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Generic Savings: REMS Obstruction, Not ANDA Backlog, Is Main Hindrance, AAM Says

 
• By Michael Cipriano

Association for Accessible Medicines report highlights continuing upward trend of cost savings from generic drugs; trade group argues legislative proposals addressing restricted distribution misuse are key to accelerating savings.

Dollar sign made with drug pills

Although the generic drug application backlog at the US FDA has gotten attention as an issue throughout the drug pricing debate, the Association for Accessible Medicines (AAM) says the main problem in causing further bottled up savings from generic drugs is innovators blocking access to samples.

"The reality is if our members can't get access to samples to do the necessary pharmacovigilance, it doesn’t matter whether there is a backlog or not," AAM President and CEO Chip Davis said on a June 12 conference call following the release of the association's annual generic drug cost savings report

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