S-10 Symposium: Current Hot FDA Topics: Update on Drug Compounding and 21st Century Cures Initiative
Sponsored by the ASCRS FDA Committee
Moderator: Natalie A. Afshari, MD, FACS*
This Symposium will be comprised of two panels: Drug Compounding and its Impact on Ophthalmology and the 21st Century Cures Initiative.
Drug Compounding and its Impact on Ophthalmology: This portion of the symposium will focus on the key issues impacting ophthalmology relating to the recent enactment of the Drug Quality and Security Act, such as office use of compounded drugs and continued access to repackaged drugs. The recent FDA guidance released on 503A facilities (traditional compounders) requiring patient specific prescriptions regardless of state law, is causing access issues for many ophthalmic practices. In addition, to date, FDA has yet to provide guidance on the ability of the newly formed Outsourcing Facilities to repackage drugs. These Outsourcing Facilities are compounding facilities that have agreed to comply with the more rigorous 503B requirements including being inspected periodically by the FDA, reporting adverse events and complying with current good manufacturing practices. Panelists will review the impact these new regulations have had and will have on ophthalmic practices.
Panelists: Charles Leiter, PharmD
CEO and President, Leiter’s Compounding Pharmacy
Mark L. Baum
CEO, Imprimis Pharmaceuticals, Inc.
21st Century Cures Initiative: This panel will discuss the current 21st Century Cures Initiative led by the US House of Representatives Energy and Commerce Committee with a focus on the expedited approval of drugs and devices in the United States. The 21st Century Cures Initiative is investigating what steps can be taken to accelerate the pace of cures and medical breakthroughs in America, including reviewing biomedical research, streamlining the drug and device development process and using social media during the treatment and delivery phase of healthcare. Panelists from the FDA will address what FDA has been doing and what they are planning to do in the future to make the drug and device approval process more efficient.
Panelists: Wiley A. Chambers II, MD
Deputy Director of the Division of Transplant and Ophthalmology Products, Center for Drug Evaluation and Research, Food and Drug Administration
Malvina B. Eydelman, MD
Director, Division of Ophthalmic and Ear, Nose & Throat Devices, Food and Drug Administration