Continued from page 1

c Little or no information available about the duration of a drug shortage (85 percent).

c Lack of advanced warning from manufacturers or the FDA to alert practitioners of an impending drug shortage and suggested alternatives (84 percent).

c Little or no information about the cause of the drug shortage (83 percent).

Survey respondents felt “unsupported by the FDA and are perplexed regarding why the U.S. is experiencing drug shortages of epic proportion that are often associated with third-world countries.”

Should the issues of both authority and funding for the FDA’s efforts to mitigate drug shortages be hung on the Prescription Drug User Fee Act Christmas tree, which authorizes the FDA to collect fees from companies that produce certain drug or biological products, or addressed in separate legislation? Either way, it’s an issue that must be addressed with alacrity before it becomes a question of American lives.

Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.