One year after being asked to widen access to a pricey cancer treatment by using a controversial provision of federal law, the National Institutes of Health is only now preparing to review and assess the request. And the delay is raising fresh doubts that the Biden administration will use this tactic to address the high cost of some medicines, despite being urged to do so by dozens of lawmakers.
At issue is the cost of the prostate cancer drug Xtandi, which as of this past January has a list price of $156,000, according to Elsevier Health. The medicine was developed at the University of California, Los Angeles, with help from U.S. taxpayer dollars — specifically, grants from the NIH and the Department of Defense. One of the chief inventors was a professor at UCLA, which licensed the drug to a biotech that later struck a marketing deal with Astellas.
With backing from patient and consumer advocacy groups, two cancer patients petitioned the NIH last year and asked agency officials to effectively sidestep the patents by using so-called march-in rights. Under a federal law known as the Bayh-Dole Act, a government agency that funds private research can require a company to license its patent to another party in order to “alleviate health and safety needs, which are not being reasonably satisfied.” An agency can also do so when the benefits of a product are not available on “reasonable terms.”
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