Cloture Motion

Floor Speech

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Mr. WYDEN. Mr. President, our country is facing a medication shortage crisis. Americans can no longer count on their medicines being available at the pharmacy counter when they need them.

Unfortunately, it is actually worse than a simple shortage. It is, in particular, that America doesn't have access to an adequate supply of generic drugs that can be stocked by our pharmacies.

I have heard from parents throughout my State whose kids are sick with a strep throat, and they are out there scrambling from pharmacy to pharmacy trying to track down a basic antibiotic. These concerns are especially serious in rural parts of my State--I think this is true in a lot of parts of this country--because of the long distances families have to drive if their community pharmacy in a rural area can't meet their needs. This, in my view, is an enormous and urgent national challenge.

There are, for example, cancer patients who can't get treatment because the medication they need is in low supply. With cancer, we know every single second counts. In many cases, people die if they are not treated. This makes the crisis not abstract, but it is a real life-or- death crisis. There are Americans suffering from ADHD who can't get their hands on the medications they rely on that their doctor prescribed to them to help so they can function at school, at work, and at home.

A pharmacist in southern Oregon told me that one of their patients went without their medication for almost 2 months, and it undercuts their ability to complete daily tasks. Derailing these lives--young and old--due to a generic drug shortage just has got to be unacceptable-- unacceptable--to the richest country in the world.

Now, the crisis is hurting Americans in many places; but as I have indicated, it is especially stark in rural America. Independent pharmacies have been essential in rural communities in my State. These pharmacies can't always afford to keep brand-name drugs stocked, especially during a shortage. They rely, as do so many of these pharmacies across the land, on available generic medicines so they can serve their customers and stay in business.

And the travel I mentioned from pharmacy to pharmacy to get needed medications is no simple challenge. I'm having a whole group of town halls in eastern Oregon at the end of this month. I made a commitment to have an open-to-all town meeting in every county that I have the honor to represent. I've had 1,050 of them, and I can tell you the distance between small towns in eastern Oregon is often measured in hours, not miles or minutes. So if you live in rural Oregon and your local pharmacy lacks your medication, you have got to find the time and the gas money to travel anywhere from 60 to 90 minutes to the next closest pharmacy and hope and pray that the medication hasn't just been sold before you got there. These commute times are even longer in the winter months when the weather conditions are especially serious.

I heard recently about an Oregonian who went to the pharmacy every day for 2 weeks--2 weeks--to get that day's shipment of the prescription they needed. Every single day, they went to the pharmacy. That is a lot of time spent on top of working, taking care of a family, and trying to get your basic needs met. This is going to get worse in pharmacies across Oregon and the Nation without this Congress and our country acting.

Shortages of these generics has generated a domino effect. It's caused shortages of alternative medications to treat ADHD. And so many Americans--millions and millions--have looked for this drug, and they are looking for alternatives. And some of these other medicines may be less effective. We ought to be clear, in some cases there is no domino effect because some generics don't have any alternatives at all.

I asked a pharmacist in eastern Oregon to share with me how this has affected the people she and her family serve. She told me that many customers who took medication that were working very well are now bumping up against this shortage. So now a patient's doctor, according to this pharmacist, will write a prescription for another medication and then change the patient back to the original preferred medication-- the one that has been working for them--if and when it is available. In essence, the doctors are forced to lurch as their patients go back and forth from one medicine to another--medicines that can have a different effect--if they can get them.

Another patient in rural Oregon was receiving the generic for Adderall at a 30-milligram dose, which suddenly became unavailable. Their insurance wouldn't pay for the brand-name drug, so the patient was forced to take a lower dose version of the generic. This patient has to change the medication every month, not based on their medical needs, but trying to figure out what their rural pharmacy is going to be able to provide.

Then, because ADHD medicines are Schedule II drugs, the prescriptions can't be transferred between pharmacies. If a person's medication isn't available at their local pharmacy but is available at a pharmacy 90 minutes away, patients in this situation have to double back to their doctor to get a new prescription before they can even start the trek to the distant pharmacy. So sometimes this means the patient has to physically drive to the doctor's office and pick up a hard copy of the prescription if the doctor isn't registered with the Drug Enforcement Agency, the DEA.

Just picture this kind of bureaucratic nightmare for people who are just hoping--hoping--in small towns that somebody is thinking about their needs. But the idea of physically driving to a doctor's office, getting a hard copy of the prescription when the doctor, as I said, isn't registered with the DEA to prescribe the drugs electronically is just a microcosm of what these patients in rural Oregon and rural America are telling us.

A rural pharmacist told me that what I just described happened this week with a patient who was forced to drive from Heppner to Pendleton, an hour and a half away, to pick up their physical, paper prescription, and then off they went to their pharmacy.

Now, there are a variety of reasons of why we have these shortages; but when it comes to the ADHD medication, specifically, part of the problem may be that the generic drug manufacturers are not communicating with the government Agencies who regulate the manufacturing of these drugs. And neither the generic manufacturers nor these Agencies are communicating effectively with the public, which is why so many Members of Congress are getting these calls asking them to step in and help.

Now, the DEA is in charge of how much of this ADHD medication can be produced and dispersed. Okay? This is the Agency that tells you how much of this medication is going to be available. They are telling me drug companies can make more medication any time they want to. The companies say, not so. They are saying what the DEA says isn't true. The companies claim that the DEA is denying their applications to make more medicine during the shortage. Now, add to this the Food and Drug Administration, the FDA, saying they don't know of any denials to make more drugs handed down by the Drug Enforcement Agency to the drug manufacturers and that the DEA has approved applications that the FDA has weighed in on.

So if your head is now spinning as you try to sort through the word salad, as I call it, of American healthcare, it is understandable, because at every level, there are new requirements that you try to reconcile with what I have already described.

The Secretary of Health and Human Services is required by law to post justifications when the DEA denies these kinds of applications on the FDA's website, but none have been posted. So if you are a patient who is hurting or a family who is trying to treat a sick child or an elder, you deserve something better--something better--than the chaos I have just described. Again, companies are saying their applications to make more medicine have been denied.

So I have just given you the conflict between these Agencies that, heaven forbid--quaint idea--would actually talk to each other. Something doesn't add up, so the Senate is going to have to step in and sort this out so that the citizens of this country get straight answers. And this bureaucratic doublespeak is particularly hard on Oregonians who come to me and ask why they are suffering from a crisis that is not of their making.

Now, I recently spoke to the Administrator of the Drug Enforcement Agency. She was aware I had an interest in this as I serve as chairman of the Senate Finance Committee, and she agreed that greater transparency in the process is going to help the ongoing work of the Agency to reform the system.

Well, we are sure going to hold them to that. Certainly some clear, at least coherent language is desperately needed and better communication for the patients. That is what I am insisting on from the Drug Enforcement Agency and the FDA because they have a responsibility to reach out to these companies of these essential medicines to sort these out and make these medicines accessible to the American people, and the Agencies ought to give the manufacturers clear guidance on how to navigate the bureaucratic fiefdoms that exist here in Washington.

I will also say that I am concerned that despite this heightened attention to medication shortages, these Agencies appear to be solely focused on production at the national level, and there is no real connection to the local pharmacy window. We know that when we finally took away the grail--the Holy Grail--from the pharmaceutical companies and that Medicare could negotiate to hold down, you know, prices, one of the reasons we did is that we knew this issue really mattered at the pharmacy window. That is when people in New Jersey and Oregon and everywhere else want to have available drugs and have them made affordable. It has to become local.

Further, it is important not just to focus on the production and availability of these drugs like Adderall but to ensure that the generic equivalents are broadly available and recognized as a part of access for patients. For instance, a copay for the generic medicine could be $10. If it is not available, and after the pharmacy spends 45 minutes on the phone with the patient's insurance company and the patient, the name brand Adderall could be approved, but even with insurance, the patient could face a copay of anywhere from $75 to $200.

For all of those families in America who are walking an economic tightrope in balancing their food bill against their fuel bill and their fuel bill against their rent bill, they are not going to be in a position to pay these constantly escalating prices, and, you know, when you are trying to feed your family, you might make your own health your lowest priority.

So the Federal Agencies need to help manufacturers get better at reporting spikes in consumer demand for important medicines that they are going to have a hard time meeting, and Congress has to work on making it a requirement--a requirement--for the manufacturers to report this information.

I am going to close by offering a really radical idea: that the Food and Drug Administration and the Drug Enforcement Administration get together and work this out, because it is not about Democrats and Republicans. I am a Democrat, and the Republicans sit over there. This has nothing to do with that--nothing--but it has everything to do with the proposition that Americans deserve better. These Agencies that I have cited ought to give a full explanation to the American people about what they are doing now, what they are doing a month from now, and what they are going to be doing until they get this fixed.

In my call to these two Agencies, I believe--and I know the Presiding Officer does--that Americans ought to be able to get the healthcare they need when they need it, and right now, too many Americans are suffering because they can't, particularly with respect to those who need medicines to deal with ADHD.

We are hurting people's lives. In the worst case, I believe Americans may be using drugs not prescribed by their doctors as a result of all of this bedlam I have described.

I will tell the Presiding Officer, in wrapping up, you know--and he and I have talked about this--that I was the co-director for the Oregon Gray Panthers for many years, and this has been the area of healthcare I have really tried to specialize in because I have always felt that if you and your loved ones don't have your healthcare, everything else goes by the board. I don't recall very many examples of this kind of dysfunction. I don't know any other way to sum it up. This kind of dysfunction is unacceptable to the millions of Americans who need this medicine.

So I am going to stay at it. I know the Presiding Officer well enough to know that he feels strongly about helping exactly these kinds of people. It is a problem that is hammering families from one end of the country to another. It is particularly hard right now as we speak on the folks I represent in rural Oregon, the folks I am going to see at the townhall meetings here in a few days. We are going to stay at it until we get it fixed.

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