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“I think our findings raise serious concern regarding the role of manufacturers and the FDA,” Alexander says. They also suggest that far more documents currently unavailable for public and academic scrutiny might contain even more key information about the state of the opioid crisis—that’s if we can get them.
“These documents provide just a tiny peek through one window that reveals just one piece of the epidemic,” says Alexander. “There’s an enormous amount about the inner workings of the FDA and pharmaceutical manufacturers that the public hasn’t been able to see.”
Statement - Popular - Science - FDA - Spokesperson
In a statement emailed to Popular Science, an FDA spokesperson said that “the FDA shares the concerns about how [TIRF] products are being used and whether the [strategy] is working as intended.” Following suggestions made at a public advisory committee meeting in August of 2018, the spokesperson said, modifications will likely be made to the TERF REMS program.
The CDC estimates that 130 Americans die each day from opioid overdose, while the Substance Abuse and Mental Health Services Administration reports that millions of Americans misused prescription opioids in 2017. But there’s a lot we don’t know about how the FDA...
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