The NIH has proposed requiring biopharma companies or licensees to submit plans for how patients will access drugs or devices that are developed with the help of taxpayer funding.
Tuesday’s proposal is part of a wider push from the Biden administration to lower prescription drug prices, built off the passage of the drug price negotiations in the Inflation Reduction Act, which Biden has been campaigning on. Biden previously drew bipartisan pushback for a plan to exercise the government’s so-called march-in rights when drug prices rise too high.
The NIH is seeking public feedback on the proposal, including a tiered system based on when the technology was licensed by the private sector. Licenses granted for later-stage drugs, biologics, devices and vaccines “would include more specific, tailored access oriented provisions, while licenses granted for early-stage inventions would be more flexible to reflect the higher uncertainty,” the NIH said in a Federal Register notice.
The NIH draft also seeks to balance biopharma companies’ needs, particularly as many of the companies licensing inventions from the NIH are small.
“A final policy approach should be reasonable and not seek to force licensees into access obligations that obstruct commercial development or damage the viability and sustainability of a product in the market,” the NIH wrote.
The NIH said it will provide more examples of “acceptable, commercially reasonable approaches for promoting access,” while seeking to understand how these new access plans can “incorporate transparent cost-accounting measures to assist NIH in driving down costs associated with innovation.” The agency is also seeking information on how to be flexible for licensees.