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March 29 — Lawmakers are urging the HHS to exercise its rights to license generic versions of Astellas Pharma Inc.'s prostate cancer drug Xtandi as part of an effort to reduce the drug's price.
A group of Senate and House lawmakers led by Reps. Lloyd Doggett (D-Texas) and Peter Welch (D-Vt.), co-chairs of the Prescription Drug Taskforce, as well as Sen. Bernie Sanders (I-Vt.), March 28 sent a letter to the Health and Human Services Department and the National Institutes of Health asking that the NIH hold a public hearing to consider using its march-in rights under the Bayh-Dole Act, 35 U.S.C. §203. Under the Bayh-Dole Act, the federal agency that funded research leading to an invention can “march in” and issue patent licenses on its own—thereby ignoring exclusivity rights—if “reasonable terms are not being met’’ on drug pricing and if the agency has the intellectual property on the drug's molecule.
Xtandi was developed at the University of California, Los Angeles, through taxpayer-supported research grants from the U.S. Army and the NIH, the lawmakers said in a press release. The medication, which is sold by Japanese drugmaker Astellas Pharma, has an average wholesale price in the U.S. of more than $129,000 per year. It is sold in Japan and Sweden for $39,000 and in Canada for $30,000, they said.
“We 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 lawmakers said.
“We 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 said.
Democratic presidential candidate Sanders said in a statement that the U.S. government “should use every tool available to lower outrageously high prescription drug prices” and the NIH “has the power to stop this blatant profiteering and put the pharmaceutical industry on notice that the era of charging unconscionable prices must end.”
The letter also was signed by Sens. Al Franken (D-Minn.), Sheldon Whitehouse (D-R.I.), Amy Klobuchar (D-Minn.), Patrick Leahy (D-Vt.) and Elizabeth Warren (D-Mass.), as well as Reps. Elijah Cummings (D-Md.), Jan Schakowsky (D-Ill.), Rosa DeLauro (D-Conn.) and Mark Pocan (D-Wis.).
On March 7, Doggett also sent a letter urging the HHS to exercise its rights to license generic versions of Xtandi after it rejected a related request by House Democrats .
Doggett and 50 members of the House Affordable Drug Pricing Task Force had written HHS Secretary Sylvia M. Burwell Jan. 14, asking that the NIH use its march-in rights under the Bayh-Dole Act .
Four days later, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) petitioned the NIH and the Department of Defense to use their royalty-free rights in the patents covering Xtandi or to exercise “march-in” rights.
Tyler Marciniak, corporate affairs director of Astellas US LLC, said in a statement provided to Bloomberg BNA that the discussion of Xtandi's price in the KEI petition “fails to reflect what payers or patients actually pay for the medicine.”
Marciniak said that in 2015, “81 percent of privately insured patients paid $25 or less out of pocket per month for Xtandi and 79 percent of Medicare patients paid nothing out of pocket per month for Xtandi.”
“For eligible patients who do not have insurance or are underinsured, and have an annual adjusted household income of $100,000 or less, Astellas provides Xtandi for free under the Astellas Access Program; in 2015 over 2,000 men fighting advanced prostate cancer received Xtandi for free,” Marciniak said.
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