Letter to Angus Russell, CEO, Shire Pharmaceuticals

Letter

April 28, 2011

In letter to drug manufacturer, Klobuchar urges company to properly stock supply chain to avoid future shortages

Washington, DC -- U.S. Senator Amy Klobuchar today urged Shire Pharmaceuticals, the manufacturer of a prescription drug commonly used to treat attention-deficit hyperactivity disorder (ADHD) in children, to take immediate action to address the shortage of the drug in Minnesota. The disruption in the available supply of the ADHD drug treatment, both Adderall XL and its generic version, has left Minnesota hospitals and pharmacies -- including Children's Hospitals and Clinics and Allina Community Pharmacies -- unable to fill prescriptions, forcing Minnesota patients to pay for more expensive brand-name drugs or switch to less effective treatments. Earlier this year, Klobuchar introduced the Preserving Access to Life-Saving Medications Act, which would provide the Food and Drug Administration (FDA) with key tools to help address and prevent shortages of prescription drug medications.

"To ensure that all children are safe and have every opportunity to succeed, it is vital that all forms of treatment and medication be available," Klobuchar wrote in her letter to Shire Pharmaceuticals CEO Angus Russell. "Because Shire Pharmaceuticals produces both brand and generic versions of Adderall XL, I urge you to work with the FDA, distributors, hospitals, and patients to ensure the supply chain is properly stocked."

"We're very concerned about a couple of issues that are impacting our patients," said Carrie Borchardt, MD, child psychiatrist at Children's Hospitals and Clinics of Minnesota. "There is a short supply of some of the longer-acting generic medications that we use to treat ADHD. This means children who would do best by having a medication they can take once a day in the morning do not have access to the best treatment for their needs."

Klobuchar also noted that ADHD affects approximately 5.4 million children between the ages of 4 and 7, with the rate of diagnosis increasing each year. Children with a history of ADHD are almost 10 times more likely to have difficulties that impact their peer-to-peer relationships.

The full text of the letter is below:

Dear Mr. Russell,

I am writing about a growing problem caused by the lack of availability of the generic version of Adderall XL, manufactured by Shire Pharmaceuticals, that is used to treat attention deficit hyperactivity disorder (ADHD). As you know, Minnesota is a leader in providing high-quality health care, especially when it comes to ensuring the well-being of our public health. However, due to this shortage several Minnesota hospitals and pharmacies are having difficulties filling prescriptions for these products. I urge you to take immediate action to address this shortage so that Minnesota patients, particularly children, can continue to have access to this vital medication.

Attention deficit hyperactivity disorder is the most commonly diagnosed behavioral disorder during childhood and often results in inattentiveness, over-activity, impulsivity, or a combination. It affects approximately 5.4 million children between the ages of 4 and 7 with the rate of diagnosis increasing each year. Children with a history of ADHD are almost 10 times as likely to have difficulties that impact their peer-to-peer relationships. To ensure that all children are safe and have every opportunity to succeed, it is vital that all forms of treatment and medication be available.

Due to a nationwide ADHD drug shortage, pharmacies are finding it difficult to fill prescriptions for generic version of ADHD drugs. Patients are being forced to purchase more expensive brand-name products or switch to less optimal alternatives. Because Shire Pharmaceuticals produces both brand and generic versions of Adderall XL, I urge you to work with the FDA, distributors, hospitals, and patients to ensure the supply chain is properly stocked.

While it has been reported that this shortage may be resolved in the coming weeks, I am hopeful that you can provide information to clarify what specific factors have led to this particular shortage, what actions your company has taken and is taking to address this problem, and how we can work together to prevent these disturbances from recurring.

I have introduced legislation that would include reporting requirements that will help address drug shortages, but I hope to work with the FDA, companies like Shire Pharmaceuticals, and with hospitals and consumers to develop comprehensive plans that will prevent shortages in the future.

I look forward to working with you on this important issue.

Sincerely,

Amy Klobuchar
United States Senator

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