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Former FDA Associate Commissioner Peter Pitts said Thursday that while formula manufacturer Abbott is responsible for nationwide shortages by failing to safely maintain their factory, the FDA can have better protocols to handle major production shutdowns.
“That plant needed to be shut down,” Pitts said on “Fox & Friends.” “The FDA has been 24-7 on-site since February with Abbott to get this plant back online.”
“What the FDA didn’t do was say to parents, ‘There might be some spot shortages here. Be aware of that. Be prepared. Stock up,’” he said. “They waited for parents to go to the market and all of a sudden the shelves are empty… that was a mistake.”
The Michigan manufacturing plant will be allowed to release products again as the nationwide formula shortage reaches “crisis” levels. The shortage, however, could last another 10 weeks.
Pitts explained to co-host Ainsley Earhardt there is no strategy in place for instances when a major manufacturer in a consolidated industry is shut down due to safety, mother nature or a terrorist attack.
The Abbott plant was forced to shut down in February after the U.S. Food and Drug Administration found a failure to follow safety protocols and water on the floor.
FILE – Abbott Laboratories manufacturing plant is shown in Sturgis, Mich., Sept. 23, 2010. (Brandon Watson/Sturgis Journal via AP, File) (AP)
Pitts said the way to prevent this type of crisis is to provide more funding for the FDA to conduct regular robust inspections of factories so that they don’t get “lax,” like the Abbott plant.
“Also, the FDA needs to be empowered to plan for drug shortages in these industries that are consolidated on the food side and on the drug side,” he said.
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He then called on Congress to “name and shame” Abbott for not maintaining a safe facility.
These steps, Pitts said, will “restore faith in the eyes of the American public.”
