Transcript of Q&A by Rep. Elijah Cummings on the drug shortage crisis

House Oversight and Government Reform Committee 

“Drug Shortage Crisis: Lives are in the Balance” hearing held on Nov. 30, 2011 by the Subcommittee on Health Care, District of Columbia, Census, and the National Archives

Transcript of Q&A by Rep. Elijah Cummings (D-Md.):

Rep. Elijah Cummings (D-Md.). IMAGE SOURCE: oversight.house.gov

Rep. Elijah Cummings (D-Md.):

“Thank you very much. As most of you know, since this summer I’ve been looking into the so-called “gray market” during drug shortages. My investigation has focused on determining where some of the companies obtained drugs in critically short supply and how much they mark up the drugs that they sell to hospitals and other health care facilities.

“My staff has heard from countless health care providers about the constant, unsolicited offers for drugs on the shortage list but at prices that are nothing short of price gouging. For example, one company offered to sell a cancer drug for over $990 per vial, more than 80 times the hospital normally pays for it. I recognize the incredible predicament that this puts our health care providers in. I do not envy their choices of either delaying or denying treatment until drugs become available from a reputable distributor or paying huge mark-ups on the drugs.


“Dr. Hudspeth, by the way, I really appreciate your passion. I feel it. When your hospital no longer has the needed drugs available, what steps does your hospital undertake to obtain a needed drug? And I’m very familiar with chemotherapy. It’s done in cycles. So I guess you might have enough to start a cycle, but not enough to finish a cycle. So I guess you don’t start it – is that how it works?”

 

Dr. Michelle Hudspeth, Division of Pediatric Hematology/Oncology of Medical University of South Carolina:

“That’s correct. Basically, part of our committee meeting each week is looking at who throughout the institution is due for what and how much that will entail and how much supply is on hand.

“Our institution does not deal with the gray market. We’ve certainly been approached; our policy [is] we do not deal with them.

“I’m continually indebted to the wonderful pharmacists at our institution that spend an amazing amount of time speaking with manufacturers, trying to get drugs. It’s really been an all out effort.”

 


Rep. Elijah Cummings (D-Md.):

“Do you think you have a lot of other health care facilities in, say, South Carolina that refuse to deal with the gray market?”

 

Dr. Michelle Hudspeth: 

“It’s hard to say. I could see how the pressures could get to you. It’s very easy to say, ‘Sure, we don’t want to deal with the gray market.’ But at the end of the day, when you know that there’s a patient on the other end, you could see where that temptation could come along. So I don’t know of any instances for sure but I know that the threat is out there.”

 

Rep. Elijah Cummings (D-Md.):

“To all of our witnesses, can you explain to me how it would be potentially harmful for a patient to be given a drug that has changed hands many times?”

 

Ted Okon, Executive Director of Community Oncology Alliance:

“I can just say, Mr. Cummings, that the amazing thing about the distribution system is it’s very regulated and you understand the pedigree of the drug, which is very important. So the problem is when you have some distributor that you don’t know at all that basically sends a fax – I hear from practices all the time that they get faxes about drugs, that they get emails about drugs – and you don’t understand the pedigree of that. Again, I’m not an oncologist. But I think the problem is administering that drug, which I don’t think my wife would be in favor of as an oncology nurse administering that drug, without a set pedigree is very dangerous because you’re talking about extremely, extremely – potentially – toxic medication.”

 

Rep. Elijah Cummings (D-Md.):

“You know, I was just thinking, just going back to you, Dr. Hudspeth. When you got somebody with cancer and they face life or death, and the patient knows – you know, people begin to research. Do you ever come into a situation where somebody says, ‘Wait a minute, doc, we know you don’t have the drug but we’ve done some discovery here and learned that XYZ gray market company has it. We don’t care what it costs. We’ll pay.’ I mean, do you run into those kinds of situations?”

 

Dr. Michelle Hudspeth:

“It’s getting to that point. What my concern is 85% of the children I take care of are Medicaid-funded. I’m a native South Carolinian but we’re a poor state. Part of my passion is that these kids have to have treatment no matter what background or circumstances they come from. So what I’m afraid is going to set up is you’re going to set up a hierarchy of treatment. If you’ve got the money to pay or obtain some drug or travel to Canada, you can get treatment. But the folks who don’t have the finances to do that are left behind. Who’s that’s going to be? It’s going to be the kids.”

 

Rep. Elijah Cummings (D-Md.):

“Dr. Thompson, are your members concerned with the safety of such drugs that are circulated in the gray market?”

 

Dr. Kasey Thompson, Vice President of Policy, Planning, and Communications for the American Society of Health-System Pharmacists:

“Yes sir. They are. You know, this has been a phenomenon that they’ve dealt with for a very long time.

“The notion of receiving faxes came up, and this does happen. When there’s a shortage, our members get contacted with offers to provide these drugs at exorbitant prices. But it’s really not the price issue so much – not that that’s not a factor – it’s the safety issue. When everybody knows there’s a profound shortage of a drug, they’re asking the question where do these distributors get the product? Is it safe? How was it stored? What’s the pedigree? So it raises real concerns.

“Many pharmacy departments and hospitals will not buy from the secondary market at all. But as others have mentioned, sometimes there’s no other option.”

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