US refuses to compel lower prices for Pfizer and Astellas cancer drug
NIH rejects petition to use “march-in” rights to allow cheaper competition | Xtandi is “widely available” to public, federal agency says.
The US National Institutes of Health (NIH) has rejected calls to exercise “march-in” rights that would lower the price of prostate cancer drug Xtandi, made by Pfizer and Astellas, by expanding competition.
In a letter dated Tuesday, March 21, the NIH responded to a petition from several US senators and organisations requesting the government use the march-in authority under the Bayh-Dole Act (35 USC §203) to lower the price of Xtandi (enzalutamide).
March-in rights enable the government to grant patent licenses to third parties for products developed using federal funds, if the patent holder does not make them available to the public on reasonable terms. The mechanism has never been used in practice.
US senators Elizabeth Warren and Angus King, and congressman Lloyd Doggett, threw their support behind the campaign to allow cheaper competition to the cancer drug, pointing out that it “can cost Americans as much as six times what it costs individuals in other high-income countries”, Fierce Pharma reported.
NGO Knowledge Ecology International, which campaigns for social justice regarding knowledge resources, and Universities Allied for Essential Medicines, a student-led organisation working to improve access to medicines, also joined the petition.
‘Widely available’
In its response, the NIH said it shared concerns about the high price of drugs and burden that places on patients, with nearly a quarter of Americans struggling to afford prescription drugs.
However, it found Xtandi to be widely available to the public on the market, and said that given the remaining patent life and lengthy administrative process involved in a march-in proceeding, it did not believe that the march-in authority would be effective in lowering the price of the drug.
The decision was consistent with the NIH’s findings in 2016, when patient group the Union for Affordable Cancer Treatment pressed the NIH to exercise march-in rights for Xtandi and the request was rejected.
Japanese multinational pharma firm Astellas said the decision would protect public-private partnerships as “incubators of technological innovation”, Reuters reported.
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox
