Do we have any hard data to suggest that generics are somehow unsafe?
As I said, the Ranbaxy saga. It shows that even when there’s a whistleblower from the manufacturer that tells the FDA that a manufacturer is fraudulent it takes the FDA years to do something about it.
* i.e. not some Indian blackmarket knock-off that isn’t FDA/EMA approved
The approval consists of believing the company that the studies they provide are true. The FDA doesn’t have subpoena power over Indian factories producing generics and it doesn’t do independent quality checking beyond believing the companies.
As I said, the Ranbaxy saga. It shows that even when there’s a whistleblower from the manufacturer that tells the FDA that a manufacturer is fraudulent it takes the FDA years to do something about it.
The approval consists of believing the company that the studies they provide are true. The FDA doesn’t have subpoena power over Indian factories producing generics and it doesn’t do independent quality checking beyond believing the companies.