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Saturday, April 13, 2024 | Back issues
Courthouse News Service Courthouse News Service

Step Taken to Lessen Impact of Drug Shortages

WASHINGTON (CN) - President Barack Obama has ordered that the Food and Drug Administration help lessen the impact of prescription drug shortages.

Obama ordered that the FDA "require drug manufacturers to provide adequate advance notice of manufacturing discontinuances that could lead to shortages of drugs that are life supporting or life sustaining, or that prevent debilitating disease." This notice "can help hospitals, doctors, and patients make alternative arrangements before a shortage becomes a crisis," according to the order.

Obama also said that "an important factor in many of the recent shortages appears to be an increase in demand that exceeds current manufacturing capacity."

So, the president ordered the FDA to "take steps to expand its current efforts to expedite its regulatory reviews, including reviews of new drug suppliers, manufacturing sites, and manufacturing changes, whenever it determines that expedited review would help to avoid or mitigate existing or potential drug shortages."

Obama also ordered the FDA to "communicate to the Department of Justice (DOJ) any findings that shortages have led market participants to stockpile the affected drugs or sell them at exorbitant prices. The DOJ will then determine whether these activities are consistent with applicable law. Based on its determination, DOJ, in coordination with other state and federal regulatory agencies as appropriate, should undertake whatever enforcement actions, if any, it deems appropriate."

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