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FTC issues advisory opinion approving drug shortage initiative

14 August 2012

Antitrust, Competition and Economic Regulation Alert

On 8 August 2012, the Federal Trade Commission (FTC) issued an advisory letter concluding that an initiative proposed by the Generic Pharmaceutical Association (GPhA) to address drug shortages is unlikely to harm competition. The advisory opinion responds to GPhA’s request for review of its proposed Accelerated Recovery Initiative (ARI), pursuant to which generic manufacturers of drugs in short supply will compile and provide to the U.S. Food and Drug Administration (FDA) competitively sensitive information to help FDA address drug shortages. The FTC concluded that the program contains sufficient safeguards to ensure that the sharing of competitively sensitive information that could raise antitrust concerns does not occur.

Read: "FTC issues advisory opinion approving drug shortage initiative"


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