Advocacy & Practice Updates — Advocacy & Practice

ASRS Attends FDA Public Forum on Pharmacy Compounding

July 9, 2014    --    Back to Retina Practice News

On June 26, the FDA held a public forum, meeting with several physician groups on pharmacy compounding.  Representing ASRS and AAO was Suber Huang, MD, MBA, ASRS immediate past president and AAO compounding task force chair and AAO chair of the research, regulatory, and external scientific affairs committee. In his remarks, Dr. Huang emphasized access to treatment, the need for patient and physician choice, and how cost is an important component of being able to provide appropriate and timely treatment of blinding disease. Dr. Huang suggested that the FDA has a unique opportunity to provide leadership and innovative, well-balanced approaches to concerns of safety and access.  

Dr. Huang indicated that the ASRS is committed to ensuring that retina specialists have access to cost-effective compounded drugs (such as Avastin) that are prepared with high quality material following good quality controls and sound engineering design by appropriately trained personnel. He also stated that while the ASRS strongly supports actions to ensure the safety and sterility of compounded products, we are concerned that actions to bolster regulation of compounding pharmacies may inadvertently preclude access to essential drugs necessary for treatment of patients with vision-threatening conditions, particularly emergency situations.

The FDA did not have a firm policy statement at this time, stating that any policy statements would be made in the form of draft guidance/proposed rules and would be released in time for public comment. The FDA is in the process of meeting with several other stakeholder groups, such as pharmacy/industry representatives, hospital groups, consumer groups and insurers in the next few weeks. The ASRS continues to be actively involved in this issue.

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