Biden administration bets on chance to make cancer drug cheaper

The administration of President Joe Biden has decided don’t chase an unproven legal strategy that could lower the cost of drugs for patients with prostate cancer, angry key legislators who fear the administration is betting on challenging the power of the pharmaceutical industry.

Patient advocates and progressives had expected the administration would use its executive powers to enable the production of generic versions of Xtandi, a federally funded prostate cancer drug developed at UCLA. The drug’s manufacturer charges up to $190,000 a year for the drug in the United States, while charging a fraction of that price in other developed countries.

That price imposes a significant, sometimes crushing, financial burden on some individual patients, while significantly increasing costs for the federal government as well. And advocates say it doesn’t have to be that way.

Specifically, they want the administration to use its authority under a 1980 law to “enter” and claim rights to drugs developed with federal research funds if the pharmaceutical companies do not make them “available to the public on reasonable terms.” In such cases, the government can grant production licenses to other companies or, in theory, produce the drug on its own.

The 1980 law is known as “Bayh-Dole” and is named after its cosponsors, the late Sens. Birch Bayh (D-Ind.) and Bob Dole (R-Kan.). By using Bayh-Dole to force down the price of Xtandi, proponents hoped that the federal government would establish its ability to force down the price of other expensive drugs, or at least threaten such action, pushing drugmakers to lower prices on their products. own.

But the Biden administration refused to seize that opportunity. The petition had gone to the National Institutes of Health, which in a letter published Tuesday said it “does not believe that the use of marching authority is an effective means of reducing the price of the drug.”

The NIH has denied entry applications before, during the Obama and Trump administrations. Francis Collins, the former NIH director who has advised the Biden administration on science policy, has previously testified he doesn’t think Bayh-Dole allows the federal government to authorize production simply because a drug is expensive.

But what Bayh-Dole allow or not allow it remains the subject of intense disputes, both within and without the government. and in a joint Press release Noting that decision, Health and Human Services Secretary Xavier Becerra and Commerce Secretary Gina Raimondo announced that an existing task force with representatives from various agencies would study the issue further.

“The Biden-Harris Administration is committed to increasing access to health care and reducing costs,” Becerra said. “And the gear authority is a powerful tool designed to ensure that the benefits of American taxpayer investment in research and development are reasonably accessible to the public.”

Those assurances did not sit well with prominent progressive lawmakers, such as Rep. Lloyd Doggett (D-Texas), who have been entrepreneur use marching authority as a way to fight high drug prices.

“Three administrations have now ignored the urgent plea of ​​prostate cancer patients seeking some relief from Big Pharma’s price gouging for Xtandi,” Doggett told HuffPost. “The indifference shown to this outrageous abuse will likely be reflected in the task force charged with limiting its own existing legal authority to protect both American taxpayers and patients from monopoly pricing. There is no lack of clarity, there is no need for a working group; all that is required is for this Administration to have the will to protect Americans instead of Big Pharma.”

James Love, director of International Ecology Knowledge and brother of one of the patients who filed the petition, called the response “appalling and insulting.”

Administration officials said the decision to reject the petition came from NIH, which operates as an independent agency. They also pointed to the task force, and the fact that they have left the door open for future use of marching authority, as proof that they are willing to have a conversation that the pharmaceutical industry desperately wants to avoid about how best to use government. leverage to lower prices

“We think there’s room to participate here, which isn’t to say there aren’t tradeoffs we don’t like, but we don’t buy the argument that it’s irresponsible to even talk about this because of weakness. investors on their knees in the pharmaceutical industry,” said a senior administration official, who requested anonymity to speak candidly. “It reflects that we are taking the idea seriously and starting to deal with it in a way that is not where the federal government has historically been.”

It is unclear how long the task force will deliberate or how seriously it will address underlying and substantively complex issues, including whether the Bayh-Dole exercise would discourage future investment in the pharmaceutical industry by reducing profit potential.

Opponents of federal intervention have warned about this possibility, saying it would lead to less innovation and fewer cures. Supporters have said those arguments are withered either just wrong.

These same arguments hung over the debate on the Reducing Inflation Act prescription drug reforms, which will penalize drug makers for large annual price increases and give the federal government bargaining power over some of the most expensive drugs Medicare buys.

Biden, who signed the Inflation Reduction Act into law last year, was a strong supporter of those reforms, a point administration officials emphasized in response to criticism of Tuesday’s announcement.

“As we have made clear from day one, the Biden-Harris Administration is committed to lowering health care costs and expanding access to care for all Americans,” said Kamara Jones, a spokeswoman for the Department of Health and Human Services. “We are seeking a whole-of-government approach informed by stakeholders and the public to update a framework for when and how this authority should be used.”

That record is one reason longtime champions of marching rights, such as alex leysonmoderated, or at least modulated, his criticism of the Xtandi ad.

Lawson, the executive director of the progressive group Social Security Works, told HuffPost that he was “incredibly angry” about the decision, which he chalked up to “cowardice.” At the same time, he said that the simple fact that the administration will speak on the issue equals progress, and rejected the idea that Biden was backing down from fighting drug companies.

“We didn’t accelerate as much as I would have liked,” Lawson said. “There has not been a change of trajectory. The Biden administration continues to view lower drug prices as a core part of what (the administration) offers the American people.”

Still, some progressives are concerned that the ongoing job is too little. One worried that a Republican administration would take over in 2024 and kill the idea altogether, as the Trump administration tried to do. Others wondered what role Raimondo could play. Although Becerra was a supporter of marching rights when he was in Congress, the more moderate Raimondo has less background on the subject.

The pharmaceutical industry, for its part, hailed the administration’s decision as a clear victory, saying it followed past NIH rulings.

“Hopefully, this puts the nail in the coffin for this hoax,” said Joseph Allen, executive director of the Bayh-Dole Coalition, which includes PhRMA and biotech companies. “NIH deserves a lot of credit for standing up to the incredible political pressure to misuse the law. Granting this petition would have upended the research, development and marketing system that supports millions of US jobs and makes America the most innovative nation in the world.”

The patients who filed the petition with the NIH officially appealed this week’s decision on Thursday.

Meanwhile, with this last sentence in hand, Japanese drugmaker Astellas can continue to sell Xtandi for five times as much in the United States as it does in Canada.

Sen. Bernie Sanders (I-Vt.), who chairs the Senate Committee on Health, Education, Labor and Pensions, said in a statement that he would “confront the greed of the pharmaceutical industry and ensure that drugs developed with the US. taxpayer money is sold here at a reasonable price.”

“How many prostate cancer patients will die because they cannot pay this unacceptable price?” Sanders asked.

CORRECTION: This article has been edited to make it clear that the Bayh-Dole law is about ensuring that drugs developed with federal funds are “available to the public on reasonable terms.” It now also includes more details about the Bayh-Dole Coalition’s links to the pharmaceutical industry.