GTC Biotherapeutics (fka GTCB)

[RufusT]

"The FDA with is unforgivable delays in reviewing drugs, is way overdue for reform"

AMEN! By all accounts the FDA had a record year of delaying and hedging and wallowing in indecision. The likes of Kennedy and Grassley had no small hand in this lethargy but the FDA didn't need any help. An agency that regulates such a large part of our economy (one quarter by some accounts)should be thinking of ways of cooperating with industry rather than being a roadblock. As Commissioner Alexander Schmidt said back in 1974:


In all of DA’s history, I am unable to find a single instance where a Congressional
committee investigated the failure of FDA to approve a new drug. But, the times when
hearings have been held to criticize our approval of new drugs have been so frequent that
we aren’t able to count them . . . The message to FDA staff could not be clearer. Whenever a controversy over a new drug is resolved by its approval, the Agency and the individuals involved likely will be investigated. Whenever such a drug is disapproved, no inquiry will be made