceiling price calculations for newlylaunched drugs and the definition of “instances of overcharging” to mitigate the significant and undue burden these Final Rule provisions place on manufacturers.  

BIO Submits Comments to EPA Regulatory Reform Task Force

BIO submitted comments to the Environmental Protection Agency’s Regulatory Reform Task Force on Executive Order 13777 “Enforcing the Regulatory Reform Agenda.”

BIO Comment on Executive Order 13777, Enforcing the Regulatory Reform Agenda

The Biotechnology Innovation Organization’s (“BIO”) Industrial and Environmental Section (“IES”) is pleased to provide the U.S. Environmental Protection Agency (“EPA”) input to inform its Task Force evaluation of existing regulations under Executive Order 13777, “Enforcing the Regulatory Reform Agenda.”

BIO Statement on the Passing of Biotechnology Giant Henri Termeer

Termeer was a key architect in the founding of BIO, a mentor to countless entrepreneurs, executives and researchers, and passionate in his pursuit of innovative patient...

BIO Statement on U.S.-China Comprehensive Economic Dialogue

Washington, D.C. (May 12, 2017) – The Biotechnology Innovation Organization (BIO) issued the following statement regarding initial results of the 100-Day Action Plan of the U.S.-China Comprehensive Economic Dialogue: