Document Type

Response or Comment

Publication Date

7-22-2024

Abstract

We commend the NIH initiative to require that licensees of technologies that enable discovery or development of FDA-approved products arising from the NIH intramural program to include an Access Plan to promote “product affordability, availability, acceptability, and sustainability” and recognition that such protections are essential to ensuring a “return on taxpayers' investment in biomedical research.” Recognizing the complexity of anticipating appropriate terms for products that are in pre-clinical or early clinical development at the time of licensing, we also support the proposal that the Access Plan be submitted in late-stage clinical development, though we argue that the start of pivotal clinical trials is too early and that the Access Plan should be submitted together with the NDA, ANDA, or BLA application for the first, as well as any subsequent, FDA approvals. We further argue that Access Plan should meet a reasonableness standard involving negotiation guided by symmetrical information in which both parties represent their broad interests based on the scope of their investment and their expectations for return on this investment. Finally, we provide preliminary estimates of the taxpayer’ investment in products that have been subject to NIH licenses, the NIH investment cost, and cost savings this spending provides to the licensees.

Download

Share

COinS