Senator Marshall Questions Witnesses at Senate HELP Hearing

Washington - On Thursday, U.S. Senator Roger Marshall, M.D. (R-Kansas), questioned witnesses Dr. Brian Miller, Associate Professor of Medicine at John Hopkins University, and Dr. Ryan Long, Director of Congressional Relations and Senior Research Fellow at the USC Schaeffer Institute at the Senate Health, Education, Labor, and Pensions Committee hearing focused on making medicines more affordable through competition.

Senator Marshall's questioning focused on concerns over the growing financial strain on community pharmacists driven by pharmacy benefit managers (PBMs) and called for meaningful PBM reform to bring down prescription drug costs for patients.

Click HERE or on the image above for Senator Marshall's full remarks

Highlights from the hearing include:

Senator Marshall: "Thank you, Mr. Chairman, and welcome to our guests as well. Mr. Chairman, I noted in the audience that we have some of my community pharmacists from back home, and I bet some of your community pharmacists have been in to see you as well. I've never met a finer profession, and in so many rural towns in Kansas, they're the last healthcare professionals standing. And the PBMs are running them out of town, breaking them financially, oftentimes, clawing back more money than what the pharmacist is able to stock the medicine for. In our appropriations bill, on a bipartisan basis, we nipped at the edges of PBM reform. There's still much to be done, but one of the things my pharmacist brought to my attention was the relationship between TRICARE and Express Scripts. And I don't know how long they've had that contract, maybe since the early 2000s. Mr. Long, would an audit be helpful? Should it be demanded of TRICARE? I can't imagine the money we're wasting. What my veterans tell me is they get a 90-day supply of a medicine that they, you know, they may not. Any concerns with any advantages of an audit on TRICARE and Express Scripts?"

Dr. Long: "I don't know that there can ever be a disadvantage to an audit. I think transparency is a good thing, no matter the course, no matter the event."

Senator Marshall: "Great. Mr. Chairman, I don't know who we asked to do that, if we asked our inspector general at HHS, or if it's a VA thing, but I sure hope this committee would get behind that in some way, somehow as well. Let's go to Dr Miller next. Certainly, the people that struggle to get their drugs approved blow up my office, but then I dig down with the FDA a little bit, and they're approved in record numbers, and they're doing more with less. Are you aware of any data points or how the FDA is doing compared to previous administrations on approving drugs?"

Dr. Miller: "I think the FDA has worked to accelerate the review process and make it more efficient. My position is, we can take that and do even more, and if you look at it, in the Office of New Drugs, there are around 340 drug reviewers, and there is something like 6,000 people in the Center for Drug Evaluation and Research. There are 12 major offices, two of them are primarily involved in drug review, some of the others support, and then there's a lot of other bureaucracy."

Senator Marshall: "What keeps that from happening? I've been here nine years in Congress now, and we knew it was a problem nine years ago. Is it? Is it the swamp? Is the bureaucracy? What can we do specifically with biosimilars to make it more efficient?"

Dr. Miller: "So for biosimilars, that abbreviated biologics license application, updating 351k to make it more like an ANDA is one thing we can do for biosimilars, for branded products, I think healthy oversight of the FDA and very in the weeds, detail about their structure and how they do product review. I think we could use that to restructure drug review, strengthen the standards for safety and efficacy while lowering the cost of market entry."

Senator Marshall: "Okay, Mr. Long, I'm going to come back to you and talk about biosimilars and PBMs, but I still think it's important to look at the big picture here. The big picture is Americans spend 75% of their money on prescription drugs, on chronic diseases. 75% of their money is on chronic diseases. The number one thing we could do to drive down the cost of prescription drugs is to have a healthier America, right? So we spend all of our time nipping at the edges again of drug prices, but we need to continue to have a focus on making America healthy again, and I think we have to acknowledge that prescription drugs, to some extent, to a large extent, keep people out of emergency rooms, out of hospitals. So, there is value in those drugs. If you want me to save Medicare, I need an Alzheimer's drug to start with. So, I think that we have responsibilities. As you know, people across America are expecting Congress to fix this all the time, but I want to talk about biosimilars and PBMs, and what my pharmacists have told me is that they have to raise the prices on biosimilars to be able to gain access to the formularies. Just talk a little bit about that game that the PBMs are doing for formulary access for biosimilars, if you can."

Dr. Long: "In my testimony, I mentioned both the Viatris insulin and Humira. And what happens is, in order to get on formulary, you must provide rebates. So. In the insulin example, in 2020, they had a biosimilar that they couldn't get on any formularies. 2021, they got a biosimilar, an interchangeable biosimilar approved. They actually had to launch two different products. It was the same exact drug, same exact biologic, one with a list price that was triple the A price that someone could go into a pharmacy and get, and that was in order to provide rebates to get on formulary."

Senator Marshall: "Yeah, and just to sum that up, that the problem is, the higher the cost of the drug, the more money the PBM makes. That's why we need to de link those two to win this ball game."

Dr. Long: "I think what Congress did last year is a great first step."

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