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Drug & Device News

By ALM Staff | Law Journal Newsletters |

To Combat Drug Shortages, President Orders Changes

President Obama issued an executive order on Oct. 31 directing the FDA to take three steps to lessen the incidence of shortages of important drugs. The agency was instructed to: 1) report potential shortages of important prescription drugs; 2) speed up the review of applications to manufacture these drugs; and 3) report suspicions of collusion or price gouging concerning these drugs to the U.S. Department of Justice (DOJ). Although legislation dealing with the same concerns prompting the executive order has been pending in Congress since early this year, little has been done with the proposed measures. At the same time, a record number of drug shortages have been reported this year, with patients being required to try less effective drugs because the recommended ones simply are not available. Some of the blame for these shortages goes to supply disruptions that occur after safety issues arise at manufacturing plants, shutting down production until satisfactory changes can be made. Other shortages may be caused by ingredient supply-line problems

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