About a week before the climate in Washington, D.C., turns inside out, FDA officials have ushered in new rules that will make it easier for drugmakers to distribute journal articles supporting off-label uses of their products.
Yes, the long-promised change in guidelines has been finalized. Companies will be able to pass out articles published in peer-reviewed medical journals, even if those articles promote drug uses that aren't sanctioned by the FDA. Pharma types say the rules aren't new at all, just a recodification of regulations allowing the practice, which expired in September 2006. Drugmakers have been fighting for its return ever since, the Associated Press reports.
But some lawmakers have been fighting back, and they're still doing so. "In the final hours of this administration, political appointees at FDA have given drug companies a long-coveted parting gift," said Rep. Henry Waxman, new chairman of the influential House Committee on Energy and Commerce, which oversees pharma. "This fundamentally undermines the requirement that companies prove to FDA that each new use is safe and effective."
Will those regulations be revoked as quickly as they were reinstated? Quickly, of course, is a relative term in Washington. So drugmakers should have enough time to get their current favorite articles in doctors' hands.
- read the AP story