Is the FDA Withholding Data to Protect a Drug Manufacturer?


From Scientific American: The FDA seems determined to prevent the public from accessing valuable data about the safety, efficacy, and potential adverse effects of the Duchenne muscular dystrophy drug eteplirsen.

“Why would the FDA block evidence of outcome switching, sit on possible evidence of scientific misconduct, and even hide references to a medication’s side effects? The reasoning takes a bit of unpacking, but it boils down to a simple principle: FDA is refusing to release this information because it might hurt Sarepta, the maker of eteplirsen.

The FDA has stated that the redacted sections represent ‘trade secrets and commercial or financial information obtained from a person and privileged or confidential.’ In this particular case, this tends to mean that the release of the information will cause ‘substantial competitive injury’ to the company that turned it over to the FDA.”

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