Biden Administration Won’t Use March-In Rights On Prostate Cancer Drug

President Joe Biden’s administration has decided not to pursue untested legal strategy that can dramatically reduce costs of drugs for prostate cancer patients, anger key member of parliament who is afraid of the punting administration in challenging the power of the pharmaceutical industry.

Patient advocates and progressives have hope administration will use its executive power to enable production of a generic version of Xtandi, a prostate cancer drug developed with federal funding at UCLA. The drug maker 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.

These prices impose a significant financial burden, sometimes crushing some patients, and also incur costs for the federal government. And lawyers say it doesn’t have to be that way.

Specifically, they want the administration to use the authority in the 1980 law to “march in” and demand your rights for drugs developed with federal research funding if the drug company does not make them “available to the public on reasonable terms.” In that case, the government could license the production to another company or, in theory, produce the drug itself.

The 1980 law was known as “Bayh-Dole” and was named for its co-sponsors, the late Sens. Birch Bayh (D-Ind.) and Bob Dole (R-Kan.). By using Bayh-Dole to force down the price of Xtandi, advocates hope, the federal government will exercise its ability to force down the price of other expensive drugs — or at least threaten to do so, prompting the drug’s makers to lower their prices. own

But the Biden administration refused to take that opportunity. The petition went to the National Institutes of Health, which in a letter released Tuesday said it “doesn’t believe the use of the march-in authority will be an effective way to reduce drug prices.”

The NIH has rejected march-in applications before, during the Obama and Trump administrations. Francis Collins, former NIH director the owner advise the Biden administration on science policy, already witness before he does not believe that Bayh-Dole allows the federal government to license production just because the drug is expensive.

But what is Bayh-Dole to do or not to allow remains the subject of intense dispute, both within the government and without. And in the joint news release announcing the decision, Secretary of Health and Human Services Xavier Becerra and Secretary of Commerce Gina Raimondo announced that a working group with representatives of several agencies will study the question in depth.

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

Those assurances did not sit well with prominent progressive lawmakers, such as Rep. Lloyd Doggett (D-Texas), who has push use the march-in authority as a way to fight high drug prices.

“The current three administrations are ignoring the pleas of prostate cancer patients asking for relief from Big Pharma’s price on Xtandi,” Doggett told HuffPost. “The indifference shown to this appalling abuse will be seen in the working group tasked with limiting existing statutory authority to protect American taxpayers and patients from monopoly pricing. There is no lack of clarity, no need for a working group; All we need is this Administration have the will to protect America rather than Big Pharma.

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

Administration officials said the decision to deny the petition came from the NIH, which operates as an independent agency. He also pointed to the working group — and the fact that he left the door open to using march-in powers in the future — as evidence that he’s willing to talk to the drug industry that he wants to avoid about how best to use the government. influence to reduce prices

“We think there is room to participate here, which does not mean that there are no trade-offs that we would not like, but we do not buy the argument that it is irresponsible to even talk about it because of the weakness of investors kneeling in the pharmaceutical industry,” said an administration official senior, who requested anonymity to speak candidly. “It shows that we’re taking the idea seriously and starting to pursue it in a way that the federal government doesn’t.”

It is not clear how long the working group will deliberate or how seriously it will tackle the underlying, highly complex problem – among them, whether the Bayh-Dole exercise will reduce future investment in the drug industry by reducing the profit potential.

Opponents of federal intervention have warned this thing possibility, said it will lead to less innovation and less cures. Proponents have argued that the argument overblown or just wrong.

This is the same argument hung on debate through the prescription drug reform of the Inflation Reduction Act, which would punish drugmakers for large annual price increases and give the federal government the power to negotiate some of the most expensive drugs Medicare buys.

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

“As we’ve known since 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 working on a governance approach informed by stakeholders and the public to update the framework for when and how this authority should be used.”

This record is one of the reasons that champions of march-in rights, such as Alex Lawson, tempered, or at least modulated, criticism of the announcement in Xtandi.

Lawson, executive director of the progressive group Social Security Works, told HuffPost he was “very angry” at the decision, which he considered “cowardly.” At the same time, he said that the reality is that the administration will talk about the issue, and he rejected the idea that Biden is backing down from fighting the drug companies.

“We didn’t accelerate as much as I would have liked,” Lawson said. “There’s been no change in trajectory. The Biden administration continues to see falling drug prices as a core part of what it’s all about [the administration] send it to the American people.”

However, some progressives worry that the job will continue to be short. Some worry about the possibility of a Republican administration picking up the baton in 2024 and killing the idea, just as the Trump administration did. Others wondered what role Raimondo might play. While Becerra was a strong supporter of marching rights during his time in Congress, the more moderate Raimondo has a poor track record on the issue.

The pharmaceutical industry, for its part, celebrated the administration’s decision as a clear victory, as it tracked previous NIH decisions.

“Hopefully, this puts the nail on the coffin of this canard,” said Joseph Allen, executive director of the Bayh-Dole Coalition, which includes PhRMA and biotech companies. “NIH deserves a lot of credit for withstanding tremendous political pressure to misuse the law. Granting this petition will improve the research, development, and commercialization system that supports millions of U.S. projects and makes America the most innovative nation in the world.

Patients who submit petitions to NIH formal appeal decision this week.

Meanwhile, with this latest decision, Japanese drug maker Astellas can continue to sell five times as much Xtandi in the United States as it does in Canada.

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

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

CORRECTION: This article has been amended to clarify that the Bayh-Dole law is about ensuring that drugs developed with federal funding are “available to the public on reasonable terms.” It also now includes more detail on the Bayh-Dole Coalition’s relationship with the drug industry.