FDA Failed to Track Substandard Generics

FDA Failed to Track Substandard Generics, Congress Told – Bloomberg

The Food and Drug Administration has failed to monitor the effectiveness of generics that make up 80 percent of medicines sold in the U.S., according to doctors and researchers who said new regulatory efforts aren’t enough.

The FDA has begun a $20 million generic-drug testing effort working with academic centers, Bloomberg News reported last week. At the same time, Commissioner Margaret Hamburg said during a visit to India this month that the FDA will increase the number of plant inspections it does there. Several speakers at the briefing said these steps, along with a training program for government regulators in India, aren’t enough to ensure that copycat medicines used in the U.S. are safe.

These are the drugs we’ve been taking – and having problems with – all these years, so it’s about time the FDA stepped in to validate their supposed “equivalency”.  There is after all a reason generics can be up to 90% cheaper than brand name medications.

The FDA has banned four plants in India over the past nine months from exporting generic drugs to the U.S. It’s a country,Bate said, that’s making “an amazing array of products. This should be, and I think is, an increasing concern for all of us.”

Problems with generic effectiveness aren’t “generally known in the cardiology community,” Lever said. “If you talk to individual cardiologists about this they’ll say ‘Yeah, I had a few patients that this didn’t work.’”

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