February, 27 2019, 11:00pm EDT
Schumer-Carper Resolution Fails the Laugh Test
A resolution on climate change was introduced today in the Senate by Minority Leader Schumer (D-NY) and Ranking Member Carper (D-Del.). It simply asserts that climate change is real and that Congress should address it.
Nicole Ghio, Fossil Fuel Program Manager at Friends of the Earth, issued the following statement in response:
WASHINGTON
A resolution on climate change was introduced today in the Senate by Minority Leader Schumer (D-NY) and Ranking Member Carper (D-Del.). It simply asserts that climate change is real and that Congress should address it.
Nicole Ghio, Fossil Fuel Program Manager at Friends of the Earth, issued the following statement in response:
This resolution is wasting time while our climate burns. The window for moderate action on climate change has closed. A symbolic critique of Republicans for having no plan rings hollow if centrist Democrats lack the courage to press for real solutions. This resolution sets a low bar at a time when the fundamental transformation of our economy that delivers on the promise of a Green New Deal is the only real climate solution worth discussing.
Friends of the Earth fights for a more healthy and just world. Together we speak truth to power and expose those who endanger the health of people and the planet for corporate profit. We organize to build long-term political power and campaign to change the rules of our economic and political systems that create injustice and destroy nature.
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As Ramadan Begins, Ilhan Omar Introduces House Resolution to Condemn Islamophobia
"In order to confront the evils of religious bigotry and hatred, we must come to understand that all our destinies are linked," said Omar, a former refugee from Somalia and one of two Muslim women in Congress.
Mar 23, 2023
Joined by Democratic House colleagues and activists outside the U.S. Capitol on Thursday—the first full day of Ramadan—Minnesota Congresswoman Ilhan Omar announced a new resolution condemning Islamophobia and commemorating the recent anniversary of the 2019 Christchurch, New Zealand mosque massacre.
Omar's office said the resolution—which is co-sponsored by more than 20 House Democrats—"comes after continued violence and threats made against religious minorities, particularly Muslims," while adding that the March 15, 2019 murder of 51 Muslim worshippers at the Al Noor Mosque in Christchurch by an Australian white supremacist "was a stated source of inspiration for mass shootings in the United States."
These include the deadly synagogue shooting in Poway, California; the massacre of 23 people, most of them of Mexican origin, at a Walmart in El Paso, Texas; and the murder of 10 people by a white supremacist in a Buffalo, New York grocery store.
Omar said:
As we begin the holy month of Ramadan, we must reaffirm that all people of faith should have the right to worship without fear. According to the Council on American-Islamic Relations, anti-Muslim hate crimes and attacks are at an all-time high. The attack in Christchurch, motivated by an extremist ideology of white supremacy, anti-Muslim hate, and the so-called replacement theory resonates deeply for Muslims in nearly every corner of the globe.
We also know that this increase in hate is not isolated to only Muslims. Church bombings, synagogue attacks, and racial hate crimes are also on the rise.
"In order to confront the evils of religious bigotry and hatred, we must come to understand that all our destinies are linked," Omar added. "That's why I'm proud to lead my colleagues in condemning the rise in Islamophobia and affirming the rights of religious minorities in the United States and around the world."
Robert McCaw, director of government relations at the Council on American-Islamic Relations, also spoke at Thursday's event, saying that "it is with a heavy heart that CAIR welcomes Omar's resolution," which "recognizes the threat posed by rising global Islamophobia to American Muslims and Muslims in other countries across the world, as well as the threat white supremacism poses to all people."
"It is incredibly important for Congress to lead the way in rejecting these hateful and dangerous ideologies, and CAIR calls on both sides of the aisle to co-sponsor and adopt this resolution," McCaw added. "As we remember the lives lost in Christchurch, we must continue to work towards a world where everyone is treated with humanity and dignity, regardless of their faith, ethnicity, or background."
In 2021, the Democratic-controlled House narrowly passed a resolution introduced by Omar aimed at combating Islamophobia after Rep. Lauren Boebert (R-Col.) referred to her and Rep. Rashida Tlaib (D-Mich.)—the only two Muslim women in Congress—as the "jihad squad."
The House GOP, which now narrowly controls the chamber, voted last month to remove Omar from the foreign affairs panel. Just before the vote, the congresswoman said that Republicans "are not OK with having a Muslim have a voice on that committee."
Omar's new federal resolution stood in stark contrast with Texas state Rep. Tony Tinderholt's (R-94) vote against a legislative resolution celebrating Ramadan.
"As a combat veteran, I served beside many local translators who were Muslims and good people," the Iraq War veteran explained. "I can also attest that Ramadan was routinely the most violent period during every deployment."
"Texas and America were founded on Christian principles and my faith as a Christian prevents me from celebrating Ramadan," Tinderholt added.
Responding to Tinderholt's statement, CAIR tweeted: "Every elected official has the right to express their own sincerely held religious beliefs—and we welcome that. But to insult another religion is uncalled for and harmful."
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Cancer Patients Challenge Biden Admin's Refusal to Lower Price of Lifesaving Drug
"We request HHS to consider this appeal directly... because the NIH has repeatedly demonstrated its unwillingness to even acknowledge that the Bayh-Dole Act includes an obligation to make products invented with federal funds 'available to the public on reasonable terms.'"
Mar 23, 2023
Two days after President Joe Biden's administration rejected a petition asking federal regulators to use their authority to lower the astronomical price of a lifesaving prostate cancer drug developed entirely with public funds, petitioners on Thursday filed an administrative appeal.
At issue is enzalutamide, a drug the Japanese pharmaceutical giant Astellas and its U.S. counterpart Pfizer sell under the brand name Xtandi. Although Xtandi owes its existence to U.S. taxpayers, who bankrolled 100% of its development, an annual supply of the drug costs $189,900 in the United States—three to six times more than its list price in other wealthy nations.
In late 2021, prostate cancer patients Robert Sachs, Clare Love, and Eric Sawyer petitioned the U.S. Department of Health and Human Services (HHS) to exercise its "march-in rights" against Xtandi. Under the Bayh-Dole Act, the federal government can reclaim and redistribute patents for inventions created with public funding—enabling generic competitors to produce cheaper versions—when "action is necessary to alleviate health or safety needs" or when an invention's benefits are not being made "available to the public on reasonable terms."
HHS Secretary Xavier Becerra referred the petition to the National Institutes of Health (NIH), whose acting Director Lawrence Tabak argued in a Tuesday letter that "Xtandi is widely available to the public on the market," citing Astellas' estimate that "more than 200,000 patients were treated with Xtandi from 2012 to 2021."
Even with insurance, co-pays for Xtandi are sky-high. Medicare recipients, for example, are expected to pay roughly $10,000 per year for the medicine. Especially for the millions of uninsured and underinsured people in the U.S., Xtandi remains completely out of reach.
Tabak's letter went on to say that Xtandi's "practical application is evidenced by the 'manufacture, practice, and operation' of the invention and the invention's 'availability to and use by the public….'" As Knowledge Ecology International executive director James Love lamented, the NIH completely elided any mention of "reasonable terms," editing out that key phrase from Bayh-Dole.
In their appeal, the petitioners wrote: "The petition focused on a single issue: the reasonableness of charging U.S. cancer patients three to six times more than residents of other high-income countries for the drug Xtandi."
"There is no dispute about the following facts," the appeal continues. "Xtandi was invented on grants from the U.S. Army and the NIH at UCLA, a public university. The patents were licensed eventually to Astellas, a Japanese drug company, with a partnership share now held by Pfizer, following its 2016 $14 billion acquisition of Medivation, UCLA's original licensee, that occurred just after the NIH rejected an earlier march-in request on Xtandi. The prices in the United States have consistently been far higher than the prices in other high-income countries."
Prior to the 2021 petition, Clare Love and prostate cancer patient David Reed filed a petition, later joined by Sachs, with the U.S. Department of Defense (DOD) after the Senate Armed Services Committee instructed the Pentagon to initiate march-in proceedings when the price of a drug created with a DOD grant exceeds the median price in seven large high-income nations. The Pentagon, however, has yet to acknowledge or act on the petition submitted to it in February 2019.
"If you consider both of these requests together, a petition to exercise the government's march-in or other rights in the Xtandi patents has been pending before the federal government for more than four years," Thursday's appeal states. "The HHS petition was filed 16 months ago."
It continues:
The petitions were filed with the DOD and HHS instead of the NIH because the NIH has repeatedly demonstrated its unwillingness to even acknowledge that the Bayh-Dole Act includes an obligation to make products invented with federal funds 'available to the public on reasonable terms.' This is demonstrated by a track record of dismissing multiple requests to use the government's Bayh-Dole safeguard to address pricing abuses and access restrictions, including those concerning the federal government's march-in rights under 35 USC § 203, and the federal government's global royalty-free license, under 35 USC § 202(c)(4). There are also extensive email records between Mark Rohrbaugh, currently NIH special adviser for technology transfer who is a long-time agency official, and lobbyists for drug companies and university rights holders, obtained through Freedom of Information Act requests, which not only express opposition to any safeguards regarding unreasonable pricing but organize public relations efforts against using a march-in request to address the pricing of products.
"HHS chose to assign to the NIH the evaluation of our petition regarding Xtandi," says the appeal. "We request HHS to consider this appeal directly, and not assign NIH to review its own decision. The latter would be tantamount to no review at all."
Since Bayh-Dole was enacted in 1980, "march-in rights have never been used... and NIH has repeatedly rejected the idea that affordability is a reasonable term," The American Prospectreported Wednesday. With Xtandi, "advocates thought they found the perfect test case for a new administration that paid lip service to lowering prescription drug costs."
As The Levernoted on Wednesday, the NIH's decision this week was consistent with Biden's track record:
Biden was vice president when the Obama administration rejected congressional Democrats' demand that the government use the same power to lower the skyrocketing prices of medicine in America.
As a senator in 2000, Biden was one of just eight Democrats who helped pharmaceutical lobbyists kill a measure spearheaded by Sen. Paul Wellstone (D-Minn.) and then-Rep. Bernie Sanders (I-Vt.) that would have reinstated the Reagan-era requirement that drug companies sell medicines developed with public money at a reasonable price.
That requirement was repealed by the Clinton administration in 1995, following pressure by drugmakers.
But Becerra's acquiescence to Big Pharma was more surprising. Prior to joining the Biden administration, the HHS secretary had expressed support for wielding the executive branch's authority to rein in soaring drug prices.
As the attorney general of California in the summer of 2020, "Becerra demanded the Trump administration use existing law to lower the price of medicines that were originally developed at taxpayer expense," The Lever reported. "As a member of Congress in 2016, Becerra signed on to a letter to the Obama Department of Health and Human Services calling on officials to broadly use 'march-in rights' to lower the cost of prescription drugs—including 'specialty drugs, like those to treat cancer, which are frequently developed with taxpayer funds.'"
Despite pressure from numerous members of Congress and medicine affordability advocacy groups, the NIH declared Tuesday that it "does not believe that use of the march-in authority would be an effective means of lowering the price of the drug."
Instead, the agency vowed to "pursue a whole-of-government approach informed by public input to ensure the use of march-in authority is consistent with the policy and objective of the Bayh-Dole Act," a move that progressive advocates denounced as a "pathetic" attempt to deflect criticism of its failure to use or threaten to use its legal power.
“This is a drug that was invented with taxpayer dollars by scientists at UCLA and can be purchased in Canada for one-fifth the U.S. price," Sanders said Tuesday. "The Japanese drugmaker Astellas, which made $1 billion in profits in 2021, has raised the price of this drug by more than 75%."
"How many prostate cancer patients will die because they cannot afford this unacceptable price?" asked Sanders, chair of the Senate Committee on Health, Education, Labor, and Pensions.
During a Wednesday hearing, Sanders made the case for changing "the current culture of greed into a culture which understands that science and medical breakthroughs should work for ordinary people, and not just enrich large corporations and CEOs."
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Consumer Advocates Applaud as Federal Court 'Yet Again' Finds CFPB's Funding Constitutional
"If the Supreme Court follows suit," said one watchdog, "it will mark a major win for everyday consumers impacted by abusive fees, predatory lenders, and corporate greed."
Mar 23, 2023
U.S. Sen. Elizabeth Warren, who established the Consumer Financial Protection Bureau in 2010, was among the consumer advocates celebrating on Thursday as a federal court in New York City ruled that the bureau's funding structure is constitutional—rebuking years of right-wing and corporate attacks on the agency.
The Massachusetts Democrat expressed hope that the U.S. Supreme Court, which is expected to hear arguments in a separate but related case later this year, "follows more than a century of law and historical precedent" and also rules in favor of the CFPB, which has regulated debt collectors, payday lenders, credit card companies, and other financial businesses for more than a decade.
"Yet again, the constitutionality of the CFPB has been upheld, as it has been time and time before," said Warren.
The 2nd U.S. Circuit Court of Appeals ruled in favor of the bureau Thursday in a case stemming from a debt collector's attempt to avoid a subpoena from the CFPB in 2017.
A lower court ruled in the case in August 2020 that the bureau's funding structure is constitutional, but the 5th U.S. Circuit Court of Appeals in New Orleans said last year in the case set to be heard by the Supreme Court that the funding violates the Constitution's appropriations clause and the separation of executive and legislative powers.
The CFPB is funded by the Federal Reserve rather than through appropriations voted on annually by lawmakers.
Writing for the three-judge 2nd Circuit panel that voted unanimously in favor of the bureau, Judge Richard Sullivan noted that the justice system "has consistently interpreted the appropriations clause to mean simply that 'the payment of money from the Treasury must be authorized by a statute,'"—which doesn't apply to the CFPB since it receives no funding from the U.S. Treasury Department.
An upcoming ruling by the Supreme Court that supports the 2nd Circuit's finding would "mark a major win for everyday consumers impacted by abusive fees, predatory lenders, and corporate greed," said government watchdog Accountable.US.
"The CFPB is a vital voice for consumers and protects Americans from unfair and abusive practices," said Rep. Nydia Velázquez (D-N.Y.). "We can't allow these protections to be weakened."
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