Letters, Testimony & Comments

Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…

On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…

BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.

BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands. 

BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.    

The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.

In response to their advance notice of proposed rulemaking (ANPRM), BIO submitted comments to the DOJ's National Security Division on implementing the White House Executive Order of February 28, 2024, “Preventing Access to Americans’ Bulk Sensitive…

We, the undersigned, are writing to express our strong concern with a proposed update to the Medicaid Drug Rebate Program. If finalized in its current form, the proposed rule (CMS-2434-P) would impose significant costs to the government and industry…

In response to the 340B Request for Information issued by the Senate 340B Bipartisan Working Group, BIO submits detailed comments.