FDA in July challenged a House Committee on Oversight and Government Reform report that said its regulations and enforcement actions contribute to drug shortages.
The agency wrote ranking member Elijah Cummings, D-MD, contending that it works with manufacturers to resolve problems but cannot solve the drug shortage problem alone.
“The long-term solution to this problem requires a significant commitment on the part of drug manufacturers to invest in their infrastructure and to keep FDA informed about potential manufacturing and quality problems,” the agency wrote.
“To be clear,” the letter says, “it was the manufacturers who made the determination to stop producing drugs. FDA… worked with each of them to try to avoid a shutdown.”
Between 2008 and 2011, when there was a big increase in drug shortages, the level of Warning Letters issued each year for deficiencies in the manufacture of human drugs or biological products was relatively flat. This is in contrast to the report's allegation of a dramatic increase in the number of Warning Letters.