February, 02 2017, 12:45pm EDT
Statement on Proposed Trump Executive Order
In response to President Trump's comments on the Johnson Amendment and his proposed executive order allowing unlimited dark money for organizations opposed to same-sex marriage and abortion, Citizens for Responsibility and Ethics in Washington (CREW) Executive Director Noah Bookbinder released the following statement:
WASHINGTON
In response to President Trump's comments on the Johnson Amendment and his proposed executive order allowing unlimited dark money for organizations opposed to same-sex marriage and abortion, Citizens for Responsibility and Ethics in Washington (CREW) Executive Director Noah Bookbinder released the following statement:
"The president's statement this morning, together with this proposed executive order, constitutes a stunning assault on free speech, and a gift to dark money groups--as long as they agree with the president. The order would eliminate longstanding restrictions on political speech by nonprofit organizations, and favor religion, allowing the government to penalize some political viewpoints by nonprofit organizations while protecting the opposite viewpoints, and would sanction discrimination against a particular group of people. It reads like the administration was challenged to see how many violations of the Bill of Rights can be contained in one policy change.
Maybe most disturbing is that this policy would create a massive loophole for dark money, allowing unlimited sums of money to flow to nonprofit organizations for expressions of political views--but only on one side of the issues--with no disclosure of the source of that money. The administration should immediately reverse course on this proposed executive order which could do nothing but catastrophic harm to our democracy. President Trump promised to 'drain the swamp,' but he's filling it to the point where Washington is now waist deep in it."
Citizens for Responsibility and Ethics in Washington (CREW) is a nonprofit 501(c)(3) organization dedicated to promoting ethics and accountability in government and public life by targeting government officials -- regardless of party affiliation -- who sacrifice the common good to special interests. CREW advances its mission using a combination of research, litigation and media outreach.
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"As CMS negotiates the prices Medicare will pay for top-selling drugs, it should take into account the billions we've already lost due to these patenting tactics," said one researcher.
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When the Inflation Reduction Act became law in 2022, it included a historic provision that gave the Centers for Medicare and Medicaid Services (CMS) the ability to negotiate maximum fair prices for select drugs. This means that CMS now has an important tool to resist high prices imposed by pharmaceutical companies and lower the cost that Medicare recipients pay for their drugs. So far, Medicare has negotiated the maximum fair prices for 10 drugs, which will go into effect January 1, 2026.
But according to a report released Wednesday by the watchdog group Public Citizen, the manufacturers behind these drugs are able to rely on another method to protect their profits: patent abuses and evergreening tactics.
The report defines "evergreening tactics" as the practice of "patenting trivial and/or obvious modifications of existing medications to lengthen exclusivity on branded medicines."
The makers of the drugs Eliquis, Imbruvica, Jardiance, Farxiga, and Entresto, for example, obtained patents on what constitute trivial or minor changes to earlier patent claims, "such as crystalline forms of drug compounds which would be discovered and managed during routine testing that is part of the drug approval process," according to Public Citizen. These new patents allow the manufacturers to extend their monopoly on these drugs.
"Big Pharma patent abuse is cheating Medicare enrollees of more affordable drugs and costing taxpayers billions," said Public Citizen Access to Medicines program researcher Jishian Ravinthiran in a statement.
"Patent abuses enable Big Pharma companies to unfairly extend their monopolies and keep prices artificially high. As CMS negotiates the prices Medicare will pay for top-selling drugs, it should take into account the billions we've already lost due to these patenting tactics," he added.
The report makes this same point, arguing that the agency's initial offers on pharmaceuticals should take into account how long-monopoly drugs have been able to obtain longtime exclusivities on medicines by manipulating patents.
This is paramount, Public Citizen argues, given the scope of lost savings. The group estimates that Medicare will lose somewhere between $4.9 and $5.4 billion in savings that should have accrued to taxpayers if four out of the 10 drugs did not take advantage of patenting tactics, and therefore would have faced greater competition prior to negotiation.
"These lost savings are nearly as much as what Medicare is expected to save if negotiated prices go into effect on all of the selected drugs in the first year of the program ($6 billion)," according to the report.
As an example, the drug etanercept, which is marketed as Enbrel, is on the list of 10 drugs that will be subject to a negotiated cap come January 2026. Etanercept's maker Amgen did not contribute to the original research and development of etanercept, per Public Citizen, it just acquired the original maker of the drug, Immunex, in 2002.
Immunex's patent of etanercept was set to expire in 2019, but "by using abusive patent practices" Amgen was able to extend the patent protections through 2029, according to Public Citizen. Amgen was able to evade competition of two potential "biosimilar" competitors, Erelzi and Eticovo, which received FDA approval in the 2010s.
Referencing analysis done in a separate report, Public Citizen estimated "that biosimilars could have entered the market after August 2019 were it not for Amgen's unwarranted patent exclusivities, and we calculated Medicare would have spent $1,891,500,836 less on a net basis had enrollees been able to use lower-cost alternatives by the time negotiated prices go into effect on January 1, 2026."
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"I am infinitely saddened and angered" by such statements, said Tanaka.
He described his experience as a 13-year-old when the U.S. bombed Nagasaki, just a couple of miles away from his family's house, which was crushed by the impact.
He said he later found the charred body of one of his aunts and saw his grandfather close to death from the burns that covered his body.
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Thomas-Greenfield's speech sparked derision given the Biden administration's continued military support for an Israeli government that has been accused of wielding starvation as a weapon of war in Gaza, where—according to the latest U.N. Food and Agriculture Organization assessment—food aid has reached an all-time low under Israel's suffocating blockade.
"Hunger is a man-made tragedy that you helped make in Gaza."
Oxfam and other human rights groups have said that by arming the Israeli military as it obstructs humanitarian aid, the Biden administration is complicit in the starvation of Palestinians in Gaza and Israel's repeated attacks on aid workers attempting to feed the enclave's hungry.
"She is on a shamelessness tour in her final weeks as U.S. ambassador to the U.N.," journalist Jeremy Scahill wrote Wednesday in response to Thomas-Greenfield's speech. "She presided over numerous cease-fire vetoes as part of an administration that facilitated Israel's starvation policy against the Palestinians of Gaza. Listen to her remarks on 'hunger' in that context."
Yesterday, @USUN brought together humanitarian leaders to discuss solutions to the global food insecurity crisis.
Hunger is a man-made tragedy. But if it caused by man, that means it can be stopped by us, too.
Every human being, everywhere, has the right to food. pic.twitter.com/zczlerRHEc
— Ambassador Linda Thomas-Greenfield (@USAmbUN) December 10, 2024
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