Drug Used Against Sarin Gas Exposure Has Manufacturing Issues

WASHINGTON, D.C. – The main drug used to counteract sarin gas like what was used recently in Syria has manufacturing issues according to a Wall Street Journal story Sarin Antidote Is Hit With Supply Problems in U.S. published over the weekend. The drug in question, DuoDote, is used by the United States Armed Forces, emergency personnel, and placed by the Centers for Disease Control in the Strategic National Stockpile in the event that the gas is released in the United States. Meridian Medical Technologies, the manufacturer of the drug, sent a letter to wholesalers and health professionals on August 27, 2013 to notify them of problems with the drug’s manufacturing despite having learned of the issue in early Spring. Meridian has received millions of tax payer dollars for doses of this drug, some of which do not meet specifications.  

On Thursday, September 12, Congressman Harris sent a letter to Meridian Medical Technologies.  The letter (full text below) asks the following:

  • How was the problem discovered?
  • What caused DuoDote to be out of specification?
  • What corrective actions has Meridian taken to ensure future doses are within specifications?
  • What actions has Meridian taken to ensure that doses in the Strategic National Stockpile are effective?
  • Will the government be charged for DuoDote that needs to be replaced?

“With the recent sarin gas use in Syria, the manufacturing issues surrounding DuoDote put our national security preparedness in question," said Congressman Harris.  "I am going to continue asking questions of the company and government agencies so we can all have confidence in our national defenses. Recent actions in Syria show that chemical and biological defenses can no longer be on the back burner."

 

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September 12, 2013

Tom Handel

Meridian Medical Technologies

6350 Stevens Forest Road, Suite 301

Columbia, MD 21046

Mr. Handel:

I write to inquire about issues in the manufacturing of the important drug DuoDote produced by your company.  In an August 27, 2013 letter to wholesalers and health professionals, you stated “that based on a review of product lots at its manufacturing site, Meridian personnel determined that a small number of DuoDote Auto-Injectors are out of specification. This could potentially prevent some of the units from activating or cause the patient to receive less of the drug than intended.”

Because DuoDote is used by the military to protect our service members, placed in the Strategic National Stockpile for our national defense against an attack, and used by first responders across the country, these issues are of serious concern.  With the recent use of the chemical weapon Sarin in Syria, the importance of having effective dosages of DuoDote available is of even greater importance.

Because taxpayer dollars were used for the purchase of DuoDote that could prove ineffective, I would like answers to the following questions:

  • How was the problem discovered?
  • What caused DuoDote to be out of specification?
  • What corrective actions has Meridian taken to ensure future doses are within specifications?
  • What actions has Meridian taken to ensure that doses in the Strategic National Stockpile are effective?
  • Will the government be charged for DuoDote that needs to be replaced?

I appreciate your consideration of these questions.

Sincerely,

Congressman Andy Harris

 

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