NIH Questioned about Xtandi and March-in Rights during Congressional Hearing

On Wednesday May 11, 2022, the National Institutes of Health (NIH) was asked about Xtandi and march-in rights during a Congressional hearing. The House Appropriations Committee held a hearing on the FY2023 Budget Request for the NIH, and Representative Mark Pocan used the opportunity to question Acting NIH Director Dr. Lawrence Tabak regarding the Xtandi march-in request and the NIH’s approach to high drug prices charged to US patients. Below is a clip of the exchange and a transcript of the conversation.

Transcript of Exchange between Rep. Pocan and Dr. Tabak

Pocan: I do want to ask Dr. Tabak a question, so, you’re a dentist in addition to being a scientist and I know that health care providers often take the Hippocratic oath or a similar commitment to medical ethics.

Do pharmaceutical companies have a similar obligation to prioritize the well being of the patients they serve, even if it means putting the greater good ahead of their own profits?

Tabak: I’m not aware of what are their standards.

Pocan: Would you think that would be a good standard?

Tabak: Of course.

Pocan: Of course – Could you say that again?

Tabak: Of course.

Pocan: Thank you. Okay. I just want to make sure I had that.

And the reason I asked that and I think I got a little ahead of myself and Dr Fauci I had answer the other question on all the money that we are NIH is providing to the promising next generation pan coronavirus vaccines, is really a question currently with a drug and I’m probably gonna kill the name because they do that to us, Xtandi, if I’m saying it correct.

So, you know, right now this is a prostate cancer medicine marketed in the US by subsidiary of a Japanese pharmaceutical company, Astellas, they charge US taxpayers and consumers 2 to 4 times the price of that than other countries. Despite US taxpayers having funded the invention of this through NIH.

Now this question is a simple real first one, has it changed in the last decade – no drug approved by the FDA has not had NIH investment. Is there a drug yet that’s approved by the FDA in recent memory that’s not had NIH investment?

Tabak: Not, not not to my knowledge.

Pocan: So specifically to this drug we’re honestly price gouging, we’re getting ripped off right and left in my opinion by pharmaceutical companies in so many cases. This drug in particular under the Bayh-Dole act, when the U.S. government and taxpayers fund an invention, we have rights to that invention including the right to march in and license competition, when the U.S. taxpayers are price gouged, you’ve gotten a letter from a number of elected officials on this drug.

But this is just one of many that I think we could point out and have a long conversation on, will you step in as NIH and be responsible stewards of the medical and pharmaceutical inventions that uses tax dollars to help develop, ensuring that taxpayers aren’t being forced to pay twice once on the front end through NIH and then once again through these higher prices, more than other people in the world.

Are you willing to start seriously looking at doing marching in rights on these types of drugs?

Tabak: So, as you know, it’s a complex space.

And up until now, neither NIH nor other agencies that have looked at this have thought that price per se met the criteria that are needed for march-in, which depend more on the availability of the drug. So for example, if there are no manufacturing plants that are available to manufacture a drug, that would be an example of perhaps where march-in would be used. In this case the the barrier is strictly a financial one.

We’re, we are just as concerned about high prices as any other person or agency, but we we need to ensure that we’re using the right tool for the right job.

The request that you refer to is under consideration. And we are looking at it both specifically and in the context of the broader plan that the department has for lowering drug prices.

Pocan: I just hope we consider this. I sat down with someone recently who every year I meet with on his particular ailment and his health is going down and down. And recently there was a drug that he told me he had to, he was considering passing up that was $50,000. He had to do twice a year for his health. And I’ve watched, you know, his condition and I just think it’s time, this is something that, again, I think down back in the future will look back why we didn’t address this. And I think we’ve had the tools to and if you need additional tools, please let some of us know. We’d love to give you those tools.