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You may have heard that regulators in the U.S. are too strict when it comes to stem-cell treatments. The Food and Drug Administration (FDA), this narrative asserts, is holding back effective therapies and, in the words of the most extreme, killing people by blocking their access to cures.
This is false. The claim that regulation is too harsh wrongly implies that the FDA is holding back therapies that work.
The FDA is right to insist that only proper clinical trials can make that case. And the agency’s critics are right to point out that this process is lengthy and expensive. The REGROW Act grants “conditional approval” to treatments with minimal safety data and little attention to efficacy. Most likely, there will be a flood of safe but ineffective treatments.
The FDA should strive to keep this debate on the proper topic — how to create a more efficient system that still scientifically evaluates whether treatments are safe and efficacious. To fall short would be a setback for science, and for patients.
Read full, original post: FDA should stand firm on stem-cell treatments