Drug Shortage Dilemma: Prevention -- In Depth Doctor's Interview
Joseph Hill, Director of Federal Legislative Affairs, discusses new legislation concerning drug shortages in the United States.
Why are we seeing such a spike in drug shortages these days?
Joseph Hill: Well, there are a number of factors that lead to drug shortages. We have seen everything from the availability of raw materials, to industry consolidation, and also product quality issues. Most of the shortages are in the generic sterile injectables and the manufacturing processes for those types of products are quite complex.
That has been affecting more than just patients, correct? It affects hospitals?
Joseph Hill: Absolutely. Our members are scrambling to try and find the product, and often times they are spending more time locating the product than they are caring for the patients.
Now, that basically costs time and money?
Joseph Hill: Absolutely, we conducted a survey last year that found that roughly $216 million is being spent nationwide just to try and locate the products that are in short supply.
Can you find them overseas?
Joseph Hill: You could. In some cases, it is sort of a last resort for the FDA to allow a company to import a product from, say, a European source to get a temporary supply of the product until manufacturing capacity in the U.S. can be brought up to speed.
Is there any way that the physician could do that without going through the FDA?
Joseph Hill: No, current law only allows manufacturers to import product with the approval of the FDA.
Because there have been so many shortages, I read an article about paramedics using expired drugs. Is that a possibility?
Joseph Hill: We have heard that in some cases, EMS or first responders are taking a little bit of a chance and using products that maybe beyond their expiration date in certain cases, but our understanding is those are only in cases where the choice is either the patient is going to die or you risk giving them the outdated product.
In February the U.S. government allowed shipments of drugs from India and Australia to fill in the gap. How much is that helping?
Joseph Hill: It is helping. In certain cases the FDA will allow temporary importation of a drug and that enables the supply to continue while the U.S. manufacturing capacity can be brought back online.
Are those drugs really helping patients today?
Joseph Hill: Yes. In one case, the FDA allowed the importation of methotrexate, which is a cancer drug. They allowed a 2 to 3 week supply to come in from an Australian source while American companies got their production capacity back online.
Who should take the blame or most of the blame for the shortages?
Joseph Hill: Well, one thing we have not seen is a bad guy. We have seen a number of different factors contributing to drug shortages and in particular, the quality issues in the manufacturing. We have not seen any evidence to suggest that there is any market manipulation. It is just rather these products are very difficult to make. You have to be 99% right because it is going into someone’s vein and often times if a manufacturer has any question about the integrity of the product, they are going to stop their production of it to investigate the problem and then to correct that problem. That often takes time and sometimes it results in a shortage situation.
President Barack Obama signed a bill that passed into law in July. Why did it take so long for something like this to become a law?
Joseph Hill: I think there were five hearings conducted by Congress on both sides; the House did 2 hearings, the Senate did 3 hearings. So, I think there was a lot of investigation on how can we correct this problem, what are the best steps to take, and how do we approach it in a thoughtful manner and not make the situation worse.
Can you talk a little bit about the law?
Joseph Hill: The main element in the drug shortages provision of the FDA User Fee law is an early notification requirement. So, a company producing prescription drugs in the United States must notify the FDA as soon as possible whenever they shut down production due to a quality issue. If they are discontinuing a product, they must notify the FDA within 6 months of that discontinuation. That, in turn, will enable the FDA to work behind the scenes with other manufacturers to ramp up production or expedite approval or in certain rare circumstances allow another company to import temporary supplies until the U.S. capacity is up and running.
If they don’t then there is a penalty, correct?
Joseph Hill: Well, the law has no civil monetary penalties. Instead, if a company fails to comply with the early notification requirement, it receives an automatic letter from the FDA asking why it failed to comply and the company must respond to that letter within 30 days.
Do you see a lot of patients going through this right now? What can they do?
Joseph Hill: Well certainly. We are urging patients to constantly communicate with the physician, with all of their caregivers. Obviously, there is a lot of concern out there, especially among cancer patients, that they will not get the treatment that they need. So we are urging them to constantly communicate with their physician and their physicians in turn are working with other members, including pharmacists, to try and locate the necessary medications.
How much do you think that politics play into the prescription drug problem?
Joseph Hill: We have not seen any evidence that shortages are the result of any political manipulation. Obviously, there are some folks that think that there are economic causes to drug shortages. We simply do not have any data to suggest that economics is playing a role. We would like to investigate that further, but we need to be careful that we are not providing economic incentives to create shortages in the first place. So, I think we really want to gather some more data before we go down that route.
What should Congress do versus what the FDA should do to help with the problem?
Joseph Hill: Well, Congress certainly took an important first step in enacting the User Fee legislation earlier this year. This is going to enable the FDA to compile information about manufacturing capacity and be able to work behind the scenes to ensure that the necessary supply of products is not interrupted. In the meantime, we think that Congress can work with other agencies such as the Drug Enforcement Agency to examine whether controlled drug quotas are actually exacerbating the shortage of controlled drugs, but for the most part Congress has taken a critical first step.
Do you have any idea how many deaths are associated with the drug shortage right now?
Joseph Hill: I do not think we have a set number of deaths. I think I have heard somewhere around 15 deaths associated with drug shortages, but it is very difficult to run across any data or any studies that have examined exactly how many deaths are due to drug shortages.
What is next? Who should take the blame? What can patients do to protect themselves?
Joseph Hill: Certainly patients should be talking to their doctor. They can be monitoring our website as well as the FDA’s website if they think that any medication that they are on may go into short supply. The FDA is already working very hard with the manufacturers to ensure that the manufacturing capacity is up and running. Certainly, Congress has taken that first step in giving the FDA some additional tools that it needs. We are already seeing a downward trend in the number of new drug shortages, so we have got less this year than we had last year. We are certainly not out of the woods yet, but it is a good trend and it is something that we want to continue.
How much money do you think that we would save if this problem was solved completely?
Joseph Hill: That is a good question and it is a difficult one to answer. Certainly we know the labor costs involved in tracking down product, which we have estimated at $216 million nationwide, but we do not know the out-of-pocket costs that consumers may suffer as a result of having to go with second line treatments that may not be covered. So that is certainly difficult, but at least from what we can tell on the labor cost side, those are significant costs to the system. I think I would just make the point that in a year when the two parties are just not cooperating and there is such a partisan tenor down on Capitol Hill, it was refreshing to see that this bill passed with widespread bipartisan support. It may be one of the few things that passes this year.
Would it be better if there were more than one company in this country that was making this same drug? Would that help?
Joseph Hill: Well, certainly, I think that in some cases it would definitely help if there were more than one manufacturer. I think another point to make is that in the newly enacted law the FDA has the ability to provide expedited review of products. So, there may be applications that are on the books or in someone’s in-box in the FDA that simply are not being acted upon, but these are applications to make a generic product. The other element of the User Fee Act is there is now a generic user fee program. So a generic company, just like a brand company, will now pay the FDA to have the agency review its products. This will help to alleviate the bottleneck of new applications that the FDA has to review. Because it is a new revenue source, the FDA is going to be able to hire additional reviewers so our hope is that this will greatly reduce the time it takes for a manufacturer to begin to make a drug because the FDA will have to obviously approve that application.
It seems to me like there are too many regulations. The FDA has to go through so many different hoops and steps to be able to approve something. Could that be also contributing to it?
Joseph Hill: We have not seen that as much as we have just the sheer number of applications and not enough people to be able to review them. So because of this legislation, it opens up a new revenue stream and the FDA is going to be able to hire additional reviewers to review those applications. Our hope is that we are gradually going to see an increase in the number of manufacturers of many of these medications. I would reiterate that it is almost like the 5 second rule with a cookie; it hits the floor, oh that is fine, a 5 second rule with the pills, probably not going to harm you. A 5 second rule with something that is going directly into your vein that could potentially kill you, so really the stakes are high when we talk about the quality of the products.
In Europe everything gets approval faster.
Joseph Hill: I would add another contributing factor to shortages is the increased demand for these products.
The increased demand, does that mean that we are getting sicker?
Joseph Hill: Well, we are getting older. As we get older, we get sicker, so I think the aging of the population means more people are getting sicker as they get older. I think we are also doing more preventative services. We are identifying conditions or diseases a lot earlier than we were, so you see more and more treatments with medication rather than surgery. If you look at the screening, people are getting their screenings done earlier and earlier and the screenings are better able to detect a potential problem. So, we see more and more cancer diagnoses being done earlier in the process and I think that also contributes to the increase in demand.
Some companies, those making blood disease drugs for example, do not have to warn the FDA when there is going to be a shortage, correct?
Joseph Hill: Well, in the final bill, it is left to the discretion of the FDA to include it. So for example, biological products, technically they are not included in the bill and neither are blood products, but the FDA can determine that if it is necessary to include those within the early warning requirement they can do so if need be. In our discussions with FDA, they have indicated to us that they have every intention of including those products within the early notification requirement.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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If you would like more information, please contact:
Joseph M. Hill
Director, Federal Legislative Affairs
American Society of Health-System Pharmacists
To read the full report, Drug Shortage Dilemma: Prevention, click here.