Posted in Education, FDA, Government Regulations, Medical Costs, Patient Safety, Policy Issues, Technology, U.S. Security, Uncategorized

Is that a Centipede I See in My Capsule?? | MedPage Today

Eban: They knew I was coming. They had let me come in, but I saw a very different world within these plants through whistleblowers. I worked with a lot of whistleblowers who had contacted me — or I had made contact with them — who were showing me documents, showing me photographs, giving me really the sort of gory details of what was happening in these plants and the kinds of crazy decisions that were being made like failing drugs, drugs that had glass particles in them were being approved to be dispensed. Broken down, rusted equipment that was leaving metallic fragments in pills. Those were being dispensed.

Illicit use of ingredients. You can’t just swap ingredients. But they had drugs that were dissolving improperly, so they just haphazardly changed things up to try to get better data to show the FDA. All of this was taking place in a kind of lawless regulatory environment. They’re not afraid of their own regulators. They’re afraid of the FDA, but what they have built is an elaborate system to trick the FDA. Our FDA has all but volunteered to be tricked because we announce our inspections in advance overseas. We give 3 months’ notice. They send in data fabrication teams.

https://www.medpagetoday.com/podcasts/anamnesis/84501

Author:

A primary care physician by training, my passion is researching and writing about the importance restoring patient centered care, supporting independent private physicians, promoting free-market solutions and seeking sustainable fiscal policy in healthcare.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s