Update: Video recording of the press briefing available here: https://www.youtube.com/watch?v=KwqUl7NLMXo)
December 15th 10AM – Briefing on Xtandi March-in Request
Supporters of the march-in petition to lower the cost of the prostate cancer drug Xtandi will host a virtual press conference on Wednesday December 15, 2021, to discuss the latest steps taken to advance the request, and hear from the petitioners and supporters of the request. Speakers will be available to answer questions at the close of the conference.
DATE: Wednesday December 15, 2021
TIME: 10:00am ET
LOCATION: Via Zoom – Send a note to Claire.Cassedy[at]keionline.org to receive a link or the details to join in by phone.
Note: This briefing will be recorded.
Background Materials
Pending Petitions sent to DoD and HHS on patents on Xtandi:
https://drive.google.com/drive/folders/1AgnxZYN7WpoiEkCZW4YCiGcbk9WcZIAc?usp=sharing
Overview of earlier Xtandi march-in efforts: https://www.keionline.org/xtandi
Timeline of developments regarding march-in requests: https://www.keionline.org/march-in-rights-timeline
At Issue in the Request:
Should the Biden Administration grant a march-in request for the patents on the prostate drug Xtandi, which was invented and entered clinical trials supported by funding from the US Army and the NIH, when the price of Xtandi in the United States is more than $156,000 per year, a price that is 3 to 5 times higher than it is in any other high income country?
Quotes from the Speakers:
Robert Sachs, Xtandi Petitioner
“Xtandi is a life saving drug for many men battling advanced prostate cancer. Having to deal with all the ramifications of prostate cancer is difficult enough without having to contend with price gouging by drug companies. It adds insult to injury to know that Xtandi was developed with taxpayer dollars that I and others contending with prostate cancer have paid. All we’re asking HHS to do is conduct an administrative hearing on the record to determine whether or not the price Japanese drug maker charges prostate cancer patients in the US can be justified in light of the fact that Astellas charges one-fifth the price for this life saving drug in Japan and a small fraction of the price in other wealthy countries. The 1980 Bayh-Dole Act requires that inventions funded by US taxpayers be made available “on reasonable terms.”
We’re simply asking HHS to enforce a law that has been on the books for four decades. Secretary Becerra recognized the legal use of march-in rights when he, as Attorney General of California, led a group of attorneys general who petitioned the former Administration to assert march-in rights over Remdesivir. We’re now asking HHS to exercise the administrative power that Secretary Becerra recognized in 2020 when he petitioned the U.S. Government. No new federal legislation is required for the Biden Administration to exercise march-in rights now.
Exercise of march-in rights in the case of Xtandi would not only benefit prostate cancer patients but other US citizens facing serious diseases necessitating treatment with over-priced drugs that their tax dollars have helped develop.”
Eric Sawyer, Xtandi Petitioner
“Prostate cancer is the opposite of a rare disease. U.S. residents should not be victims of discriminatory price gouging for this cancer drug. If anything, the drug should be cheaper in the United States than elsewhere, not more expensive, since it was invented on taxpayer funds. This is not a complicated march-in case. HHS will either endorse discriminatory price gouging against US residents for this taxpayer-funded cancer drug, or reject discriminatory price gouging against US residents for this taxpayer-funded cancer drug.”
Peter Maybarkuk, Access to Medicines Director, Public Citizen
“Build Back Better will lower drug prices, but not for several years, and it won’t change the monopoly problem that makes prices high. Patients need relief now and HHS has the authority to give it to them. Xtandi is a clear case for authorizing generic competition through march-in rights. A hearing would signal to drug corporations that there are limits to their monopoly power.”
Alex Lawson, Executive Director, Social Security Works
“Xtandi is the perfect case to illustrate just how badly the American people are being ripped off, with deadly consequences. Even though the drug was developed with taxpayer dollars, Americans are denied the drug because of the outrageously high price. A price that is charged in the United States alone. The government has the authority to allow generic competition in order to end the price gouging. President Biden must do so immediately.”
James Love, Knowledge Ecology International
“The Biden Administration has issued an Executive Order on Competition and an HHS report on drug pricing that state that the reasonableness of prices on drugs with federal rights in the patented inventions will be grounds for a march-in request. This is such a request. The Bayh-Dole Coalition, which represents drug companies and patent holding research institutions, does not want the federal government to enforce the requirement that inventions be available to the public on reasonable terms. This petition is a test of that issue. This is an action that can be taken now to lower the price of a drug, without new legislation or regulations. Given all of the campaigns that promise to do something about drug pricing, this is a here and now opportunity to actually do something concrete and meaningful. A failure to act will send the wrong signal on pricing of government-funded drugs, and encourage even more aggressive price gouging resulting in negative impacts on US residents regarding access, affordability and fiscal toxicity.”
About the Speakers:
Robert Sachs, Xtandi Petitioner:
Robert Sachs, 73, has been battling advanced prostate cancer for six and a half years. He is also a 36-year non-Hodgkins lymphoma survivor. An attorney by background, Mr. Sachs served in various leadership positions in the cable TV and telecommunications industries for almost four decades. In 1998 he co-founded Continental Consulting Group, a Boston-based cable and telecommunications consulting firm. From 1999 until 2005 he served as President and CEO of the National Cable & Telecommunications Association (NCTA) the major trade association representing the U.S. cable industry. Prior to that he served in various executive capacities with Continental Cablevision (now part of Comcast) for nearly 20 years. Mr. Sachs has been a governing trustee of Dana-Farber Cancer Institute since 1998. He is also a former board member and chair of the National Coalition for Cancer Survivorship (NCCS), a patient advocacy organization. Mr. Sachs holds a Bachelor of Arts in political science from the University of Rochester, a Master of Science in journalism from Columbia University, and a Juris Doctor from Georgetown University.
Peter Maybarduk, Public Citizen:
Peter Maybarduk directs Public Citizen’s access to medicines group, which helps partners worldwide make medicine available and affordable for all. The group’s work has shaped legislation and executive action in the United States and abroad and changed the course of international trade negotiations. Maybarduk and his colleagues help organize the global movement for COVID vaccine access and have rallied support to expand vaccine manufacturing and technology transfer to developing countries.
Alex Lawson, Social Security Works:
Alex Lawson is the Executive Director of Social Security Works, the convening member of the Strengthen Social Security Coalition— a coalition made up of over 340 national and state organizations representing over 50 million Americans. Lawson previously served as the Communications Director for the organization. In his current role, he coordinates the multifaceted education and advocacy operations to protect and improve the economic security of disadvantaged and at-risk populations while maintaining Social Security as a vehicle of social justice.
Eric Sawyer, Xtandi Petitioner
Until 2017, Eric Sawyer worked as Civil Society Partnership Advisor at UNAIDS, the primary policy and programmatic secretariat for the United Nations’ HIV programs. Sawyer is a long time AIDS activist who co-founded ACT UP (AIDS Coalition to Unleash Power) in New York in 1987. He also helped found Housing Works, which houses homeless people with AIDS, and Health GAP (Health Global Access Program), which centers its advocacy around HIV drugs and the access to essential medicines. He studied at the State University of New York at Oneonta and earned a graduate degree from the University of Colorado-Boulder.
James Love, Knowledge Ecology International:
James Love is Director of Knowledge Ecology International. His training is in economics and finance, and work focuses on the production, management and access to knowledge resources, as well as aspects of competition policy. The current focus is on the financing of research and development, intellectual property rights, prices for and access to new drugs, vaccines and other medical technologies, as well as related topics for other knowledge goods, including data, software, other information protected by copyright or related rights, and proposals to expand the production of knowledge as a public good. James Love holds a Masters of Public Administration from Harvard University’s Kennedy School of Government and a Masters in Public Affairs from Princeton’s Woodrow Wilson School of Public and International Affairs.