Senators Demand Answers on FDA Guidance That Could Restrict Popular Treatment for Macular Degeneration

Collins, McCaskill: FDA guidance could cost taxpayers billions of dollars

WASHINGTON – U.S. Senators Susan Collins (R-Maine) and Claire McCaskill (D-Mo.) today requested that the Food and Drug Administration (FDA) turn over documents supporting new proposed guidance that could dramatically limit the availability of a popular and inexpensive treatment for macular degeneration.

In a letter to Secretary of Health and Human Services Secretary Sylvia Burwell, the Senators outline their concerns about new guidance regarding drugs repackaged in compounding pharmacies—and that guidance’s potential effects on the drug Avastin, which has been used off-label to treat macular degeneration for more than a decade. Avastin, which costs roughly $50 for a repackaged dose, is currently used to treat approximately 60% of patients with age-related macular degeneration, the leading cause of severe vision loss in older Americans. The two alternative treatments on the market cost roughly $2,000 per dose.  

“Limiting access to repackaged pharmaceuticals could end up costing Medicare billions over the coming decade,” the Senators wrote to Secretary Burwell.

The Senators asked the FDA to provide them with all documents considered in formulating the draft guidance, as well as which organizations, groups, and industry leaders were consulted during the drafting process.

The Special Committee on Aging promotes discussions and conducts investigations on areas of special interest to older Americans.

A copy of the Senators’ letter is available online HERE.