Transcript: Drug shortages Q&A by Sen. Ben Cardin

Senate Committee on Finance hearing on “Drug Shortages: Why They Happen and What They Mean” held on Dec. 7, 2011

Transcript of Q&A by Sen. Ben Cardin (D-Md.):

Sen. Ben Cardin (D-Md.) IMAGE SOURCE: finance.senate.gov

Sen. Ben Cardin (D-Md.):

“Thank you, Mr. Chairman. And let me thank all of our witnesses. I think this is an extremely important hearing. Let me just underscore the urgency of what we’re dealing with here. I’ve gotten a lot of letters and calls from constituents; I’m sure all my colleagues have gotten the same.

“Let me just quote from one of my constituents who said, “My doctor put me on Doxil and Carboplatin to try to get rid of some tumors associated with ovarian cancer that has been hanging around. I had four treatments with both drugs and was responding very, very well. I’ve now missed three doses of Doxil due to the shortage, and I am treading water with the Carbo[platin] but I’m frustrated that I’m no longer making the progress toward remission.” So we’ve talked about the number of drugs that are in shortage but each one affect some person or some family.


“I would like to just also bring up an impact that the shortage is having on clinical trials. I represent Maryland, which is home to the National Institutes of Health. And when they do their cancer trials – and there have been 150 cancer trials that are currently being conducted through NIH – they don’t use a placebo – they use a standard care drug – because of the seriousness of the care versus experimental drugs. And of course, the shortage of the standard drugs are raising questions as to the progress – and whether we should be making progress – on clinical trials, which affects the whole health care system.

“So I just really want to get to the urgency of what we’re dealing with. I understand your suggestions on a lot of the pricing issues that we have to deal with, and you’re absolutely right. Put that on the table. We have to get this right. But I want to concentrate on what we can do in the immediate future to deal with the concerns that have been legitimately raised by our constituents that their care is being compromised, and they look to us to do something about that. So what can we do now to alleviate these shortages so that our people can get the care that they need?”

 


Dr. Scott Gottlieb, Resident Fellow at the American Enterprise Institute:

“I know it’s not the purview of this committee but there is a lot of manufacturing capacity that’s currently offline and undergoing remediation by the FDA. I think getting a sense of how much capacity has been taken out of the market would be important. You can simply send letters to the top five manufacturers and ask them how much of their capacity is down. But making sure that that gets remediated as efficiently as possible and that’s brought back online with FDA working with manufacturers as quickly as possible is extremely important. There probably are steps that we could take to help the regulators make sure that there are the resources they need to get those facilities back online. In the near term, meaning the next six months, I think that that’s all that we can do. I think a lot of the discussions today was around how we can fix the market failures that permeate this area for the longer term. But in the near term, I think all we can do is try to get the production facilities that are down back online.”

 

Sen. Ben Cardin (D-Md.):

“Any other suggestions for immediate? HHS has considered emergency imports of some of these drugs. Do you all support that?”

 

Dr. Patrick Cobb, Frontier Cancer Center and Blood Institute:

“I think that in certain cases where the drug is just not available, especially for the example I gave for Cytarabine – there are no substitutes for that. So if there’s not enough manufacturing capacity in the United States to make enough, to take care of the demand, then we’d have to get it from someplace else. So that may be something to look at.”

 

Dr. Rena Conti, Assistant Professor of Health Policy and Economics at the University of Chicago: 

“Also, my understanding is that anticipated shortages in Canada have been alleviated by short-term purchases of drugs in short supply from other places, most notably Australia. I think the real downside to that just comes down to concerns about perishability and safety in transporting them overseas.”

 

Dr. Scott Gottlieb, Resident Fellow at the American Enterprise Institute:

“There are also differences in the formulations of drugs sold overseas versus the United States. For example, when there was a shortage of Propofol, the FDA authorized some limited importation of the product from Europe – a similar product – but it wasn’t the same product. It didn’t have the same ingredients that prevented propagation of infection with the product. Doctors were using a product that they thought were interchangeable but in fact needed to be used under different sterile techniques than the products that they were used to using. So importing the drugs isn’t going to be the panacea. It can create its own risks. Canada, for that matter, gets a lot of their sterile injectable drugs from the same manufacturing facilities that we get ours from, so they’ve experienced the same shortages that we have. I suspect that if we go wholesale trying to acquire these drugs overseas we’re going to find very quickly that those facilities suddenly get unavailable to us, if not, nationalized. So it’s going to create other problems.”

 

Dr. Rena Conti, Assistant Professor of Health Policy and Economics at the University of Chicago: 

“They had anticipated shortages, but apparently they have not experienced true shortages in the way in which we have, just to clarify.”

 

Dr. Patrick Cobb, Frontier Cancer Center and Blood Institute:

“I think this is a very short-term fix what you’re talking about. I mean, ultimately we have to fix the underlying problem, which is there’s not incentives for generic drug manufacturers to make these drugs.”

 

Sen. Ben Cardin (D-Md.):

“And I’ve prefaced my question by acknowledging that. I agree with you. I just would point out the urgency of this issue. And I understand the risks of importation. But it seems to me that can be dealt with in the short-term ’til at least know what we’re dealing with. And if that’s the best alternative available, it’s better than a person going without the drug and not making any progress. So I think it’s something we need to have, I guess, greater cooperation as we try to deal with the urgent issues that we have right now and then deal with supply chain for the future that we all know needs to be corrected.”

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