Lawmaker Wants Answers About Warning Lag on Sarin Antidote Defects

Diane Barnes, Global Security Newswire
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Diane Barnes, Global Security Newswire
Oct. 2, 2013, 3:02 a.m.

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.

The law­maker — an an­es­thesi­olo­gist by train­ing — re­spon­ded by grilling Pf­izer in a let­ter last month on sev­er­al mat­ters tied to the prob­lem 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.

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