From the AP Wire:
Vermont Gov. Jim Douglas and his counterparts in three others states petitioned federal health officials Thursday to issue long-delayed guidelines on the production of generic versions of insulin and human growth hormone.
“We’re tired of waiting for the FDA to act,” said Douglas, speaking at a news conference in Montpelier, Vt. “It’s time for the federal government to end its foot-dragging and put the interests of Americans who need access to less expensive medications ahead of the interests of the pharmaceutical industry.”
Douglas and the others said there were no scientific reasons for delaying the issuance of the guidance documents FDA already has drafted.
Well, um, actually there are quite a few very thorny scientific questions and I’m sure the FDA would be more than willing to brief Governor Douglas, et al.
(Note to Governor’s staff: If you need the FDA’s phone number, please email me at ppitts@cmpi.org.)
Also — when it comes to follow-on biologics (there really can never be a truly generic biologic) there are also legislative questions. To that end I recommend that Governor Douglas call his congressional delegation. And how hard could that be? After all, it’s Vermont. There are two senators and only one representative.
