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by sammalloy 1217 days ago
"How FDA Failures Contributed to the Opioid Crisis" https://journalofethics.ama-assn.org/article/how-fda-failure...

1. Failure to Properly Enforce Marketing Regulations

2. Failure to Obtain Evidence of Long-term Safety and Effectiveness

3. Failure to Manage Conflicts of Interest

And my personal favorite:

> An FDA official who led the approval of OxyContin got a $400,000 gig at Purdue Pharma a year later

Special mention:

> A former senior U.S. Drug Enforcement Administration official who spent three decades at the DEA, specializing in preventing the diversion of prescription drugs like OxyContin, is now paid to advise one of the largest opioid manufacturers in the country, Purdue Pharma

1 comments

Yes, I read that part. It doesn't counter any of my points, they actually enforce them.

Oxycontin was safe to use for their intended purposes, but they were not used that way. It wasn't the approval process that was problematic, just the follow-up.