Today, KEI submitted written testimony on SB 793 — a bill that is designed to allow the Oregon Department of Consumer and Business Services to investigate price increases for prescription drugs — in advance of a hearing before the Oregon Senate Committee on Health Care at 1:00 P.M. (PST) on March 9, 2017.
Wednesday, March 8, 2017, the Office of the United States Trade Representative (USTR) will hold the first Special 301 Hearing of the Trump administration. This year, USTR received 63 submissions in advance fo the hearing from governments, civil society organizations, and industry groups.
This blog post pulls out interesting selections from the various submissions, and includes as attachments the submissions of selected organizations.
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Email records and memoranda released by the Centers for Disease Control (CDC) in response to a Knowledge Ecology International Freedom of Information Act (FOIA) request show that representatives of the World Health Organization (WHO) and the United States government opposed including India’s proposed agenda item on the United Nations Secretary-General’s High-Level Panel on Access to Medicines for discussion at the 140th WHO Executive Board meeting.
The full set of documents, which was released to KEI without redaction, are available here:
At 11:06 P.M. on January 11, 2017, during the so-called “Vote-A-Rama”, the Senate considered an amendment put forward by Sen. Amy Klobuchar, D-Minn., and co-sponsored by Sen. Bernie Sanders, I-Vt., on the parallel importation of prescription drugs from Canada. Continue Reading
Matt Richtel and Andrew Pollack explore the complex policy issues involved with the pricing of products based on taxpayer-funded inventions and research in a front page New York Times story published today.
Kite Pharma is a California-based biopharmaceutical company working on various types of cell therapies for the treatment of cancer, in a bid to become the first pharmaceutical firm to gain successful FDA approval for this new class of cancer treatment.
Kite closely collaborates with the National Cancer Institute, which conducted significant early research into the forms of cell therapies that Kite is seeking to commercialize. NCI conducts clinical trials under Cooperative Research and Development Agreements (CRADAs) with Kite, and additionally has granted exclusive licenses on over a dozen patents to Kite on the same technologies.
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Kite Pharma, Inc., which is racing Juno Therapeutics and Swiss pharmaceutical giant Novartis to successfully bring the first T-cell receptor (TCR) therapy to market, relies heavily on government support in the course of its research and development.
As noted previously by KEI, in various comments to the National Institutes of Health, the NIH rarely discloses detailed information on its connections with industry, raising concerns about how the NIH licenses out taxpayer-funded technologies without regard for future prices or access for U.S. residents.
For a selected bibliography of news stories on Kite’s relationship with the National Cancer Institute, see here: /node/2644.
T-cell receptor therapy is the latest breakthrough in cancer treatment, and involves modifying a patient’s own cells to better track and destroy cancer proteins, and then reintroducing them into the body. (The NIH has a concise description for non-scientists here.)
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| Dr. Steven A. Rosenberg is the Principal Investigator for the National Cancer Institute on Kite’s 2012 CRADA. Dr. Rosenberg mentored Kite CEO and co-Founder Dr. Arie Belldegrun, and is also listed as a “Special Advisor” to Kite on their website. | Partnership for Public Service / Aaron Clamage |
According to Kite’s filings with the Securities and Exchange Commission (SEC), Kite has secured three Cooperative Research and Development Agreements (CRADAs) with the National Cancer Institute (NCI). In exchange for quarterly cash payments, the NCI conducts clinical trials and laboratory work on many of its own patented technologies, with the understanding that Kite will have the rights to commercialize any successful products developed through the CRADA.
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17 OCTOBER 2016
CONTACT: Zack Struver, zack.struver@keionline.org, +1-202-332-2670, or Paul Davis, pdavis@keionline.org, +1-202-332-2670
Note: Letter from Biolyse to HHS here: /wp-content/uploads/28-sept-2016-biolyse-to-hhs-letter.pdf
Letter from NGOs to HHS here: /wp-content/uploads/17-oct-2016-civil-society-letter-xtandi.pdf
Washington, DC — Today, over 50 patient, senior citizen, global health, development, social justice, and faith groups urged the United States Government to use its rights in a federally funded patented invention, and accept the request by a Canadian generic drug manufacturer (Biolyse Pharma) to enter into an agreement to manufacture and export an affordable version of the taxpayer-funded prostate cancer drug enzalutamide to South Africa and other countries with low per-capita incomes relative to the United States.
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Knowledge Ecology International recently obtained extensive email correspondence between officials at the National Institutes of Health (NIH), the Foundation for the National Institutes of Health (FNIH), and the National Football League (NFL), which shed light on accusations of NFL attempts to control the NIH research agenda related to repeat concussion injuries in football players.
The records, which we received through FOIA, are available here:
The National Institutes of Health, from 2011 through May of 2015, appears to have granted all requests for waivers of a requirement under federal law that patent holders who benefit from U.S. taxpayer-funding ensure that their patented inventions are manufactured in the United States.
The Bayh-Dole Act imposes various requirements on the grant of exclusive licenses by the patent holders of federally-funded inventions. In particular, the act generally requires that exclusive licensees “substantially” manufacture the invention in the United States.
The Act, however, also allows for the patent holder to obtain a waiver on the U.S. manufacturing requirement from the Federal agency that provided for the funding of the invention. According to a FOIA response recently obtained by Knowledge Ecology International, the NIH seems to grant every manufacturing waiver request that comes its way. Continue Reading