Compounding/Preserve Access to Avastin

Compounding

In 2012, a fungal meningitis outbreak linked to tainted sterile compounded drugs from the New England Compounding Center brought about an evolution that has transformed the compounding industry.

The outbreak prompted the U.S. Food and Drug Administration (FDA) to tighten regulations on compounding pharmacies and spurred state pharmacy boards to review their compounded medication regulations. Numerous state boards of pharmacy began requiring individual patient prescription for compounded medical orders putting access to sight-saving Bevacizumab (Avastin®) in limbo for patients who rely on it for effective off-label treatment for age-related macular degeneration (AMD) and other conditions.

In 2013, the Drug Quality and Security Acts was signed into law, creating a new category of more highly-regulated compounding pharmacies known as ‘outsourcing facilities’ (or 503Bs) and giving the FDA new oversight authority for the compounding of prescription medications. As part of their enforcement of the law, the FDA is now mandating patient-specific prescription for all drugs compounded at traditional compounding pharmacies (known as 503As), further threatening patient access to compounded drugs.  

ASRS launches Take Action to Preserve Avastin

A new concern emerged with the FDA’s February 13, 2015 introduction of its ‘Draft Guidance on Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application,’ which proposes excessively short beyond-use dates (BUDs) for traditional compounders and outsourcing facilities that essentially puts bevacizumab out of reach entirely for retina specialists and their patients who rely on it for sigh-saving treatment.

In response ASRS launched ‘Take Action to Preserve Avastin,’ a grassroots campaign that generated 300 unique member letters urging the FDA to maintain availability of repackaged bevacizumab by setting aside arbitrary proposed BUDs and focusing on the science. In fact, extensive clinical research summarized in peer-reviewed literature has shown that repackaged bevacizumab remains stable, sterile, and efficacious with BUDs longer than those proposed by the FDA when standardized aseptic procedures are followed.

In June 2015 ASRS, AAO and others urged members to support both congressional and senatorial sign on letters to help increase the BUDS. As we await the final rule, ASRS continues to work with major stakeholders to help guide FDA policy to preserve access to compounded and repackaged drugs -- most notably bevacizumab. 

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