Washington, DC — U.S. Senators Amy Klobuchar (D-MN) and Susan Collins (R-ME) today called for swift action to prevent critical drug shortages that are affecting families across the country. In a speech on the floor of the U.S. Senate with Senator Collins, Klobuchar highlighted the stories of Minnesota patients struggling to access essential medications for cancer, ADHD and sleep disorders, and the two senators urged their colleagues to take immediate action to pass their bipartisan legislation that would give the FDA the tools it needs to help prevent drug shortages. The bill is cosponsored by twenty-two senators, including Senator Bob Casey (D-PA).
“Patients’ energy should be focused on getting better and living healthy, productive lives - they shouldn’t be burdened with the added stress and worry of whether or not they will have enough medicine to treat their condition tomorrow,”Klobuchar said. “I urge my colleagues to take immediate action and pass our legislation that will help ensure patients have access to the vital medications they need.”
“The shortages of these vital drugs are causing serious problems around the country, including forcing some medical centers to ration drugs, postpone elective surgeries, or even modify chemotherapy regimens midcourse,”said Senator Collins. “Our legislation aims to give the FDA the tools and information they need to prevent drug shortages, and ensure that our hospitals and health professionals are able to provide the best care medical science allows- giving patients the medications they need when they need them.”
Last February, Klobuchar and Casey introduced the Preserving Access to Life-Saving Medications Act. The bill would require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage, as well as direct the FDA to provide up-to-date public notification of any actual shortage situation and the actions the agency would take to address them. The FDA prevented nearly 200 drug shortages in 2011 due to voluntary early notifications from companies, up from 38 in 2010. During a recent FDA workshop, FDA officials said that the rise in preventions is due to increased pressure from Klobuchar and other members of Congress.
In October of 2011, President Obama issued an executive order advancing the key provision in the bill, which urged pharmaceutical companies to notify the FDA of impending prescription drug shortages. Additionally, the FDA action took that order one step further by expanding requirements on certain manufacturers of lifesaving, medically necessary drugs.
Klobuchar is a member of a bipartisan drug shortages working group in the Senate, which is aimed at bringing together patients, doctors, pharmacists, manufacturers, and the FDA to stop drug shortages. Earlier this month, Klobuchar held a forum in Edina, Minnesota with Federal Trade Commission (FTC) Chairman Jon Leibowitz and Minnesota Attorney General Lori Swanson to discuss the drug shortages crisis and how to ensure patients have access to affordable medications.
The full text of Klobuchar’s prepared remarks is below.
I again rise today to talk about the drug shortage crisis that has continued to spread across the country. I am proud to stand here with my friend, Senator Susan Collins from Maine, who shares my concern for the patients struggling to find 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 treatments or use unproven, less-effective alternatives. In some cases, drug shortages have even resulted in patient deaths.
Here’s one story:
A few months ago, I met a young boy named Axel Zirbes.
Axel has bright eyes and a big smile. And he also happens to have no hair on his head.
That’s because Axel is being treated for leukemia.
When he was scheduled to start chemotherapy last year, Axel’s parents learned that an essential drug – cytarabine – was in short supply and might not be available for their son.
Understandably, they were thrown into a panic and desperately looked for any available alternatives.
They even prepared 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 where a woman by the name of 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 was in the middle of her chemotherapy regimen and was shocked when her doctor told her that they had run out of drug necessary to continue her treatment.
While trying to get herself added to a waitlist, Mary was able to call around to other hospitals and clinics in her area in search of any available Doxil and was able to find extra treatments four separate times. However, because of a few delays in treatment, Mary’s doctor told her that her tumor had unfortunately returned and that she was no longer responding to Doxil.
She is now going without treatment and depending on her health condition, could be placed on a clinical trial at Mayo Clinic in March.
But these shortages aren’t just affecting cancer patients. There are also shortages in drugs that help people improve their quality of life.
Just this week, the MinneapolisStar Tribune reported hundreds of patients in the Minnesota Sleep Disorders Center at Hennepin County Medical Center have suffered a shortage of Ritalin, Adderall and their generic equivalents.
These shortages have had significant impacts on these patients’ quality of life – often times forcing them to pay hundreds more for expensive alternatives…
Or risking their professional careers to adjust for their diseases…
And spending extra hours and days just trying to find ways to fill their prescription. A process that used to take a few minutes.
These are just a few examples of real people who are just trying to deal with their unfortunately diseases. And there are many, many more like them.
Across the country, hospitals, physicians and pharmacists are confronting unprecedented shortages of important medications, especially for cancer.
Many of these are generic drug products that have been widely used for years and are proven effective.
The number of drug shortages has more than tripled over the last six years – jumping from 61 drug products in 2005 to more than 200 in 2011.
A survey by the American Hospital Association found that virtually every hospital in the U.S. has experienced shortages of critical drugs in the past six months.
More than 80 percent reported delays in patient treatment due to the shortages.
For some of these drugs, no substitute drugs are available. Or, if they are, they’re 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 nearly 100 percent of their hospitals experienced a shortage. Another survey, conducted by Premier Health System, showed that 89 percent of its hospitals and pharmacists experienced 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 for the shortages. These include market consolidation and poor business incentives, manufacturing problems and production delays, unexpected increases in demand for a drug, inability to procure raw materials, and even the influence of the “gray market”.
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 have 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 drugmaker 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 at its root.
Last year, I introduced the Preserving Access to Life-Saving Medications Act to address this issue. With the support of Seantor Collins and Senator Bob Casey and others, this bipartisan bill would require drug manufactures to provide early notification to the FDA whenever there is a factor that may lead to a shortage.
This will help FDA take the lead in working with pharmacy groups, drug manufacturers and health care providers to better prepare for impending shortages, more effectively manage shortages when they occur, and minimize their impact on patient care.
The legislation would also direct the FDA to provide up-to-date public notification of any actual 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 up 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 reinspection process for manufacturers of a product in shortage.
With manufacturers providing early notification, the FDA’s Drug Shortage Team can then appropriately use their tools to prevent shortages from happening. In the last two years, the FDA, with early notification and more information, has successfully prevented nearly 200 drug shortages.
I understand that this may be a short-term solution to a long-term problem. That’s why I have been working with several of my colleagues in the Senate to come up with a broad, permanent solution – one that includes methods to address the root causes of drug shortages.
At the urging of this bipartisan working group, the FDA held a public workshop last September that brought together patient advocates, industry, consumer groups, health care professionals, and researchers to discuss the causes and impact of drug shortages and possible strategies for preventing or mitigating future shortages.
In addition to the workshop, I 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 a substantial expansion in the scope and demand for those products.
Due to the complex nature of these drug shortages, there is no single or simple solution that will solve all problems. A solution will require all stakeholders to play a role in mitigating future drug shortages.
We must ensure that we have the manufacturing capabilities to keep up with demand. One solution may be to provide tax incentives to incentivize manufacturers to continue to make drugs that are on the shortage list. Or to provide other market incentives, such as including exclusivity pricing, similar to those we give to manufacturers who make orphan drugs.
In addition, I have urged FDA to improve their communication with patients and providers. This will ensure that patients and doctors are not the last to know when there is a shortage.
But one thing is clear: This is a national public health crisis that must be addressed.
This past October, the President issued an Executive Order that:
- Pushes drug companies to notify the FDA of any impending shortage of certain prescription drugs,
- Expands FDA’s current efforts to expedite review of new manufacturing sites, drug suppliers, and manufacturing changes, and
- Instructs the FDA to work with the Department of Justice to examine whether drug companies have responded to potential drug shortages by illegally hoarding medications or raising prices to gouge consumers.
The FDA has also issued an Interim Final Rule that expands the requirement of sole-source manufacturers to provide early notification to the FDA so the agency can work with manufacturers, hospitals, pharmacists, and patients to find ways to prevent drug shortages.
These actions will provide additional tools to address drug shortages, but legislation is still needed to protect patients and ensure consumers have access to the life-saving medications that they need and deserve.
I will continue to work with my colleagues in the bipartisan working group to try to develop a broad and permanent solution and urge my colleagues to support this legislation that will help ensure access of needed medications for our nation’s patients.
Patients such as Axel or Mary shouldn’t have to be burdened with the added stress and worry about whether or not they will have enough medicine to treat their disease tomorrow. Their attention and energy should be focused on getting better and living healthy, productive lives.
As awareness of this issue has spread across the country, more and more Senators have been hearing from their constituents who are struggling to find much needed medications.
Just as I learned of this issue from patients back home, my friend from Maine, Senator Susan Collins—who is a cosponsor of this bill—has also been hearing stories from her constituents about shortages in life-saving medications and delays in treatment.
I appreciate her hard work on this issue and concern for her patients…and I look forward to working with her and my other colleagues in finding a solution to prevent a shortage from being the reason why a patient cannot win their battle against their disease.
But I will say to my colleagues, the time for talk and discussion is nearing an end. It is time to do something.