“Although FDA can work closely with manufacturers to help resolve the problems and get back online, FDA alone cannot solve the drug shortages crisis,” the FDA said. “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 that potentially could lead to shortage situations.”
The House Committee on Oversight and Government Reform released the report, called FDA's Contribution to the Drug Shortage Crisis, in mid-June.
The FDA's letter is addressed to Rep. Elijah Cummings (D-Md.), a ranking member of the committee who is expected to testify before a Senate committee Wednesday about gray-market distributors and their role in selling and buying drugs in short supply.
The report found that the FDA's regulatory actions shut down 30% of total manufacturing capacity at the four largest generic drug manufacturers in the U.S. It recommended that the FDA allow facilities to make improvements under its supervision rather than shut down manufacturing lines.
“While such a response may place inconvenient burdens on the FDA's bureaucracy, greater use of such a targeted approach would have significantly diminished the public health crisis the country is facing from the abundant number of drug shortages,” the report said.
The report also attributed drug shortages to the market structure of group-purchasing organizations and the Medicare Modernization Act, which reduced prices for some generic drugs.
