Michael, thanks for your comments.

Like many others, you are assuming everything is done via the legislature. Nothing could be further from the truth. In fact, legislators had little to do, really, with the 'no reporting of negatives' change in the FDA. It was, basically, a tacit agreement between opposing parties as a method to eliminate the backlog of requests for approval. ???Yeah, that's what I thought, too.

Somebody really wasn't thinking when they essentially gave away their only reason for the FDA to exist...to protect the public. There's no protection for the public when the offenders/guilty parties don't have to acknowledge problems in the reports or anywhere else. Anything the government has to do with it was subsequent to the real deal...just a rubber stamp with no more thought than an 'oh, okay'...

BTW, it has been stated that the Big Pharmas put through deals they really don't care about, at little or no cost, as part of the deal so the FDA can show that they're 'doing their job' when they deny the request. It's a cover up for their inefficiency and ineffectiveness. Better watch those feet under the table...they're playing footsie!

Sandi Bowman