News

Get the latest on BIO's announcements, positions and views on everything from healthcare to biofuels. 

Press Releases
BIO Statement on Proposed Rule to Implement…
WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement on the proposed Outbound Investment Security Program (OISP) rule:"The Administration is correct that…
BIO Statement on the FDA’s ‘Fit-for-Purpose Rare…
WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement on the FDA’s ‘Fit-for-Purpose Rare Disease Framework Initiative.’“Today’s announcement is an important step…
BIO Statement on Finalization of the Globe Model
WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement on the finalization of the GLOBE model.“Biotechnology is one of America's greatest strengths, delivering…
Letters, Testimony, & Comments
BIO Comment Letter – FDA-2026-D-1257 – Leveraging…
BIO Comment Letter – FDA-2026-D-1255 – Safety…
BIO Comment Letter – FDA-2026-N-2366 – CNPV Pilot…
Amicus Briefs
BIO Files Amicus Brief in Case Addressing Anti…
BIO filed an amicus brief in the U.S. Court of Appeals for the District of Columbia Circuit, seeking the reversal of a lower court decision that found plaintiff Vertex Pharmaceuticals’ patient assistance program in violation of the Anti-Kickback…
BIO Files Amicus Brief in Delaware Supreme Court…
BIO filed an amicus brief in the Supreme Court of the State of Delaware, urging the Court to exclude Plaintiffs’ expert opinion, thereby ensuring that Delaware’s standard for the admission of such evidence remains consistent with the federal …
BIO Files Amicus Briefs Supporting the Lawfulness…
On February 10, 2025, BIO filed an amicus brief in the U.S. District Court for the District of Columbia, supporting the lawfulness of plaintiff Eli Lilly's proposed 340B rebate model. The 340B Drug Pricing Program ("340B"), through which Medicaid…