Letter to Margaret Hamburg, Commissioner of the Food and Drug Administration - Looming Shortage of Doxycycline, Used to Treat Lyme Disease

Letter

Dear Commissioner Hamburg,

I write today to bring to your attention a potentially life-threatening drug shortage impacting a least a thousand New Yorkers who are suffering with Lyme disease. I urge the agency to investigate this potential drug shortage of doxycycline, one of the only medications available to treat Lyme disease. It is crucial that the Food and Drug Administration (FDA) take responsibility for the public health of U.S. citizens by effectively and efficiently managing drug shortages across the country.

As you know, doxycycline is a prescription antibiotic used to treat several different types of infections such as pneumonia, respiratory tract infections and Lyme disease by preventing the growth and spread of bacteria. The Centers for Disease Control and Prevention (CDC) report an estimated 1,972 cases in New York already this year, surpassing New York's total number of Lyme cases in 2013. Furthermore, CDC estimates that there could be as many as 300,000 cases of Lyme in the United States. When Lyme disease is not caught and treated early it can cause severe fever, headache, joint pain and stiffness or, even worse, heart palpitations and swollen lymph nodes. Living with Lyme disease is painful and can be a life-long battle. This is why it is absolutely critical that the proper medications be readily available to patients.

In 2012, I strongly supported the Food and Drug Administration Safety Innovation Act (FDASIA) provisions which gave the FDA greater authority to mitigate drug shortages by requiring all drug manufacturers to provide early notification of supply and manufacturing chain disruptions. FDASIA also required FDA to issue and make available to the public noncompliance letters to manufacturers that do not properly or adequately report drug shortages. While FDASIA has prevented many drug shortages, I am concerned that more could be done to protect patients and want to work with you to alleviate all shortages. To that end, I ask that your staff provide mine with a comprehensive assessment of the doxycycline shortage and steps to ameliorate the current situation.

In addition to the provisions in FDASIA, the FDA proposed the "Permanent Discontinuance or Interruption in Manufacturing of Certain Drug and Biological Products," rule in November 2013 and I am informed that it is set to be finalized in January 2015. While there are a number of important improvements in the rule, I hope that you will work with manufacturers and patients to expand your agency's role on drug shortages. For example, the FDA could be allowed to proactively engage manufacturers in the prevention of drug shortages, which would ultimately have a more significant impact on the citizens that rely on drugs that can be used to prevent and treat debilitating diseases.

Lyme disease is only one example of an illness that when left untreated can have serious and life-threatening consequences. The current potential shortage in doxycycline could potentially harm this growing population of patients with Lyme. I urge you to take immediate action to ensure that the FDA's handling of drug shortage cases is functioning at its most efficient level.

I appreciate your consideration of this important matter, and please feel free to contact me should you have any questions.

Sincerely,

Charles E. Schumer
U.S. Senator

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