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pharmaceutical industry
After Investigation by Sanders-Led Panel, Pharma Giant Caps Inhaler Costs
"We launched an investigation into big drug companies because the prices they were charging for inhalers just didn't add up," said Sen. Tammy Baldwin. "And looks like we were right."
Mar 07, 2024
Starting in June, the German pharmaceutical giant Boehringer Ingelheim will cap co-pays for its inhalers at $35 for U.S. patients—a decision that came just two months after members of a Senate panel led by Sen. Bernie Sanders launched an investigation into inhaler price gouging.
Combivent Respimat, one of Boehringer Ingelheim's inhaler products, carries a list price of around $500 in the U.S. That's roughly 70 times what the company charges for the same product in France, where patients can get the inhaler for $7.
Boehringer Ingelheim said Thursday that it plans to reduce the list prices of some of its inhalers.
Sanders (I-Vt.), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, called the company's moves "very positive steps in the right direction" and demanded that other major inhaler manufacturers "take similar action."
"A Vermont resident recently told my office that she has to pay $320 per month for Boehringer Ingelheim's Spiriva HandiHaler. As a result of today's decision, she could save more than $3,000 a year on the inhaler that she needs to breathe," Sanders said in a statement Thursday. "If Boehringer Ingelheim can take action to cap the cost of inhalers at $35 in the United States and lower the list price of some of the inhalers it manufactures, these other companies can do the same."
In January, Sanders and other Senate HELP Committee members announced a probe into "the extremely high prices" that Boehringer Ingelheim, AstraZeneca, and other companies charge for their inhalers.
"We launched an investigation into big drug companies because the prices they were charging for inhalers just didn't add up," Sen. Tammy Baldwin (D-Wis.), a member of the HELP panel, wrote on social media Thursday. "And looks like we were right."
We launched an investigation into big drug companies because the prices they were charging for inhalers just didn’t add up.
And looks like we were right.
I’m glad to see some of the price gouging end and proud to help lower costs for Wisconsin families. pic.twitter.com/QluMNCSwJA
— Sen. Tammy Baldwin (@SenatorBaldwin) March 7, 2024
Boehringer Ingelheim was also facing scrutiny from the Federal Trade Commission (FTC). In November, the agency said it believes some of the company's patents "may have been improperly listed in the Orange Book," which includes products the agency deems safe and effective.
"Patents improperly listed in the Orange Book may delay lower-cost generic drug competition," the FTC wrote in a letter to Boehringer Ingelheim. "By listing their patents in the Orange Book, brand drug companies may benefit from an automatic, 30-month stay of FDA approval of competing generic drug applications."
On Wednesday, as Reutersreported, a class-action lawsuit filed in federal court by the Massachusetts Laborers' Health and Welfare Fund accused Boehringer Ingelheim of "improperly submitting patents to the U.S. Food and Drug Administration to delay generic competition and inflate prices for its lung disease drugs Combivent Respimat and Spiriva Respimat."
"As a result of Boehringer's wrongful Orange-Book-listing scheme, there [are], to this day, no affordable generic versions of either Combivent Respimat or Spiriva Respimat," the lawsuit states. "Payors must continue to pay for expensive brand-name products, instead of affordable generic products that should have been available years ago. This has caused payors, including the plaintiff, to suffer many millions, if not billions, of dollars in overcharges over the past three years."
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Federal Judge Dismisses Pharma Giant's Challenge to Medicare Drug Price Negotiations
"The court has rejected AstraZeneca's self-serving arguments and essentially said the company didn't have a leg to stand on," said one advocate.
Mar 01, 2024
The president of consumer advocacy group Public Citizen on Friday urged Big Pharma to "drop its far-fetched lawsuits and accept that the era of Medicare price negotiation is here to stay," after a federal judge in Delaware rejected drug company AstraZeneca's case challenging provisions under the Inflation Reduction Act.
AstraZeneca Pharmaceuticals LP et al. v. Becerra et al. is one of several cases that drug companies have filed against the federal government seeking to block Medicare from negotiating drug prices on behalf of patients—as the governments of every other high-income country do, with Americans paying as much as four times what people in countries such as the United Kingdom and Canada pay for their medications.
The company claimed that the Centers for Medicare & Medicaid Services violated the Administrative Procedure Act.
Chief Judge Colm Connolly in the U.S. District Court for the District of Delaware ruled that "because AstraZeneca's participation in Medicare is not involuntary, AstraZeneca does not have a protected property interest in selling drugs to the government at prices the government will not agree to pay. Accordingly, AstraZeneca's due process claim fails as a matter of law."
"Drug corporations have no constitutional right to price gouge Medicare, contrary to Big Pharma's claims."
In other words, said Patients for Affordable Drugs (P4AD), the judge emphasized that "the company's desire for higher prices does not supersede the government's ability to protect patient interests."
"On behalf of patients across this country, we are encouraged but not surprised that the court has rejected AstraZeneca's self-serving arguments and essentially said the company didn't have a leg to stand on," said Merith Basey, the group's executive director. "This ruling sends a clear message that Big Pharma's greed cannot continue to be prioritized over patients' well-being and underscores the importance of Medicare negotiation to begin to rein in exorbitant drug prices."
"The judge's decision reaffirms that pharmaceutical companies like AstraZeneca have the option to participate in Medicare voluntarily, accepting slightly lower negotiated prices if they wish to access a market worth billions," added Basey. "Once again, a judge has reviewed drug company claims, and the result has gone against the drug company and for the people of the United States."
AstraZeneca's drug Farxiga, which is used to treat Type 2 diabetes, was one of 10 medications selected by the Biden administration last year for the first round of negotiations under the Inflation Reduction Act's (IRA) Medicare Drug Price Negotiation Program. In 2022, the company reported nearly $4.4 billion in revenue from Farxiga.
P4AD said Connolly's ruling was a victory for patients like Karen, a Pueblo West, Colorado resident.
"I am on Medicare and was prescribed Farxiga with a bill of over $600 for a three-month supply. I am on a fixed income and can no way afford that amount of money," Karen told the group, which has signed onto amicus briefs in seven different cases regarding Medicare price negotiations.
Tony Carrk, executive director of Accountable.US, noted that Big Pharma previously spent millions lobbying against the drug price negotiation provisions in the IRA.
“Big drug company executives are stopping at nothing to price gouge Americans and pad their profits," said Carrk. "Now they are trying to do it by clogging the judicial system with meritless lawsuits. Today's ruling is a victory for the Biden administration's historic cost-lowering program and for seniors who need lower prescription drug costs."
Robert Weissman, president of Public Citizen, pointed out that the IRA's restraints on Big Pharma's price gouging are only "modest" but will make a difference to seniors, saving $100 billion over a decade.
"In response, Big Pharma has launched a flurry of preposterous lawsuits against the Medicare drug negotiation provisions in the Inflation Reduction Act," said Weissman. "As Public Citizen has argued in amicus briefs, drug corporations have no constitutional right to price gouge Medicare, contrary to Big Pharma's claims."
Weissman said his expects that with seven pending cases, "today's decision is the first of many rejecting Big Pharma's attack on the act's effort to rein in exorbitant prescription drug prices."
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Families Rally for Opioid Accountability as Supreme Court Hears Purdue Case
"I don't want their money," one woman who lost a son to the opioid crisis said of the Sackler family. "I want them in prison."
Dec 04, 2023
At the U.S. Supreme Court on Monday, families whose loved ones are among the tens of thousands of Americans who have died of opioid use disorder each year over the past two decades rallied to push the nine justices to reject a proposed bankruptcy plan that would give the former owners of Purdue Pharma legal immunity—with many joining the U.S. Justice Department in arguing that the company should not be released from accountability for the opioid epidemic.
Purdue Pharma filed for bankruptcy in 2019, as the number of Americans killed by opioids hit 50,000 and the OxyContin manufacturer faced thousands of lawsuits alleging its aggressive marketing of the addictive painkiller had fueled the rising death toll.
The company agreed to settle the lawsuits for $10 billion, with the Sackler family—which oversaw Purdue when OxyContin was introduced and flooded communities across the U.S.—contributing $4 billion. In exchange, the Sacklers would be shielded from future lawsuits.
The bankruptcy plan—which now includes $6 billion from the Sacklers following a push from lawsuit plaintiffs—has been approved by state and local governments, tribes, and families and individuals who would be entitled to money.
But the U.S. Trustee Program, a watchdog at the Justice Department, has joined some families in arguing that the Sacklers should not be shielded from liability for the opioid crisis.
"No Sackler immunity at any $$," read one sign held by a woman outside the Supreme Court on Monday, while another said, "My dead son does not release Sacklers."
The issue at hand in the case, Harrington v. Purdue Pharma, is whether it is legal to give a third party—the Sackler family—legal immunity in a bankruptcy case even though they themselves have not declared bankruptcy, also known as nonconsensual third-party release.
A lawyer for groups and individuals told the court that families and governments are highly unlikely to get any more out of Purdue and the Sacklers than the money the company and family have offered as part of the deal.
The plan would include $161 million in a trust set aside for Native American tribes and $700 million to $750 million in a trust for families and individuals who were able to file claims, with payouts expected to range from about $3,500 to $48,000. Governments would use the money to set up addiction treatment centers and other programs to mitigate the opioid crisis.
"Forget a better deal—there is no other deal," lawyer Pratik Shah told the Supreme Court on Monday.
Curtis Gannon, representing the U.S. Trustee Program, noted that the Sackler family already showed that a "better deal" could be possible when it offered $6 billion for the plan instead of $4 billion. The Justice Department is advocating for a new settlement that would not include nonconsensual third-party releases, saying the current bankruptcy deal violates federal law.
"We do hope there is another deal at the end of this," said Gannon.
The justices appeared split on the case, in which a ruling is expected next summer. Justice Ketanji Brown Jackson noted that appeals courts do not allow bankruptcy plans that take away the rights of alleged victims to sue parties that have not declared bankruptcy.
Outside the court, Alexis Pleus, who lost her son to opioid use disorder, told Aneri Pattani of KFF Health News that many families, including hers, will not be entitled to money under the current deal because they are required to provide records such as the original opioid prescription.
Beth Macy, author of the book Dopesick, told CNN Monday morning that while some families "are divided" about whether the bankruptcy plan and payouts should move forward, as the U.S. Trustee Program "has pointed out, only 20% of the families who were eligible to vote on [the proposal], even voted."
"I don't want their money," Jen Trejo, whose son Christopher was prescribed OxyContin at age 15 and died of an overdose when he was 32, told Pattani. "I want them in prison."
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