Families USA Provides Comment on Proposed Guidance for March-In Authority

Families USA submitted comments to the National Institute of Standards and Technology (NIST), Department of Commerce, and Department of Health and Human Services on a Request from Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.

The high and rising cost of prescription drugs in the U.S. is a profound health problem and threat to the financial wellbeing of families and individuals. March-in authority is a critical tool available to the federal government in addressing these prices and protecting consumers. Recently released proposed guidance should help guide the administration in using this tool.

Families USA commented specifically on several elements in the proposed guidance, including:

• Strongly supporting the inclusion of price as a factor in march-in consideration.
• Recommending clarification on what constitutes as an “unreasonable” or “extreme, unjustified, or exploitative” price in order to support the administration in using march-in proceedings to improve access to medications in a market where prices are all ready out-of-control.
• Recommending consideration of existing market and patent abuses in the prescription drug market when addressing public utilization and utilization of inventions through march-in proceedings and the Bayh-Dole Act.
• Recommends removing language from the guidance that puts the importance of industry relationships with the administration over the impact on consumers.