A multibillion-dollar prostate cancer medication produced by a San Francisco biotechnology firm is at the focus of a bid to convince the federal government to use its "right of entry" to cut the drug's price.
Dr. Charles Sawyers of the University of California, Los Angeles, received funding from the Department of Defense and the National Institutes of Health for early research on the $156,000-a-year medicine known as Xtandi or enzalutamide. Cancer survivors who have petitioned the federal agency argue that it is because of their support that the government is able to transfer rights to generic medicine companies, allowing Medicare to offer it for less than $4,400 per patient per year.
Xtandi was sold by Astellas Pharma Inc. of Japan, which reached a partnership with Medivation Inc. of San Francisco in 2009 to commercialize the medicine. Pfizer Inc (NYSE: PFE) bought medivation for $14 billion in 2016, with Xtandi at the focus of the purchase. The crux of the matter.
The early days of the pandemic were put to the test for the Biden administration, which campaigned to lower prescription drug prices, and Health and Human Services Secretary Xavier Becerra, who supported the use of march rights to speed up production of the Covid-19 drug raltegravir, which is based at Gilead Sciences, in Foster City.
If the petition filed at the National Institutes of Health (NIH) at the Department of Health and Human Services is approved, supporters of the pharmaceutical company say it could overturn the 42-year-old Baidoo Act, which has helped move potential drugs and new technologies from academic labs to patients and other consumers.
"People won't commit a lot of time, money, and capital if it appears like the rug might be yanked out from under them," said Joe Allen, executive director of the Bayh-Dole Coalition. Pharmaceutical companies, academic institutions, and venture investors all support the partnership.
Senators Birch Bayh and Bob Dole, who crafted the far-reaching bipartisan patent and trademark law in 1980, are honored by the group's name. At the time, Allen was a member of Bayh's staff. The alliance, however, was only created in 2021, while its predecessor group, Bayh-Dole 40, was founded in 2020.
"Bayh and Dole were at odds," Allen explained. "However, they believe that government research that is not marketed does not benefit taxpayers financially."
Access rights are granted under particular circumstances, according to Allen, such as if the corporation holding the rights to the innovation is unable to satisfy the needs of a public health emergency, comply with federal regulations, or fulfill its promise to manufacture the product in the United States. However, only a few applications have been filed.
Advocates for reduced medication pricing, according to Allen, are subverting the intent of the Bayh-Dole bill's freedom to march.
"I have a lot of sympathy for folks who can't afford their medications, and I'm not advocating for high costs," he said, "but Bayh-Dole isn't about drug price management." "You can't suddenly give a statute that's been in effect for 40 years a new meaning."
According to consumer groups, the federal government might use Bayh-Dole to provide drug rights to a firm that could save money.
Xtandi is marketed by Astellas Pharma Inc. of Japan, which entered a deal with Medivation Inc. of San Francisco in 2009 to commercialize the medicine. Pfizer Inc. (NYSE: PFE) bought Medivation for $14 billion in 2016, with Xtandi as the cornerstone of the purchase.
The petition was turned down by the agencies.
Public Citizen allegedly urged Becerra earlier this year to add low-cost versions of six more treatments, including insulin, HIV, asthma, and hepatitis C drugs, in addition to Xtandi.
Clare Love, a prostate cancer patient in Hoquiam, Washington, and Robert Sachs of Boston are waiting for the Department of Health and Human Services to say whether their Xtandi petition may advance in the current instance, which was filed in November.
They claim that a Canadian generic medication producer can create Xtandi for less than $4,400 per year in their petition.
"It is our belief that HHS is now willing to assess the merits of an entrance request when the price is manifestly exorbitant," they stated in their petition.
The NIH has not yet evaluated the petition, according to Sachs, who told the San Francisco Business Times in an email on Thursday. A petition filed with the Department of Defense in 2019 under Trump's presidency has likewise gone unanswered.
"It's difficult to reconcile the Biden administration's various statements about addressing excessive drug prices, including giving the march-in petition 'due consideration,' with the NIH's apparent failure to even make a threshold determination that the information submitted'may warrant the exercise of the right to march in,' " Sachs wrote to NIH Acting Principal Deputy Director Tara Schweitz in a letter dated Wednesday.
Since Collins, the veteran director, stepped down last December, the NIH has been without a permanent director.
The patent on Xtandi is due to expire in 2026, which means generic drugmakers might gain a head start on a medicine with annual sales of more than $4 billion.