Congressman rails at Pfizer over problems with sarin gas antidote

When Pfizer ($PFE) picked up King Pharmaceuticals three years ago, it cited the company's work with the Department of Defense as one attraction for doing the $3.6 billion deal. Now that work has landed it in hot water with a congressman because of problems with an antidote injector used by the military in case of sarin nerve gas attacks, like the recent one in Syria.

Pfizer's Meridian unit that makes the injector "has received millions of taxpayer dollars for doses of this drug, some of which do not meet specifications," Republican Rep. Andy Harris of Maryland, a physician who practiced at Johns Hopkins Hospital in Baltimore, said in a statement Monday.

Pfizer spokesman Christopher Loder told The Wall Street Journal: "We're in good faith discussions with Defense Logistics Agency to remediate and replace the affected units at Meridian's cost." In an earlier statement, Loder said, "Pfizer takes this matter very seriously and is working expeditiously to rectify this."

According to The Wall Street Journal, Pfizer made a priority of getting replacement syringes to the military after its Meridian Medical Technologies unit in March notified the FDA there were problems with the DuoDote injectors. It said about 7 out of 1,000 of the auto-injectors containing atropine and pralidoxime didn't contain enough of one or both of the drugs. The injectors also could malfunction. There is no shortage in the military, the Pentagon tells the newspaper, but some first responders such as ambulance crews that are issued the drug have run out of the injectors.

In an Aug. 27 letter, Meridian notified civilian customers that it was working on a replacement plan with the FDA for the DuoDote injectors and suggested they hold onto whatever supplies they have, even if they're past a recent expiration date. The injectors can be used for some insecticide poisoning, as well as for nerve gas. The letter details how to give additional injections if an injector fails. The company said no adverse reactions have been reported. The FDA also is taking steps to help. The injectors have a four-year shelf-life, The Wall Street Journal reports, but the agency this month extended the expiration date by one year. The two antidote drugs also can be purchased in separate doses.

Congressman Harris vented his frustration in a letter to Meridian, asking how the problem was discovered and what the company has done to make sure that doses in the Strategic National Stockpile are effective. "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," Harris wrote.

- read the Wall Street Journal story (sub. req.)
- more from The Wall Street Journal (sub. req.)
- here's the Meridian letter (PDF)
- see Congressman Harris' statement

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