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The Biden Administration Is Pulling Drug Prices Down Out of the Stratosphere
The president’s Inflation Reduction Act contained several provisions affecting drug prices, including three that began to take effect in 2023.
Apr 03, 2024
Prices for prescription drugs in America average almost three times as much as in other major nations around the world. Even more, the companies that set those prices are doing everything they can to make sure they stay in the stratosphere: They’ve filed suit to overturn an upcoming reform, having Medicare negotiate the prices of some of the costliest and most commonly used drugs.
The makers don’t think they need to explain themselves, either. If they hadn’t been threatened with subpoenas, their CEOs would never have showed up to waffle their way through a Senate hearing on drug pricing earlier this year.
Lastly, the companies argue that critics of high prices should instead be praising the industry for all the research it carries out to make the drugs available in the first place—failing to mention, of course, the critical role that government funding regularly plays in the development of new drugs.
If you wonder how patients could be harmed by lower drug prices, feel free to ask the Pharmaceutical Research and Manufacturers of America.
A big contributor to insane drug prices is the billions spent on those incessant drug commercials. Hour after hour, eyes glazing over, TV watchers are bombarded with happy-time ads for Rinvoq, Skyrizi, Dupixent, Sanofi, Jardiance, on and on and then some.
Thank heaven for mute buttons; more to the point, thank heaven that the Biden administration is leading the way to somewhat less insanity.
The president’s Inflation Reduction Act contained several provisions affecting drug prices, including three that began to take effect in 2023. The bill capped the price of insulin at $35 a month, made some vaccines free, and required drug companies that raised prices faster than the rate of inflation to pay rebates to Medicare.
Here’s President Joe Biden taking a victory lap during his State of the Union address: “That’s not just saving seniors money, it’s saving taxpayers money. We cut the federal deficit by $160 billion because Medicare will no longer have to pay those exorbitant prices…”
Other cost-saving provisions are coming as well. Starting in 2025, out-of-pocket prescription drug costs for retirees covered under Medicare Part D will be capped at $2,000. Annual limits after 2025 will be adjusted based on inflation rates.
Medicare-negotiated drug prices, mentioned earlier, have an effective date of 2026 (unless, of course, they get derailed by Big Pharma). Negotiations between Medicare and the makers are already underway for the first 10 covered drugs; all by themselves, those 10 accounted for over $3.4 billion in out-of-pocket costs in 2022.
Drug prices could fall even more sharply under the terms of the proposed 2025 budget for the Department of Health and Human Services. Instead of Medicare-negotiated prices for 10 drugs, the number would rise to 50 per year.
Presidents also have the power to make things happen without congressional legislation, and a Biden executive order could result in allowing states to import lower-cost drugs in bulk from Canada. The Food and Drug Administration approved Florida’s request early this year, and other states are hoping to follow. (Full disclosure: Florida’s Republican Gov. Ron DeSantis and former President Donald Trump also pushed for FDA’s approval.)
Drug companies reflexively oppose lower drug prices, so of course they reflexively oppose imports from Canada. A statement from their trade association said they were “considering all options for preventing this policy from harming patients.”
If you wonder how patients could be harmed by lower drug prices, feel free to ask the Pharmaceutical Research and Manufacturers of America. Another question too: Ask if they could please, please, please cut down on those commercials (or better yet, just end them).
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Abortion Defenders Decry 'Baseless' Attack on Mifepristone as SCOTUS Hears Case
"The overturn of Roe was just the first step in the far right's relentless campaign to restrict women's reproductive freedom," said one advocate. "We always knew they would come for medication abortion, too."
Mar 26, 2024
As the U.S. Supreme Court heard oral arguments Tuesday in a case brought by right-wing activists seeking to sharply limit access to a commonly used abortion pill, reproductive rights advocates renewed warnings that Republicans' endgame isn't just making abortion a states' rights issue, but rather forcing a nationwide ban on all forms of the medical procedure.
Thehigh court justices—including six conservatives, half of them appointed by former President Donald Trump, the presumptive 2024 GOP presidential nominee—are hearing oral arguments in Food and Drug Administration v. Alliance for Hippocratic Medicine, a case brought by the right-wing Alliance Defending Freedom on behalf of anti-abortion doctors. The case involves the abortion pill known by the generic name mifepristone, which was first approved by the FDA in 2000 as part of a two-drug protocol to terminate early-stage pregnancies.
"If the Supreme Court refuses to follow the evidence and imposes medically unnecessary restrictions on mifepristone, it will be just another stepping stone in the anti-abortion movement's end goal of a nationwide ban on abortion."
"Mifepristone has been used by millions of women over the last 20 years, and its safety and effectiveness have been well-documented," said Jamila Taylor, president and CEO of the Institute for Women's Policy Research. "The drug has taken on even greater importance for women's health since the Supreme Court overturned Roe v. Wade, and the far right has moved to block women's access to healthcare at every turn."
In a dubious practice known as "judge shopping," the plaintiffs filed their complaint in Amarillo, Texas, where Matthew Kacsmaryk, the sole federal district judge and a Trump appointee, ruled last April that the FDA's approval of mifepristone was illegal. Shortly after Kacsmaryk's ruling, a federal judge in Washington state issued a contradictory decision that blocked the FDA from removing mifepristone from the market. The U.S. Department of Justice subsequently appealed Kacsmaryk's ruling.
Later in April 2023, the Supreme Court issued a temporary order that allowed mifepristone to remain widely available while legal challenges continued. A three-judge panel of the right-wing 5th U.S. Circuit Court of Appeals ruled last August that the FDA's 2016 move to allow mifepristone to be taken later in pregnancy, mailed directly to patients, and prescribed by healthcare professionals other than doctors, was likely illegal. However, the court also allowed the pill to remain on the market pending the outcome of litigation.
In an analysis of the case published Tuesday, jurist Amy Howe explained:
There are three separate questions before the justices on Tuesday. The first one is whether the challengers have a legal right to sue, known as standing, at all. The FDA maintains that they do not, because the individual doctors do not prescribe mifepristone and are not obligated to do anything as a result of the FDA's decision to allow other doctors to prescribe the drug.
The court of appeals held that the medical groups have standing because of the prospect that one of the groups' members might have to treat women who had been prescribed mifepristone and then suffered complications—which, the FDA stresses, are "exceedingly rare"—requiring emergency care. But the correct test, the FDA and [mifepristone maker] Danco maintain, is not whether the groups' members will suffer a possible injury, but an imminent injury.
Destiny Lopez, acting co-CEO of the Guttmacher Institute, called the plaintiffs' claims "baseless."
"If the Supreme Court refuses to follow the evidence and imposes medically unnecessary restrictions on mifepristone, it will be just another stepping stone in the anti-abortion movement's end goal of a nationwide ban on abortion," she said on Tuesday. "As the court weighs its decision, let's be clear that the only outcome that respects facts and science is maintaining full access to mifepristone."
As more than 20 states have banned or restricted abortion since the Supreme Court's June 2022 Dobbs v. Jackson Women's Health Organization ruling overturnedRoe v. Wade and voided half a century of federal abortion rights, people have increasingly turned to medication abortion to terminate unwanted pregnancies. And while Republicans have often claimed that overturning Roe was not meant to ban all abortions but merely to leave the issue up to the states, GOP-authored forced pregnancy bills and statements by Republican lawmakers and candidates including Trump—who last week endorsed a 15-week national ban—belie conservatives' goal of nationwide prohibition.
Project 2025, a coalition of more than 100 right-wing groups including Susan B. Anthony Pro-Life America and other anti-abortion organizations, wants to require the FDA to ban drugs used for medication abortions, protect employers who refuse to include contraceptive coverage in insurance plans, and increase surveillance of abortion and maternal mortality reporting. The coalition is reportedly drafting executive orders through which Trump, if reelected, could roll back Biden administration policies aimed at protecting and expanding abortion access.
"The overturn of Roe was just the first step in the far right's relentless campaign to restrict women's reproductive freedom. We always knew they would come for medication abortion, too," Taylor said. "But conservatives seeking to block access to mifepristone are not concerned about women's safety; they want to block all abortion options for women and prevent them from making their own reproductive decisions, even in their own homes."
Right-wing groups including the Heritage Foundation have been pressing Trump to invoke the Comstock laws, a series of anti-obscenity statutes passed in 1873 during the Ulysses S. Grant administration. One of the laws outlawed using the U.S. Postal Service to send contraceptives and punished offenders with up to five years' hard labor. Named after Victorian-era anti-vice crusader and U.S. postal inspector Anthony Comstock, the laws were condemned by progressives of the day, with one syndicated newspaper editorial accusing Comstock of striking "a dastard's blow at liberty and law in the United States."
Slate senior writer Mark Joseph Stern said Tuesday that far-right Justices Clarence Thomas and Samuel Alito—who wrote the majority opinion in Dobbs—"are clearly eager to revive the Comstock Act as a nationwide ban on medication abortion, and maybe procedural abortion, too."
"That would subject abortion providers in all 50 states to prosecution and imprisonment," he added. "No congressional action needed."
Progressive U.S. lawmakers joined reproductive rights advocates in rallying outside the Supreme Court on Tuesday.
"Mifepristone is safe and effective and has been used in our country for decades," said Rep. Rashida Tlaib (D-Mich.). "These far-right justices need to stop legislating from the bench."
Rep. Ayanna Pressley (D-Mass.) asserted that "medication abortion is safe, effective, and routine healthcare."
"Over half of U.S. abortions are done this way and we have decades of scientific evidence to back up its safety," she added. "SCOTUS must protect access to mifepristone and we must affirm abortion care as the human right that it is."
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Big Pharma Vows to Fight Historic FDA Approval of Medicine Imports From Canada
The FDA's decision is "a win for consumers and for Bernie Sanders, who first spearheaded bus trips to Canada 25 years ago," wrote David Sirota, a former Sanders campaign adviser.
Jan 06, 2024
The pharmaceutical lobby pledged Friday to do everything in its power to fight back after the Food and Drug Administration approved a Florida program that will allow the state to import medications from Canada at a steep discount relative to sky-high U.S. prices, which force millions of Americans to skip doses to save money.
"PhRMA is considering all options for preventing this policy from harming patients," Stephen Ubl, the industry trade group's CEO, said in a statement, condemning the FDA's decision as "reckless."
Prescription drug importation from Canada is a broadly popular approach that has long been advocated by Sen. Bernie Sanders (I-Vt.), who more than two decades ago led a caravan of women across the U.S.-Canada border to purchase breast cancer medication. Sanders, then a member of the House, spearheaded a legislative effort to approve more drug imports, but Republicans packed the final bill with loopholes for Big Pharma.
Sanders traveled across the Canadian border again in 2019 with Type 1 diabetes patients looking to buy insulin, which is dangerously pricey in the U.S.
Now, following the FDA's decision on Friday, Republican-led Florida is on track to become the first U.S. state to import cheaper prescription drugs from the country's northern neighbor. The RAND Corporation has estimated that Canadians pay less than half of what Americans pay for brand-name drugs.
The New York Times, which was first to report the FDA's approval, noted that Florida has estimated it "could save up to $150 million in its first year of the program, importing medicines that treat HIV, AIDS, diabetes, hepatitis C, and psychiatric conditions."
"With its approval in hand, Florida has more work to do," the Times added. "Before it can distribute Canadian drugs, the state must send the FDA details on those it plans to import. The state has to ensure that the drugs are potent and not counterfeit. It also must put FDA-approved labels on medications instead of those used in Canada."
At least eight other states—including Maine, Vermont, and Colorado—have implemented laws authorizing a drug importation program and are aiming for a green light from the FDA.
"The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” FDA Commissioner Robert Califf said in a statement Friday. "These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs."
The powerful pharmaceutical industry, which has spent billions of dollars on lobbying over the past decade, is sure to fight tooth and nail to prevent the widespread adoption of importation programs—as it does with virtually every government effort to rein in drug costs.
David Mitchell, the founder of Patients for Affordable Drugs, wrote Friday that Florida's program "is a reflection of the fact that U.S. prices are too high and Americans need relief."
"But state-by-state importation from Canada isn't workable for all of us," argued Mitchell, a cancer patient who relies on drugs that cost hundreds of thousands of dollars a year. "We need federal solutions that lower prices for everyone."
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