Transcript: Drug shortages Q&A by Sen. Tom Carper

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. Thomas Carper (D-Del.):

Sen. Thomas Carper (D-Del.) IMAGE SOURCE: finance.senate.gov

Sen. Thomas Carper (D-Del.):

“Good morning. How’s it going so far?”

 

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

“Very well, thank you.”

 

Sen. Thomas Carper (D-Del.):

I have a question – actually two questions if we have time. I’d like to start off with a question to you, Dr. Cobb, first. As you may know, Delaware is, I think, considered by many one of the leading states that are engaged in cancer research.


“Delaware’s cancer mortality rate, when I was governor, was extraordinarily high – frighteningly high. We worked very hard those eight years in and continued since to bring them down and now they’re dropping faster than, I believe, just about any other state in the country. I think we got more than twice the national rate.

“As much as we were alarmed by where we were 15 years ago, we’re now very much encouraged. Recently, the Helen F. Graham Cancer Center in Delaware was chosen to be one of the 16 sites in the National Cancer Institute’s Community Cancer Center Program. I’m proud to say that the approval rate of patients into clinical trials in Delaware is 26% – that’s more than seven times higher than the national average.

“Now despite the strides that the researchers are making there in my home state in cancer care, physicians have expressed the concern that drug shortages are hampering their clinical trials. They said that they’re unable to enroll new patients into trials when drug supply is not assured, and they’re concerned about compromising the results of the clinical trial when they have to substitute one drug during the trial.

“I’d just ask if you might describe for us the options that a doctor might have when overseeing a clinical trial where a necessary drug in the trial becomes in short supply and what are the costs associated with this and how might it set back cancer research if a trial is compromised or has to be restarted due to a drug shortage. Thank you.”

 


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

“First of all, senator, Delaware should definitely be commended for its excellent track record of putting patients on clinical trials. That’s an impressive improvement.

“Clinical trials are really the only way we can improve the outcomes on cancer patients. We’ve seen over the last two decades a marked improvement in the outcomes for cancer patients. And it’s really because of the clinical trial network that’s been put in place by the National Cancer Institute, by the pharmaceutical companies, that are able to test new drugs against the previous standards. When we don’t have access to the generic drugs or the drugs that are in short supply, it makes it very difficult to do these types of trials. And if you can’t do these types of trials, then progress in the war on cancer tends to grind into a halt.”

 

Sen. Thomas Carper (D-Del.):

“As a practical matter, what happens when there is a shortage in…?”

 

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

“Well, if there’s a shortage and a patient stands to be a good candidate for a clinical trial, often times you can’t put them on it because let’s say a patient is on a clinical trial involves Carboplatin but I can’t get Carboplatin…”

 

Sen. Thomas Carper (D-Del.):

“Involves what?”

 

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

“Carboplatin, one of the chemotherapy drugs. If Carboplatin is not available then you’d look at this patient and say well I can’t treat this patient on the clinical trial so I have to give them something else – an ad hoc regimen. So that regimen might not be as effective and plus you’ve lost the opportunity to gain more information about how to treat cancer because they can’t enroll in a clinical trial.”

 

Sen. Thomas Carper (D-Del.):

“Thanks for that response. Dr. Thompson, if I could ask a question of you. You mentioned, I think, in your testimony that there are a number of factors that can play a role in causing drug shortages. The economic, scientific, and logistical factors leading to drug shortage can vary among different sectors of the pharmaceutical industry.

“We know that in particular quality issues and the lack of manufacturing capacities are significant drivers in causing shortages but the Medicare reimbursement rates, products discontinuation, and shortages may be contributing to the problem as well.

“We’ve heard about solutions ranging from increasing reporting requirements on drug manufacturing to increasing reimbursement rates for certain drugs and creating tax incentives to increase production capacity. You’ve all talked about some of that here today.

“When you consider the policy recommendations for addressing the complex nature of drug shortages, what solution do you view as the first priority or do multiple solutions to address the various facets of this problem need to be implemented at pretty much the same time for us to be able to guarantee significant improvements in the availability of these drugs?”

 

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

“That’s a very good question. It’s outside the jurisdiction of this committee, I know. But really the current legislation that’s pending Congress that would require notification to the FDA confidential notification so that they can help manufacturers resolve quality problems and help manufacturers who want to get into business do that. They have a track record of that. 101 times of that in two years – they’ve been able to prevent a shortage from happening by helping a manufacturer fast-track an ANDA through the Office of Generic Drugs or help deal with the quality issue much quicker.

“We think it’s a parallel process that needs to occur. I think it’s very important. And again, I’ve been working on this for a decade now and economic incentives have not been discussed over that period of time. Those need to be discussed more thoroughly and we do think that there are…”

 

Sen. Thomas Carper (D-Del.):

“Really? So in that entire decade, economic incentives have not been discussed?”

 

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

“Sir, drug shortages haven’t gotten to this level of discussion over the time that we’ve been working on. There’s always been drug shortages but the volume and types of shortages that exist now, so it’s appropriate that more serious consideration is being given to these areas. But we think it’s a parallel process. We don’t have a lot of time to wait. We think the manufacturing issues, the regulatory issues that are in the current legislation need to be addressed now and economic factors need to be looked at at the same time very seriously.”

 

Sen. Thomas Carper (D-Del.):

“All right. Anybody else on the panel want to respond to that same question? All right. Thanks very much. Thanks to all of you for being here and for your input.”

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One Comment on “Transcript: Drug shortages Q&A by Sen. Tom Carper

  1. Pingback: FDA approves emergency importation of cancer drug to ease shortage | What The Folly?!

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