Dr. Kweder: You would think that if it was reduced profit margins what you would see are companies just ceasing production, but we have had very few shortages related to companies stopping production; well below ten percent. Usually when those occur there’s somebody else behind them ready to start production.

We’re talking to pharmacists about this problem and some of them say it’s just taking a lot of their time, a lot of their money, and one even compared it to a third world country. What’s your response to that?

Dr. Kweder:  This is extremely difficult. It’s difficult for us but the difficulties for FDA pale in comparison to the experience of people taking care of patients. Whether it’s clinicians who have to choose an alternative medicine or a patient who feels like they have to take a therapy that may not be as effective as what the doctor originally prescribed. The logistics for pharmacists can be a nightmare. I’ve talked to pharmacists who are pharmacists in healthcare facilities and they have up to several people working full time just to monitor where they’re going to get a supply of critical medications. That is just unheard of.

Is there any way to estimate how many people in the last five years are affected by this shortage?

Dr. Kweder:  We don’t have numbers on that but we probably should try and calculate that. My best estimate would be that it has to be hundreds of thousands to that of millions. You just look at the drugs that have been affected; some of the most commonly used medications in oncology, in anesthesia, and in medicine in general have been affected by this.

So what is the next step for the FDA in solving this problem?

Dr. Kweder: We are looking at every option we can possibly try and see what role we can have to try and address the problem. What we have seen is that a lot of the companies that have had major problems, where they’ve actually closed plants, are rebuilding those plants or revamping existing plants. We think that’s a step in the right direction and when they are doing it we are working with those companies to make sure that we’re in communication about what the plans are for quality control in the twenty-first century. Our mantra in this has been that what needs to happen is the quality has to not only be built into the facilities, it has to be part of the culture in these companies. That quality starts at the top and people have to be held accountable for quality. There are companies in other sectors of the pharmaceutical industry and many other industries in this country where quality is job one. Absolutely in every aspect of the pharmaceutical industry, particularly for these medicines that patients rely on, there can’t be any other way. That’s what we think is the long term solution. We’re not going to fix it overnight, but the industry remains healthy and we think that things will start to move in a positive direction.

The Prescription Drug User Fee Act, what is that?

Dr. Kweder:  Yes, the Prescription Drug User Fee Act is in its fifth round of existence. It gets renewed every five years where Congress passes legislation that allows FDA to collect fees for certain activities. In exchange FDA commits to certain conditions such as timelines of product reviews and implementation of specific programs. The industry has requirements as well. As part of the Prescription Drug User Fee Act this year there were the requirements for companies to report where shortages or potential shortages came from. A unique element is also the Generic Drug User Fee Act which was passed in 2012 and is new. For the first time FDA will be able to collect user fees for reviews of generic drug applications. The first order of business that FDA has under the Generic Drug User Fee Act is to eliminate the backlog of generic drug applications and supplements. If you remember I said that sometimes companies have supplemental applications to change a manufacturing procedure, site, or supplier. Those come into the generic drugs office and right now there’s a backlog of almost two years to get those reviewed. If we know that a particular application can prevent or address a shortage we pull that immediately and put it to the front of the queue, but the goal is to not have to do that, to have that backlog gone. So if there’s any role that FDA has in these shortages from being slow on reviewing these applications that will be eliminated.

Generics.

Dr. Kweder:  What the Generic Drug User Fee Act does is for the first time it allows FDA to collect user fees from the industry for certain activities related to generic drug applications. It gives FDA enormous resources for staffing in order to serve that sector of the manufacturing community and the public. What is seen as FDA’s first order of business under that act is to eliminate the backlog of generic drug applications. So now when companies tell us that they may have a shortage on their hands, we look to see if there are any applications in that queue of generic drugs that we could pull to review quickly and help prevent or address a shortage; that won’t be necessary any more. Those will already be being addressed and not an issue at all. If there’s any role for FDA in slowing down the ability to prevent a shortage or address it, that won’t be operative any longer under this act.

Where do you see this problem being five years from now?

Dr. Kweder: It’s very hard to predict. We didn’t get into this situation overnight and we’re not going to get out of it overnight, but I see the work of the industry, particularly the generics industry, to build new facilities and to begin to take quality more seriously as a really positive sign. There’s a lot of attention on it in the medical community and I think people have to keep up that tension; keep up the pressure. Americans count on and deserve high quality medications that they can obtain reliably. Who would have ever thought we would be in this position and I think that the public has a right to be dismayed and outraged and needs to keep the pressure on everyone involved, including us, to address it.

What is your personal involvement in the drug shortage?

Dr. Kweder:  My personal involvement is for the past year I have been the lead for our center for drugs, and for the agency on drug shortages I’ve been the person kind of at the top of the center who helps bridge all of the dozens of people in the center for drugs who are working on drug shortages. It’s not just our drug shortage program staff who is the coordinators, but people in almost every office in the center, scientific, regulatory, and enforcement, have some role in trying to address this problem.

The makers of the drugs, wouldn’t it behoove them to just make bigger and newer facilities because their profits would increase?

Dr. Kweder:  Sometimes people ask, ‘well why don’t these companies just go out and build new facilities?’ I think it’s complicated, particularly for a sterile injectable facility. I don’t know if you’ve even been in one, but they are amazing facilities; the requirements for sterility alone are incredible to see. There are people walking around in white space suits in these facilities because they can’t wear their regular clothes in to work; they have to change and shower. Every piece of equipment and plant for sterile injectables for the most part is custom made. You don’t just order them from a catalog they have to be custom made, custom designed. Even things like the air supply to the facility require special components that you don’t need in other kinds of manufacturing facilities. They take years to build and just the permitting situation alone probably takes a year to get. So they’re not easy; they’re huge investments.

What does the future look like?

Dr. Kweder:  One of the things we look at very carefully is where the most critical shortage is and they don’t seem to affect any segment of the population more than others, which is very interesting. One might think that it’s mostly elderly patients because they have more health problems, and I suppose that to some extent that is the case. However, we have had crises in shortages for pediatric cancer treatments for example. Methotrexate in 2011, that was a shortage that was transient and we were able to address that very quickly with the help of multiple companies stepping up to the plate to really address a critical problem, and it’s no longer in shortage. We see patients undergoing elective procedures in the operating room who have to have their surgeries delayed because the anesthetic agents are in short supply. Emergency rooms who have to operate differently because the usual sedatives that they use and feel most comfortable and safe are in shortage, so they have to substitute something else that requires them to completely change how they monitor patients in the emergency room. So there is no segment of our population that is untouched by this.

Tell me how many drugs right now are in shortage.

Dr. Kweder: We’re usually operating in the range of around one hundred fifty to two hundred drugs at any given time; it changes almost on a daily basis. Fortunately most shortages get resolved, which is the good news. Sometimes drugs come back in to shortage for a variety of reasons, but most shortages do get resolved. We are monitoring this continuously and we work with not just the industry but with professional organizations, including the American Society of Healthcare Systems Pharmacies. They have a web page; we have a web page, so we talk almost daily. We work with physician organizations, professional organizations, other pharmacy organizations, and we are in contact with pharmacists on the ground in this country every single day. We learn a lot from them about how what we do ultimately plays out in their community so that we can improve our communications and the way we work with companies to get information out to them.

 

For more Information on drug shortages go to the ASHP website http://www.ashp.org/shortages or the FDA website at www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

 

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