In Newsweek Op-ed, Senator Warren Praises President Biden's Action to Lower Drug Costs, Urges Americans to Fight Back Against Big Pharma's Unreasonable Drug Prices

Op-Ed

Date: Dec. 14, 2023
Location: Washington, DC
Issues: Drugs

"This year, nearly 300,000 Americans were diagnosed with prostate cancer. That's 300,000 daddies, brothers, and best friends who got hit with sledgehammer news that they have cancer. Then came the second sledgehammer--the cost of treatment. A drug called Xtandi could save their lives, but the price runs up to $190,000 a year. It's a familiar story -- a diagnosis could force a family into bankruptcy to save the life of someone they love, while a giant drug company rakes in huge profits from every desperate patient.

Last week, the Biden Administration confronted Big Pharma by announcing a plan to allow the government to let more competitors manufacture a drug if taxpayers supported the research that helped develop it -- and if the company holding the patent has jacked up the price so high that patients couldn't get access. This action could slash drug prices for millions of Americans. Drug companies are already fighting the plan tooth and nail, but the President should not waver. He should follow through by finalizing the plan and lowering drug costs.

Xtandi is a poster child for how Big Pharma rips off Americans. All three of Xtandi's patents acknowledge that federal dollars supported development of the drug. Taxpayers also funded research that led to treatment for Hepatitis C, medicines to prevent HIV, and the technology that underlies Moderna's COVID-19 vaccine. Those drugs are just the tip of the iceberg. According to one study, every new drug approved between 2010 and 2016 benefited in part from federal funding.

American taxpayers pay to help develop these drugs, but pharmaceutical companies have free rein to charge whatever prices they want. And just to show what chumps Big Pharma makes of Americans, Astellas -- the company that manufactures Xtandi -- charges US customers as much as six times more than patients in other countries. Big Pharma makes record profits while millions of Americans suffer. It's no surprise that Democratic and Republican voters alike are demanding relief from skyrocketing drug prices.

For years, cancer patients and advocates pleaded with the government to use a tool that has been around for decades: the Bayh-Dole Act. Using "march in" rights granted by this law, the government could re-license patents for inventions that benefited from taxpayer dollars if those inventions aren't made available to the public on "reasonable terms." Cancer patients have rightly argued that demanding $190,000 a year for a life-saving drug is not "reasonable."

The government should've used its march in rights long ago, but pharmaceutical companies have lobbied to exclude a drug's price from the determination of what's "reasonable." They argue that evidence from legal scholars and others to the contrary should just be ignored.

In March, the government rejected a march-in petition for Xtandi, but said that things were about to change. It announced plans to develop a framework that would finally--finally--implement the march-in provision of the Bayh-Dole Act and consider price as a factor.

In releasing the draft framework, the Biden-Harris administration was unambiguous: price can be considered in the government's decision to march-in on a drug. That curbs the ability of pharmaceutical companies to jack up the price of drugs taxpayers helped pay to develop.

The battle isn't over. The march in guidance isn't finalized, and it should be strengthened to make clear that a drug's price is unreasonable if Americans are forced to pay more for drugs they paid to develop. Big Pharma will also do everything in its power to prevent this plan from going into effect. But we can fight back.

Here's what comes next: the march in framework will be open for public comment until February 6. That means Big Pharma will have until February 6 to ferociously lobby our government and scare Americans into thinking that actions to lower drug prices will destroy innovation, take drugs out of circulation, and generally cause the earth to stop rotating on its axis. In that same time, I will fight to ensure the administration strengthens and finalizes this framework so Americans can have a little more breathing room when it comes to their health care costs--and I'll bring along as many people in Congress as possible.

But the real fight will play out with all of you. If Americans weigh in at Regulations.gov, then all the lobbying from Big Pharma won't make a dent. This is the moment to tell our government that we're sick of Big Pharma picking up drugs that we paid to develop and then charging Americans significantly more for those drugs than they charge patients abroad.

For everyone who is battling cancer or another disease, this is the moment. For everyone who knows someone who needs access to a high-priced drug that your tax dollars helped develop, this is the moment. And for everyone who is just plain sick of Big Pharma ripping off our nation, this is the moment. We can speak up online and participate in the public comment process to tell our federal government that Big Pharma has had its day and its gargantuan profits, and now it's time to make government work for the American people. This is a righteous fight."


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