The American Academy of Ophthalmology on Tuesday testified before Congress that more must be done to ensure the supply of compounded treatments. The Academy believes that shortages of these drugs are preventing patients from receiving immediate treatment for aggressive, blinding infections, according to an AAO news release. Ophthalmologist George A. Williams, MD, a retina specialist and health policy expert, expressed physicians' frustration with restrictions on critical, sight-saving compounded medications due to increased regulation.
The nation's leading association of ophthalmologists — physicians who specialize in medical and surgical eye care — is urging members of the U.S. House of Representatives Energy and Commerce Subcommittee on Health to press for more direct engagement between the Food and Drug Administration and physicians. The absence of this engagement is resulting in the development of federal policies that lack the vital perspectives of patients and those who provide their care.
Dr. Williams presented examples from ophthalmologists nationwide who report difficulties obtaining all the drugs they need from outsourcing facilities that supply compounded treatments. In one case, a patient was forced to drive more than 550 miles round-trip for 3 months of treatment for radial perineuritis of her cornea, a severely painful infection caused by contact-lens use.
"The Academy's community of ophthalmologists do believe that regulatory policy in this arena can become restrictive and in turn negatively impacts a physician's ability to properly and effectively treat our patients," Dr. Williams said. "Ophthalmology adamantly believes that compounded drugs must be produced safely and be subject to critically important testing."
The Academy expressed unease with a proposal floated by the FDA affecting Botox. Should the agency categorize in-office botulinum toxin reconstitution as compounding, it would interfere with the normal practice of medicine. This not only would significantly affect ophthalmologists who perform cosmetic surgery, it would also establish a precedent where minor physician-preparation activities force unnecessary costs on all medical providers.
The Academy raised a third issue related to beyond-use dates for compounded drugs. Recent FDA guidance establishes a pathway to longer beyond-use dates for compounded or repackaged biologics. The Academy endorses this plan. However, the inclusion of new, additional testing requirements could make it difficult for facilities to keep up with demand. The Academy believes the FDA needs to provide more details on what tests are expected.
Additional written testimony by Dr. Williams included clinical data from the Academy's IRIS Registry that establishes repackaged Avastin (bevacizumab), a popular compounded treatment for wet age-related macular degeneration, is a safe and effective treatment.