TPA Statement on FDA Approval of Gene Therapies for Sickle Cell Disease

December 11, 2023

Taxpayers Protection Alliance

For Immediate Release

Contact: Kara Zupkus, 224-456-0257

WASHINGTON, D.C. – The Food and Drug Administration (FDA) announced on December 8th the approval of two gene-based treatments for sickle cell disease. While the administration’s action to help those who suffer from that disease should be lauded, the Taxpayers Protection Alliance (TPA) wants to remind the FDA that its inaction on a COVID-19 treatment with monoclonal antibodies (mAbs) is harming health outcomes for many who suffer from that sickness.

Red tape at the FDA threatens to slow down the development of mAbs treatments for COVID. The use of mAbs is an alternative treatment for immunocompromised patients who cannot take the COVID vaccine or prescription medications due to interaction issues. It is clear that mAbs has proved effective early in the fight against COVID, but variants of the virus have sprung up quicker than FDA has approved new mAbs treatments for them. The FDA told TPA in a September letter in that it would “exercise flexibility when appropriate for a development program while ensuring that the relevant legal standards for safety and effectiveness are met.” Experts have told TPA that the FDA has approved vaccines much quicker than it has approved mAbs treatments.

TPA President David Williams offered the following statement: “The FDA needs to stop dragging its feet on approving these important treatments for immunocompromised patients who lack other options in the fight against COVID. The agency should show the same flexibility in approving mAbs as it has with vaccines against the virus so that drug producers can develop effective treatments in the long-term fight against COVID.” “The Taxpayers Protection Alliance Foundation (TPAF) sent a Freedom of Information Act Request (FOIA) asking for email communications from FDA Director Dr. Robert Califf and FDA Center for Drug Evaluation and Research Director Dr. Patrizia Cavazzoni regarding the treatment, in an attempt to uncover the truth behind their approval process.” “We are encouraged by these two gene-based treatments for sickle cell disease and we will continue working to hold these unelected government bureaucrats accountable for standing in the way of other innovative technologies and treatments that could prove fruitful even beyond COVID.”