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xavier becerra
Federal Judge Tosses Big Pharma Lawsuit Against Medicare Drug Price Negotiations
"Big PhRMA is so desperate to stop the Biden administration from lowering drug costs for seniors that they’re clogging the judicial system with spam lawsuits even in courtrooms they have no jurisdiction in."
Feb 13, 2024
A federal judge on Monday dismissed a lawsuit that the pharmaceutical industry's powerful trade group and allied organizations filed in an attempt to kill Medicare's new drug price negotiation program, which threatens manufacturers' virtually unrestrained power to drive up the prices of lifesaving medicines.
Judge David Alan Ezra of the U.S. District Court for the Western District of Texas tossed the lawsuit on procedural grounds, ruling that the National Infusion Center Association (NICA)—which does not manufacture or sell prescription drugs—lacked standing to sue.
Because NICA was the only plaintiff based in Texas, Ezra—a Reagan appointee—dismissed the lawsuit, which was joined by Pharmaceutical Research and Manufacturers of America (PhRMA) and the Global Colon Cancer Association. The coalition argued that the Medicare price negotiation program is unconstitutional, a claim that advocates have dismissed as cover for the industry's attempt to protect its profits.
A spokesperson for PhRMA, which spends tens of millions of dollars a year lobbying Congress, told Axios in a statement that the group is "disappointed" with the judge's decision and is weighing its next legal steps.
Tony Carrk, executive director of Accountable.US, said in response to Ezra's decision that "Big PhRMA is so desperate to stop the Biden administration from lowering drug costs for seniors that they're clogging the judicial system with spam lawsuits even in courtrooms they have no jurisdiction in."
"The big drug industry will say or do anything to strip away Medicare's new negotiation powers so that they can go back to business-as-usual price-gouging seniors on life-saving medicines," Carrk added.
The Lower Drug Prices Now campaign called on the "rest of the Big Pharma corporations suing Medicare" to stop fighting the program and "start negotiating."
The judge's ruling marks the second setback the pharmaceutical industry and its allies have faced in court since unleashing a barrage of lawsuits last year against the Medicare drug price negotiation program, which was launched under the Inflation Reduction Act. In late September, a federal judge allowed Medicare to continue implementing the program amid a legal challenge brought by the U.S. Chamber of Commerce and its affiliates.
Earlier this month, the Biden administration made its opening price offers to the manufacturers of 10 high-priced prescription drugs, including Pfizer, Merck, and Johnson & Johnson—each of which is suing over the Medicare program.
The companies now have less than a month to either accept the administration's offer or put forth a counter.
Xavier Becerra, secretary of the Health and Human Services Department, said Monday that the Texas judge's ruling "offers more reason for optimism that our work driving down the cost of prescription drugs will build."
"We will continue to implement the president's historic prescription drug price law, which is already delivering for the American people," said Becerra.
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Wyden Says GOP Medicaid Purge Puts 'Politics Before Children's Health'
New government data indicates that just nine Republican-led states are responsible for 60% of Medicaid and Children's Health Insurance Program disenrollments since April.
Dec 19, 2023
U.S. Sen. Ron Wyden ripped GOP governors on Monday for endangering the well-being of kids in their states for political purposes as they gut their Medicaid and Children's Health Insurance Program rolls at an alarming clip, sparking pushback from the Biden administration and healthcare advocates.
"Unfortunately, it's clear that too many Republican governors have chosen to put politics before children's health," Wyden (D-Ore.), chairman of the Senate Finance Committee, said in a statement after the U.S. Department of Health and Human Services (HHS) released new data showing that a small handful of GOP-led states account for the majority of Medicaid and CHIP disenrollments since April.
That month, the federal government began allowing states to resume eligibility checks and disenrollments that were paused during the Covid-19 pandemic. The health policy nonprofit KFF has estimated based on available data that 71% of those kicked off Medicaid across the U.S. since April have lost coverage for procedural reasons, such as a paperwork error.
Wyden said it's "encouraging" that HHS is giving governors "the opportunity to do right by the families they cover" and pledged to work with President Joe Biden's administration to "ensure everything possible is done to protect coverage for families walking an economic tightrope."
According to the HHS analysis, nine Republican-led states are responsible for roughly 60% of Medicaid and CHIP disenrollments this year: Arkansas, Florida, Georgia, Idaho, Montana, New Hampshire, Ohio, South Dakota, and Texas. Additionally, HHS said the 10 states that have not expanded Medicaid under the Affordable Care Act "have disenrolled more children than those that have expanded combined."
"States must take bold action to prevent a large increase in their uninsured child population. Three million losing Medicaid and counting is a terrible way to ring in the new year."
In letters to the nine states' GOP governors, HHS Secretary Xavier Becerra urged them to "ensure that no child in your state who still meets eligibility criteria for Medicaid or CHIP loses their health coverage due to 'red tape' or other avoidable reasons as all states 'unwind' from the Medicaid continuous enrollment provision that was in place during much of the Covid-19 public health emergency."
"HHS takes its oversight and monitoring role during the renewals process extremely seriously," Becerra added, "and will not hesitate to take action to ensure states' compliance with federal Medicaid requirements."
Becerra suggested a few strategies aimed at improving the states' often byzantine renewal processes, including boosting auto-renewals and engaging in more active outreach efforts to make sure families know how to keep their coverage.
At least one state leader, Republican Gov. Sarah Huckabee Sanders of Arkansas, signaled she has no intention of acting on Becerra's recommendations.
"The failing Biden admin sent letters to GOP-led states in a politically motivated PR stunt, accusing us of restricting Medicaid access. That's false," Sanders, who served as former President Donald Trump's press secretary, wrote on social media in response to Becerra's letter. "Arkansas is in compliance with state and federal law, while Biden plays politics at Christmas."
Arkansas has worked aggressively to curb its Medicaid rolls this year, stripping more than 427,000 people of coverage in just six months. In September alone, more than 21,000 people were removed from the program for not returning their enrollment paperwork, according to state data.
The nationwide Medicaid purge that began in April has been described as "the largest concentration of health insurance loss in American history," and both Republican governors and the Biden administration have faced criticism for failing to prevent disaster.
Georgetown University's Center for Children and Families (CCF) estimates that, as of Monday, more than 3 million children have been disenrolled from Medicaid since eligibility checks resumed in the spring.
"In 2022, 3.9 million children were uninsured, so even if the majority of children losing Medicaid have other sources of coverage, the number of uninsured children is rising sharply," CCF executive director Joan Alker wrote in a blog post on Monday. "States must take bold action to prevent a large increase in their uninsured child population. Three million losing Medicaid and counting is a terrible way to ring in the new year."
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'Rescheduling Is Not Enough,' Advocates Say of HHS Cannabis Recommendation
"The goal of any federal cannabis policy reform ought to be to address the existing, untenable chasm between federal marijuana policy and the cannabis laws of the majority of U.S. states," said NORML's deputy director.
Aug 30, 2023
Cannabis reform advocates and industry representatives on Wednesday renewed demands for legalizing marijuana at the federal level as U.S. Health and Human Services Secretary Xavier Becerra confirmed his department's rescheduling recommendation.
Marijuana is currently a Schedule I drug—the most restricted category under the Controlled Substance Act (CSA)—but President Joe Biden ordered Becerra and Attorney General Merrick Garland to initiate a review last October, when he issued a mass pardon for simple federal cannabis possession.
Bloomberg initially reported Wednesday that a Department of Health and Human Services (HHS) official on Tuesday wrote to Drug Enforcement Administration (DEA) chief Anne Milgram to recommend reclassifying cannabis Schedule III, a development Becerra confirmed on social media at 4:20 pm ET.
"Following the data and science, HHS has expeditiously responded to President Biden's directive to HHS Secretary Becerra and provided its scheduling recommendation for marijuana to the DEA on August 29, 2023," an HHS spokesperson toldMarijuana Moment. "This administrative process was completed in less than 11 months, reflecting this department's collaboration and leadership to ensure that a comprehensive scientific evaluation be completed and shared expeditiously."
A DEA spokesperson confirmed to the outlet that it received the HHS letter and said: "DEA has the final authority to schedule or reschedule a drug under the Controlled Substances Act. DEA will now initiate its review."
Asked about Bloomberg's reporting on Wednesday, White House Press Secretary Karine Jean-Pierre stressed to reporters that Biden requested the scheduling review, "it's going to be an independent process," and "it's going to be guided by evidence." She declined to comment regarding Biden's position on decriminalization.
NORML declared in an email that "rescheduling is not enough," and in response to the letter, deputy director Paul Armentano said that "it will be very interesting to see how DEA responds to this recommendation, given the agency's historic opposition to any potential change in cannabis' categorization under federal law. Further, for decades, the agency has utilized its own five-factor criteria for assessing cannabis' placement in the CSA—criteria that as recently as 2016, the agency claimed that cannabis failed to meet. Since the agency has final say over any rescheduling decision, it is safe to say that this process still remains far from over."
Armentano argued that "the goal of any federal cannabis policy reform ought to be to address the existing, untenable chasm between federal marijuana policy and the cannabis laws of the majority of U.S. states," and rescheduling "fails to adequately address this conflict."
"Just as it is intellectually dishonest to categorize cannabis in the same placement as heroin, it is equally disingenuous to treat cannabis in the same manner as anabolic steroids," he added. "The majority of Americans believe that cannabis ought to be legal and that its hazards to health are less significant than those associated with federally descheduled substances like alcohol and tobacco. Like those latter substances, we have long argued the cannabis plant should be removed from the Controlled Substances Act altogether, thereby proving state governments—rather than the federal government—the ability to regulate marijuana in the manner they see fit without violating federal law."
Medicinal use of cannabis is allowed by 38 states, three U.S. territories, and the District of Columbia while recreational adult use is permitted in 23 states, two territories, and D.C., according to the National Conference of State Legislatures.
Under the HHS plan, "state medical and adult-use marijuana programs will still remain federally illegal, meaning patients, consumers, and workers would remain subject to federal arrest; noncitizens would remain subject to deportation simply for possessing marijuana or working in the industry; and federal marijuana arrests and prosecutions will continue, previous arrests will not be expunged, and thousands will remain incarcerated in federal prison for marijuana violations," emphasized Cat Packer, director of drug markets and legal regulation at the Drug Policy Alliance.
"It also means that federal benefits, such as housing and nutritional assistance, will still be denied to certain people with previous marijuana convictions and the federal government will continue to be unable to foster a fair business environment that allows small and minority-owned marijuana businesses to compete with large corporate marijuana operators," noted Packer, urging the president to "limit the harms of marijuana criminalization" and work with Congress to pass the Cannabis Administration and Opportunity Act (CAOA).
U.S. Senate Majority Leader Chuck Schumer (D-N.Y.)—an advocate of federally legalizing cannabis and an original CAOA co-sponsor—said in a statement that "HHS has done the right thing and DEA should now quickly follow through on this important step to greatly reduce the harm caused by draconian marijuana laws."
"While this is a step forward, there is still much more that needs to be done legislatively to end the federal prohibition on cannabis and roll back the War on Drugs," Schumer added. "I am committed to continuing to work in Congress to pass important marijuana legislation and criminal justice reform."
U.S. Cannabis Council "enthusiastically" welcomed the HHS recommendation, saying on social media: "We believe that rescheduling to Schedule III will mark the most significant federal cannabis reform in modern history. President Biden is effectively declaring an end to [former President Richard] Nixon's failed war on cannabis and placing the nation on a trajectory to end prohibition."
While recognizing the range of benefits from the potential rescheduling—from making research easier to tax deductions for businesses—the industry group also emphasized its commitment to full cannabis legalization at the federal level.
National Cannabis Industry Association CEO Aaron Smith said that "moving cannabis to schedule III could have some limited benefit but does nothing to align federal law with the 38 U.S. states which have already effectively regulated cannabis for medical or adult use. The only way to fully resolve the myriad of issues stemming from the federal conflict with state law is to remove cannabis from the Controlled Substances Act and regulate the product in a manner similar to alcohol."
This post has been updated with comment from the Drug Policy Alliance.
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