DAVE KOLBE CONSULTING

PROFITS OVER PATIENTS: THE PBM BUSINESS MODEL UNDER SCRUTINY" - Support comprehensive reform that addresses the entire healthcare supply chain. PBM practices drive up out-of-pocket costs for union members and working families. 340B In Managing Healthcare Costs for Taft-Hartley Plans - Federal reforms would ensure the 340B program supports patient care without shifting costs on multi=employer health plans. Pending legislation would tighten rules on outpatient versus inpatient pricing, limit certain administrative costs, increase transparency, and add new requirements for 340B hospitals. S. 2658 Medication Affordability and Patent Integrity Act - Opposition to S. 2658 as there is no evidence of a systemic issue needing to be addressed by enacting such burdensome requirements for innovator companies, as well as for the USPTO. S.2305 Biosimilar Red Tape Elimination Act - Opposing S. 2305 as the bill is unnecessary. FDA already has the authority to approve biosimilar interchangeability without requiring switching studies and is exercising that authority in recently approved interchangeable biosimilars. Eliminating these standards will do nothing to improve patient access to biosimilars if they are excluded from coverage by PBMs and Health plans. S. 3014 Ensuring Timely Access to Generics Act of 2025 - Opposing S. 3014 as it would amend Section 505(q) of the FDCA to grant FDA authority to summarily deny 505(q) citizen petitions (about approval of generics, biosimilars, and 505(b)(2) applications) if the Agency determines either that the petition was submitted with the primary purpose of delay or does not on its face raise valid scientific or regulatory issues. The bill is unnecessary given FDA's existing authorities as well as FDA guidance.