I rise to talk about the drug shortage crisis that's spread across the country, and I'm proud to stand with my friend and colleague, Senator Susan Collins from Maine, who has been a leader on this issue and shares my concern for so many patients who are struggling to get much-needed medications.
This is a crisis that has grown to such proportions that current drug shortages have impacted individuals all across the country, forcing some patients to delay their life-saving treatment or use unproven, less effective alternatives. In some cases, drug shortages have even resulted in patient deaths. Enough is enough. We can no longer simply talk about this issue and have meetings. We need to act.
Here's one story:
A few months ago, I met a young boy named Axel Zirbies, who has a big smile and also happens to have no hair on his head because he has childhood leukemia.
Last year, his parents had just found out he had leukemia. They learned an essential drug was in short supply and might not be available for their son.
Understandably, they were thrown into a panic, desperately looking for any available alternatives. They even prepared and made plans to take Axel to Canada, where the drug was still readily available. Fortunately, it didn't come to that.
But Axel and his parents are not alone.
Earlier this month, I held a forum in Edina, Minnesota, where a woman named Mary McHugh Morrison shared her story of how she struggled with the shortage of the chemotherapy drug – Doxil.
When Doxil went into shortage last year, Mary went into chemotherapy, and she was shocked when her doctor told her they had run out of the necessary drug in the middle of the treatment.
While trying to get herself off a wait list, Mary was able to call other clinics in search of available Doxil and was able to find extra treatments four separate times. She grappled with the ethics of the fact that she was taking this limited drug out of supply for herself and not for other patients. However, because of a few delays in the treatment, Mary's doctor told her that her tumor had unfortunately returned and that she was no longer responding to Doxil.
She is going without treatment and, depending on her health condition, could be placed on a clinical trial in March.
These shortages aren't just affecting cancer patients. There are also shortages in drugs that help people improve their quality of life. This week, the Indianapolis Star Tribune reported hundreds of patients in the Minnesota Sleep Disorders Center at Hennepin County Medical Center faced shortages of Ritalin.
Risking their professional careers to adjust to their diseases and spending extra hours and days of time trying to find ways to fill a prescription… or their patient or their pharmacist doing that… or their doctors doing that or their nurses doing that…. We know how difficult this health care system is anyway, and now we are putting patients in this position and wasting the time of medical professionals to find drugs that should be readily available?
These are just a few examples of real people who are just trying to deal with their disease. And there are many, many more like them across the country. Hospitals, physicians, pharmacists are confronting unprecedented shortages. Many of these are generic drug products that have been widely used for years and are proven effective. Many of them are for cancer. The number of drug shortages has more than tripled over the last six years.
You don't just believe my stories, listen to this: Jumping from 61 drug products that were in shortage in 2005 to more than 200 last year. That's not 200 instances, Mr. President. That's 200 different kinds of drugs that affect thousands and thousands and hundreds of thousands and millions of patients across this country.
A survey by the American Hospital Association found that virtually every single hospital in the United States of America has experienced shortages of critical drugs in the past six months. More than 80 percent reported delays in patient treatment due to a shortage. This isn't just a few stories that come into our office anymore. These are the facts.
For some of these drugs, no substitutes are available. Or if they are, they may be less effective and may involve greater risks of adverse side effects. The chance of medical errors also rises as providers are forced to use second- or third-tier drugs that they're less familiar with.
A survey conducted by the American Hospital Association showed that 100 percent of their hospitals experience a shortage. Another survey conducted by Premier Health System showed that 89 percent of its hospitals and pharmacists experience shortages that may have caused a medication safety issue or error in patient care.
It is clear that there are a large number of overlapping factors that are resulting in unprecedented shortages. Experts cite a number of factors that are responsible. These include market consolidation, poor business incentives, manufacturing problems, reduction delays, unexpected increases in demand for a drug, inability to procure raw materials, and even – and this is a new phenomenon -- the influence of a “gray market,” where middlemen are hoarding the drugs because they heard there's going to be a shortage.
Financial decisions in the pharmaceutical industry are also a major factor. Many of these medications are in short supply because companies have simply stopped production. They decided it wasn't profitable enough to keep producing them. Mergers in the drug industry narrowed the focus of product lines. As a result, some products are discontinued or production is moved to different sites leading to delays.
When drugs are made by only a few companies, a decision by any one drug maker can have a large impact. To help correct a poor market environment or to prevent gray market drugs from contaminating our medication supply chain, we must address the drug shortage problem, Mr. President, at its root.
Last year, I introduced the Preserving Access to Lifesaving Medications Act to address this issue. With the support and leadership of Senator Collins and Senator Bob Casey and others, this bipartisan bill would require drug manufacturers to provide early notification to the FDA whenever there is a factor that may lead to a shortage. This will help the FDA to take the lead in working with pharmacy groups, drug manufacturers, and health care providers to better manage and prepare for impending shortages, more effectively manage those shortages when they occur and minimize -- and that's what we want to do -- minimize the impact on patient care.
The legislation would also direct the FDA to provide up-to-date public information of a shortage situation and the actions the agency would take to address them.
Additionally, the bill requires the FDA to develop an evidence-based list of drugs vulnerable to shortages and to work with the manufacturers to come with a continuity of operations plan to address potential problems that may result in a shortage.
And the bill would also direct the FDA to establish an expedited re-inspection process for manufacturers of a product in shortage.
With manufacturers providing early notification, the FDA's Drug Shortage Team -- and they do now have a Drug Shortage Team -- can then appropriately use their tools to prevent shortages from happening. In the last two years -- listen to this, if you think this wouldn't work -- in the last two years the FDA, with more information, has successfully prevented nearly 200 drug shortages.
So it does work when they get the information. But nothing requires them to get the information, and that's what we're trying to do here today. It is not the end all, be all solution for the long term, but at least in the short term when these patients are experiencing these drug shortages that can impact their treatment, that can impact their lives, it gives the FDA that extra tool to look for alternative drugs.
If they can't find them in this country, maybe they can find them in Canada. But it puts the patient first, not the drug companies.
At the urging of the bipartisan work group that I’ve been involved in, the FDA has held a public workshop last September that brought together patient advocates, industry consumer groups, health care professionals, and researchers to discuss the causes and the impact of drug shortages and possible strategies for preventing or mitigating future shortages. In addition to the workshop, we have been speaking with a broad range of stakeholders to try to discover why we have seen such a large number of shortages over the past few years.
This current explosion of shortages appears to be a consequence of a lack of supply of certain products to keep up with the substantial expansion in the scope and demand for these products. We must ensure that we have the manufacturing capabilities to keep up with the demand.
There are a lot of ideas for incentives and pricing, but we also know that those will take a long time to take effect on the immediate shortage problem. And that is why we want to get this bill passed and passed very soon.
The President has issued an Executive Order which is helpful, but it still doesn't get at the very serious problem of the kind of drug shortages we're seeing. The executive order pushes drug companies to notify the FDA of impending shortages, expands the FDA's current efforts, instructs the FDA to work with the department of justice, but there is still much more work to be done. Patients like Axel or Mary shouldn't have to be burdened with the added stress or worry about whether or not they have enough medicine. It is time for action. I urge my colleagues to pass our bill.