Letters, Testimony & Comments

BIO and BIO members are urging lawmakers to enact a short-term extension of the MCM-PRV program while Congress is waiting to address a full reauthorization with PAHPA.

To protect patient access to critical prescription drugs, BIO has identified Part D guardrails (both MA-PD and PDP) for consideration as CMS develops guidance to plans for CY2025 and beyond.

BIO and PhRMA submitted joint comments on the U.S. Food and Drug Administration’s Information Technology Strategy (Docket No. FDA-2023-N-3636)

BIO submits comments and specific recommendations to the U.S. Food and Drug Administration on their Draft Guidance for Industry (Docket No. FDA-2023-D-2436)

On behalf of CSBA, BIO submitted this MDRP sign-on letter to CMS, which strongly urged the agency to refrain from finalizing a proposal that would drastically impact the Medicaid Best Price calculation.

BIO submitted comments to the National Institutes of Health in response to the agency's request for comment on a proposal to review NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to include specific…

In response to their request for information, BIO submitted these comments, including line-by-line recommended edits.

BIO submitted comments to DoD, GSA, and NASA on the Proposed Rule to amend and restructure regulations on environmental and sustainability procurement (FAR Case 2022-006, Docket No. 2022-0006, Sequence No. 1 RIN 9000-AO43)

Comments on Revised HSR Premerger Notification and Report Form 16 CFR Parts 801-803—Hart-Scott-Rodino Coverage, Exemption, and Transmittal Rules, Project No. P239300