In a rare opportunity for our profession, the Academy spoke directly to a congressional committee Tuesday to provide a significant patient-centered perspective of the effect of current compounding policies. Academy President-Elect George A. Williams, MD, represented ophthalmology before the U.S. House of Representatives Energy and Commerce Committee Subcommittee on Health. He expressed our belief that the government must do more to ensure the supply of compounded treatments, especially in cases of aggressive, blinding diseases.
The committee asked the Academy to testify due to our extensive leadership on the compounding and other patient-centered issues over the past decade. It is a reflection of the valued perspective we offer to federal leaders day in and day out.
Dr. Williams presented examples from ophthalmologists nationwide. He shared reports from our community of U.S. ophthalmologists of difficulties obtaining all the drugs our patients need from outsourcing facilities that supply compounded treatments. In one case, a patient was forced to drive more than 550 miles round-trip to obtain a compounded drug for treatment of acanthamoeba keratitis.
During a series of exchanges between Dr. Williams and members of the committee, he explained physicians’ frustration with current restrictions that prevent timely access to these treatments.
“I just need enough on the shelf so that when that one patient a week comes in, I can take care of her,” Dr. Williams told Rep. Morgan Griffith, R-Va. He further noted that physicians cannot obtain these office-based antibiotics through the existing outsourcing, or 503B, mechanism, which differ from 503A facilities in that they must adhere to a higher standard of manufacturing practices. The facilities may also compound for office-use without a patient-specific prescription. These standards, though, limit what these facilities regularly compound.
The hearing also included testimony from Scott Gottlieb, MD, head of the Food and Drug Administration. Representatives from dermatology, pharmacies and patient advocates also participated. We urged Congress to press the FDA to engage more directly with the Academy and other physicians’ groups. We believe this is the only certain way to ensure the FDA develops federal policies with patient care in mind.
We pushed back against FDA policies that interfere with the practice of medicine. For example, the FDA proposes to categorize Botox reconstitution as compounding. The Academy believes that FDA policy should not encroach upon minor in-office preparation activities.
In addition, we submitted written testimony to the committee that included clinical data from the Academy’s IRIS® Registry related to repackaged Avastin. The data supports our assertion that Avastin provides a safe and effective treatment. This follows recent FDA guidance that establishes a pathway to longer beyond-use dates for this and other compounded or repackaged biologics.
The Academy endorsed the FDA’s plan; however, the inclusion of new, additional testing requirements could make it difficult for facilities to keep up with demand. As a result, we believe the FDA needs to provide more details on what tests it expects.