Letters, Testimony & Comments

In response to a Request for Information (RFI) from the Senate 340B Bipartisan Working Group, BIO submitted detailed comments on the current status of the program and suggestions for improvements.

BIO submitted general comments and specific recommendations to the FDA in response to the agency's request for information. (Docket FDA-2022-D-2870)

BIO submitted comments to CMS per their Notice of Proposed Rulemaking: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program.

BIO submitted comments on the recent Rare Disease Endpoint Advancement (RDEA) Pilot Program Workshop, held June 7-8, 2023 (Docket No. FDA-2022-N-2480)

BIO provides general comments and recommendations on FDA’s Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act (Docket No. FDA-2005-D-0460-0008)

BIO provides general comments and recommendations to FDA on “Complying with the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act” (Docket No. FDA-2005-D-0460-0007)

BIO and 59 other organizations have written to House and Senate Agriculture Committee leaders to ask that they direct Congress to withdraw the current rule concerning regulation of plant incorporated protectants and replace it one based on a science…

BIO provides detailed comments to the Committee on its draft of the 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), legislation that is critical to our national health security.

BIO submitted general comments and proposed changes to FDA (Docket No. FDA-2023-D-0026)

BIO comments on U.S. Patent & Trademark Office proposed reforms to PTAB patent invalidation proceedings.