The U.S. government and Operation Warp Speed should be commended for their tireless efforts to protect Americans from the COVID-19 pandemic. At the same time, we must also ensure continued treatment access for patients who are managing eye diseases and other complex conditions.
Government-mandated COVID-19 vaccine production orders related to Operation Warp Speed have dramatically restricted manufacturers’ ability to produce other critical treatments, including the only FDA-approved treatment for thyroid eye disease.
For many patients, completing the recommended treatment program is essential to preventing the progression of diseases and conditions. Specifically, for those with Thyroid Eye Disease, patients are prescribed a 24-week course of therapy to help save their vision. Because of production of COVID-19 vaccines, the production of Teprotumumab (TEPEZZA), the only approved treatment for Thyroid Eye Disease (TED), has been suspended.
This is just one example of drug shortages that could impact patients during the pandemic. For patients with eye diseases and other complex conditions, any lapse in treatment can have negative health, emotional, and financial consequences.
The “Coronavirus Aid, Relief, and Economic Security Act,” known as the “CARES Act,” provides FDA with new authorities to address potential drug shortages without impacting the rollout of COVID-19 vaccines.
It is critical that patient advocates call on FDA to act in its authority to prevent drug shortages.