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# GPhA Urges Senate Action on Restricted Distribution
- URL: https://www.fdaweb.com/gpha-urges-senate-action-on-restricted-distribution/
- Published: 2016-03-18T12:00:00.000Z
- Updated: 2026-09-15T02:45:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135127

> The Generic Pharmaceutical Association (GPhA) has [urged the Senate](http://www.gphaonline.org/gpha-media/press/gpha-urges-senate-to-stop-abuse-of-restricted-distribution-agreements?ref=fdaweb.com) to put an end to restricted distribution agreements that delay generic drug competition. The group’s call to end such practices comes as the Senate Aging Committee discusses anti-competitive business practices used by brand manufacturers to stifle generic competition.  
>  
> “FDA-mandated REMS programs can, and do, serve a compelling public good,” GPhA says. “However the misuse of restricted distribution agreements, intended to deny generic and biosimilar manufacturers’ access to product samples needed to conduct bioequivalence studies that are required for FDA approval, only serves to extend market monopolies at the expense of patients.”  
>  
> GPhA says it supports the following:  
>  
> • Ensure a fully-resourced FDA can address the backlog of more than 3,400 generic drug applications stalled while waiting for approval and shorten FDA median generic drug approval timelines, which, at the industry’s best estimate, currently stand at 48 months.  
>  
> • Increase generic utilization among the low-income Medicare population, which could save up to $17.7 billion over 10 years.  
>  
> • Pass the bipartisan FAST Generics Act to curb some brand drug company abuses of FDA safety programs such as REMS used to keep generics off the market, an estimated savings of $2.4 billion over 10 years.  
>  
> • Work closely with industry and regulatory partners to ensure that the framework for biosimilars, safe and effective alternatives to costly brand biologic drugs, expands and expedites patient access.