Penalties against companies that don’t comply would not be very severe. FDA officials said Thursday the agency will post on its website “non-compliance” letters to companies that fail to provide enough advance notice.
“We think that putting those up would emphasize the importance the FDA is placing on timely notification,” FDA deputy director for regulatory programs, Dr. Douglas Throckmorton, told reporters.
The FDA will take comments on its proposed rule for 60 days, before revising and finalizing it.
The forces behind recent drug shortages include consolidation among generic drug manufacturers, as well as manufacturers deciding to end production of marginally profitable drugs. Many shortages are also caused by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories. Recalls of huge batches of some drugs due to contamination by bacteria, fungi and tiny glass or metal particles have exacerbated shortages.
The recent spate of recalls has forced the FDA to increasingly allow imports from foreign factories that normally don’t ship to the U.S.
While once considered an extraordinary step, the agency has been forced to allow the importation of 17 drugs to combat U.S. shortages. Most recently, the agency authorized temporary shipments from Norway of intravenous formula used to feed newborn infants, cancer patients and other frail patients who cannot eat or drink by mouth.