As the Bush administration winds down, its agenda has brought some not-so-conservative results for drug marketers.
The most startling of these is surely the deal cut in this FDA Amendments Act under which the FDA is now conducting a limited-time offer, promoted in the Oct. 25 Federal Register, to companies planning to advertise on TV next year. Basically, it touts: Hurry in now, tell us within 30 days because if we don't receive $11.5 million upfront in user fees, the new law's voluntary DTC ad review program won't even begin.
Since the GOP's trust-busting Teddy Roosevelt signed the FDA into law in 1908, that has hardly been the kind of message we expect from a federal agency.
After all, the dictionary definition of “conservative” is to maintain the existing or traditional order, and to oppose change.
But radical change is what we have. In addition to DTC ad reviews up for sale at the FDA, think about the Bush campaign to preempt state laws on drug labeling. Preemption in principle nevertheless undercuts the traditional Republican value of leaving regulation to the states.
Oddly, those federally preempted states have been reacting aggressively, with New Hampshire enacting a Prescription Restraint Law that bans the collection and disclosure of info about prescribing practices, and other states cracking down on drug company gifts to doctors.
Larger and more polarizing issues will dominate the coming political year, but based on the Bush era's domestic agenda I suspect that it might be the Republicans who will project the “party of change” image, while the Democrats try to resurrect TR's old tradition.
Change is the only constant, as they say, but to me the Bush era has been conservatism stood on its head!
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)