A major critic of the guidance, Rep Henry Waxman (D-Calif), chair of the House Committee on Energy and Commerce, urged the Obama administration “to carefully reexamine” the policy. Waxman accused Bush’s political appointees of giving drug companies “a long-coveted parting gift.”
“Despite revelations that drug companies manipulate medical journal articles to exaggerate the benefits and downplay the risks of their drugs, the guidance gives companies a green light to promote unapproved uses of their products by handing out these journal articles,” he said. “This fundamentally undermines the requirement that companies prove to the FDA that each new use is safe and effective.”
If I may enlighten Mr. Waxman: When the FDA approves a drug they have already determined, within rather narrow though not infallible limits, that the drug is safe and effective; off-label use is an attempt to leverage that approval to treat additional ailments that are currently inadequately treated by approved medications. Waxman seems to operate under a sophisticated moral guidance system: Drug companies bad, FDA good. The pace of innovation in Medicine is already much slower than our technological progress would suggest it should be because of our regulatory environment. If drug companies are going to be required to spend billions to justify off-label uses of their products, even greater stagnation will ensue.Yes, but it'll be stagnation that Waxman & Co. will be in charge of; and even if it screws things up, they want desperately to be in charge of it(and anything else they can be). And when they screw things up, why, they'll blame the companies(again) and threaten them(again) and deny any culpability in screwing it up.
Kind of like Barney Frank & Co. and the Fannie & Freddie mess.