Letter to Margaret Hamburg, Commissioner of the Food and Drug Administration

Letter

Following reports that a new, highly recommended shingles vaccine is in short supply, U.S. Senator Amy Klobuchar today sent a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg urging the agency to take steps to address the shortage. The Centers for Disease Control (CDC) recently recommended that most Americans over the age of 60 be vaccinated to prevent shingles, but the leading manufacturer of the vaccine yesterday announced that many orders won't be filled until April.

Earlier this week, Klobuchar introduced the Preserving Access to Life-Saving Medications Act with Senator Bob Casey (D-PA) that would give the FDA the ability to require early notification from pharmaceutical companies whenever a factor arises that may result in a drug shortage. The American Society of Health-System Pharmacists currently lists 150 "medically necessary" drugs that are in short supply, which is double the number from five years ago.

Shingles is a painful and potentially serious ailment that will afflicts nearly one of three people in the United States. The new vaccine, Zostavax, reduces the risk of getting shingles by 55 percent, according to the CDC, but a limited supply of the virus varicella -- which is used to make the vaccine -- is causing a shortage.

The text of the letter follows:

Dr. Margaret Hamburg

Commissioner

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

Dear Commissioner Hamburg,

I am writing about recent reports regarding the availability of certain prescription drugs and vaccines that protect individuals from unnecessary outbreaks of harmful diseases. As you know, Minnesota is a leader in providing high-quality health care, especially when it comes to ensuring the safety of our public health.

Due to a recent recommendation by the Centers for Disease Control and Prevention (CDC) suggesting all individuals above the age of 60 should be vaccinated against shingles, demand for Zostavax, a vaccine used to prevent shingles, has increased dramatically while supply has fallen short. As a result, individuals are faced with a higher risk of contracting shingles as providers struggle to find vaccines to administer.

Shingles afflicts over one million people each year, yet only 10 percent of individuals over the age of 60 were vaccinated in 2009. As the population begins to age, we must ensure that they will be protected from any potential outbreak of this disease.

I urge the Food and Drug Administration (FDA) and the CDC to work with manufacturers, providers, and other stakeholders to find an immediate solution to the shortage of Zostavax. It is essential that the FDA act expediently to ensure that patients have access to the medications that are essential to their health and well-being.

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

Sincerely,

Amy Klobuchar

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