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International

US Ophthalmologists lobby congress

27/03/2018
The United States Congress has been urged to lift regulatory restrictions on the supply of compounded treatments in order to enhance access to these medicines for the treatment of aggressive and blinding infections.

Ophthalmologist and health policy expert Dr George Williams made the appeal on behalf of the American Academy of Ophthalmology (AAO) and expressed physicians’ frustration with restrictions on sight-saving compounded medicines.

Increased regulation of these medicines has caused a shortage of supply and prevented patients from accessing these critical treatments.


"Ophthalmology adamantly believes that compounded drugs must be produced safely and be subject to critically important testing."
Dr George Williams, Ophthalmologist and health policy expert

“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,” Williams said.

“Ophthalmology adamantly believes that compounded drugs must be produced safely and be subject to critically important testing.”

To support his point, Williams presented examples from ophthalmologists nationwide who reported difficulties obtaining the drugs they needed from the outsourcing facilities that supply compounded treatments.

In one instance, a patient was forced to drive more than 885 kilometres just to secure three months of treatment for radial perineuritis of the cornea.

The AAO has long been advocating for the Energy and Commerce Subcommittee on Health of the US House of Representatives to push for more direct engagement between the US Food and Drug Administration (FDA) and physicians.

According to the academy, the absence of this engagement has resulted in the development of federal policies that lack vital input from patients and those who provide their care.

Williams also provided written testimony to Congress that included clinical data from the AAO’s IRIS Registry, which established bevacizumab (Avastin) was a safe and effective treatment for neovascular age-related macular degeneration.

A dose of bevacizumab is around 38x cheaper than the currently used ranibizumab (Lucentis).

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