By Donald Zuhn --
On March 28, 2016, a dozen members of Congress sent a letter to Sylvia Mathews Burwell, the Secretary of the Department of Health and Human Services, and Dr. Francis Collins, the Director of the National Institutes of Health (NIH), to "strongly encourage the NIH to use its [march-in] authority to hold a public hearing on the request put forth by certain public interest groups to help establish whether or not [the statutory] criteria [for the use of the NIH's march-in rights] are met in the case of Xtandi (enzalutamide)." Enzalutamide is a synthetic, non-steroidal pure antiandrogen that was developed by the pharmaceutical company Medivation for the treatment of metastatic castration-resistant prostate cancer.
The letter indicates that the drug was developed at the University of California, Los Angeles (UCLA) using taxpayer supported research grants from the U.S. Army and NIH, and that Japanese licensee Astellas currently "charg[es] Americans $129,000 for this drug, which sells in Japan and Sweden for $39,000, and in Canada for $30,000." Noting that "[t]he 1980 Bayh-Dole Act gives federal agencies, including the NIH, the authority to license a patent when 'action is necessary to alleviate health or safety needs which are not reasonably satisfied' or if the invention is not 'available to the public on reasonable terms,'" the signatories to the letter state that "[w]e do not think that charging U.S. residents more than anyone else in the world meets the obligation to make the invention available to U.S. residents on reasonable terms." The letter also notes that "despite [the Bayh-Dole Act] being in place for over 35 years, the NIH has never used this broad and powerful authority to protect consumers from excessive prescription drug prices."
According to the signatories, a "public hearing on Xtandi by the NIH would help to provide insight into NIH's decision-making process on this case," as well as allow the public "to better understand [the NIH's] position on the use of march-in to address excessive prices." The letter points out that as a result of the NIH's granting of a hearing in 2004 on Abbott Laboratories' Norvir (ritonavir), the price of ritonavir was lowered for public payors.
The letter was signed by Representatives Lloyd Doggett (D-TX), Peter Welch (D-VT), Elijah E. Cummings (D-MD), Jan Schakowsky (D-IL), Rose DeLauro (D-CT), and Mark Pocan (D-WI), and Senators Bernard Sanders (I-VT), Al Franken (D-MN), Patrick Leahy (D-VT), Sheldon Whitehouse (D-RI), Elizabeth Warren (D-MA), and Amy Klobuchar (D-MN).