WASHINGTON — A U.S. lawmaker said a sarin-antidote manufacturer needs to explain why it took over five months longer to inform civilian first responders than Defense Department officials about defective syringes used to administer the nerve-agent treatment.
A thorough understanding of the drug company’s lag in issuing the warnings to the different customers is crucial to preventing any similar notification delays in the future about drug defects, Representative Andrew Harris (R-Md.) told Global Security Newswire.
The company, a Pfizer subsidiary named Meridian Medical Technologies, notified civilian-emergency personnel and wholesale suppliers around the United States of the problematic “DuoDote” syringes on Aug. 27, six days after a widely publicized sarin-gas strike in Syria’s civil war.
The Pentagon, though, had already been notified five months earlier about defects in similar syringes that it bought from the company to treat troops exposed to sarin.
The Food and Drug Administration audited Meridian’s manufacturing plant earlier in March, and Pfizer subsequently suspended DuoDote production to institute new quality controls at the facility, according to Harris’ office.
Harris said a Wall Street Journal reporter informed him months later about the problems, which impacted less than 1 percent of the civilian and military “autoinjector” syringes.
“Meridian has thoroughly answered all questions but one: Why did it take almost six months for the company to notify first responders of the problem?” Harris told Global Security Newswire last week. “That is a question we must answer to make sure the delay does not happen again.”
When queried directly about the delay in alerting civilian first responders about the defective syringes, Pfizer said it needed time “to investigate the issue and implement corrective action.”
The company also stressed Washington has played a role in responding to defects in the civilian syringes.
“Meridian, working in coordination with the [Food and Drug Administration], and other federal agencies needed to fully understand the implications of the problem,” company spokesman Christopher Loder told GSN in a statement.
The Pfizer subsidiary, he said, “notified [civilian] customers once FDA-approved instructions and guidance could be provided that would support the safe use of the product.
The Food and Drug Administration, though, said Pfizer made the decision about when to notify civilian holders of DuoDote about the problems, according to the congressman’s office.
The later timing of the notice to nonmilitary groups might have contributed to questions among some emergency personnel about the availability of antidote for civilian victims of a potential sarin strike.
After Meridian alerted first responders and others outside the Pentagon to the syringe defects, FDA officials advised them to hold on to certain DuoDote stocks for one year longer than their labeled expiration dates. The nerve-agent antidote should retain its potency for the extra time if stored as directed, the agency said in a Sept. 5 letter to medical personnel and bulk retailers.
The FDA move appeared to be an attempt to compensate for the suspension in DuoDote production. However, some emergency responders indicated they had already thrown away DuoDote that had aged out of its original four-year use period. A Sept. 13 Journal article notes that Tennessee authorities pulled lapsed doses of the drug from ambulances before the shelf-life extension in late summer.
Back in Washington, Harris as of press time had yet to learn how Pfizer’s subsidiary plans to deal with defective syringes held by civilian first responders.
However, Loder said Pfizer plans to “replace or remediate” affected military antidote syringes that are still “within expiry,” and added that “Meridian expects to reach the same agreement with [civilian] purchasers of DuoDote.”
Harris told GSN last week that he planned to keep tabs on how the firm acts on its pledge to quality-check the more than 2 million sarin-antidote doses stocked by the Defense Department.
“I believe this problem will be resolved, and hopefully it will be resolved without anyone ever having to use the deficient dosage units before they get replaced,” the congressman said.
Meridian has already subjected 1.1 million military antidote syringes to physical inspection and discarded any that lacked sufficient antidote, an unnamed military official said in an article by the Pentagon‘s American Forces Press Service.
The United States in 2010 and 2012 awarded Meridian more than $250 million in nerve-gas-antidote contracts for the military alone, the Journal reported. The Obama administration last week announced a new $60 million deal for Meridian to study how an existing sedative could treat seizures from nerve-agent exposure.