By Donald Zuhn --
In a letter sent earlier this month to Secretary Sylvia Mathews Burwell of the U.S. Department of Health & Human Services and Director Francis S. Collins of the National Institutes of Health, fifty members of the U.S. House of Representatives urged Secretary Burwell and Director Collins to use their existing statutory authority to respond to the soaring cost of pharmaceuticals.
The letter begins by noting that the Bayh-Dole Act authorizes federal agencies that fund private research to retain certain rights in patented inventions, including march-in rights under 35 U.S.C. § 203(a)(2) that can be used when the benefits of patented products are not available to the public on reasonable terms. The letter then notes that the NIH "has not previously offered official guidance regarding the situations in which march-in rights would apply," asserts that "reasonable guidelines can discourage drug price gouging," and "urge[s] NIH to issue guidelines to accomplish this goal." While acknowledging that the NIH has "appropriately referred to march-in rights as an 'extraordinary remedy'," the Representatives argue that "too many families and providers are facing an extraordinary challenge from unreasonably priced pharmaceuticals."
The Representatives express confidence in the NIH's ability to craft reasonable guidance that would "address price gouging while ensuring that march-in rights are exercised with transparency and fairness." The signatories also suggest that because such rights "would only be used when wrongdoing occurs, innovation should not be threatened," and argue that "[e]stablishing strong guidelines [would] protect consumers while reducing the need for having to actually exercise 'march-in' rights."
The Representatives also take the NIH to task for declining to exercise march-in rights in the past while suggesting that controlling drug costs is a legislative duty. Although the letter does not dispute the accuracy of such a suggestion, the Representatives counter that "Congress legislated long ago on a bipartisan basis in delegating authority to federal agencies such as NIH the responsibility to address one aspect of this problem," and declare that "[w]e call upon you to do that job."
The Representatives also note that despite some estimates that a quarter of all priority-reviewed drugs might be impacted by the NIH exercising its march-in rights, "we believe that just the announcement of reasonable guidelines in response to price gouging would positively influence pricing across the pharmaceutical industry." The Representatives conclude the letter by requesting the NIH's "prompt response in bringing relief for struggling patients and families."