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FDA Spurns Innovation—and Turns Its Back on Desperate Patients

December 14, 2022
by Naomi Lopez

The COVID-19 pandemic showed Americans how accelerating innovation in medicine can save countless lives. But now, it appears the federal government has once again turned its back on rapidly approved vaccines and therapeutics—and the consequences are dire for terminally ill patients, pre-term babies and their mothers, and all who are holding out hope for potentially life-saving treatments.

Consider how a promising new treatment offered a glimmer of hope to the 30,000 Americans with amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease—only for the federal government to snatch that hope away. Last month, the U.S. Food and Drug Administration (FDA) refused to even consider whether or not to approve a stem cell therapy that’s shown promise in treating this debilitating disease, which robs patients of their mobility, ability to communicate, and ultimately their lives. The FDA issued a refusal letter to Brainstorm Cell Therapeutics’ Biologics License Application for its “NurOwn” therapy—despite recent and growing data suggesting that the treatment may have a more significant clinical result in patients with less severe disease progression.

Meanwhile, the tiny handful of ALS patients who were fortunate enough to personally benefit from the treatment are now petitioning the FDA to hold an Advisory Committee meeting to review and discuss the treatment outcomes. It’s understandable that they want to shine a light on the FDA’s decision—after all, the FDA has a long and well-documented history of obscuring the process it uses to make life-or-death decisions. But these decisions should never be government secrets in the first place.

Read the rest of the op-ed at RealClearHealth.

Naomi Lopez is the Vice President for Healthcare Policy at the Goldwater Institute.

 

 

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