By Elise Viebeck - 10/29/12 04:24 PM EDT
"Absent clear new statutory authority, FDA's efforts will ultimately be constrained by gaps in regulatory authority and thwarted by an industry that has historically resisted a federal role for the oversight of its activities," the report states.
Markey has promised to introduce legislation that would enable greater oversight of compounders. The New England Compounding Center (NECC), which distributed the tainted steroid injections that have killed 25 and sickened hundreds, resides in his district.
"The tragedy of NECC is clearly just the tip of an industry iceberg that has long needed reform and federal oversight," Markey said in a statement Monday.
"This tragedy demands the strongest response from Congress and federal and state authorities to ensure safeguards are in place to protect patients."
The FDA has noted instances of compounders using unsafe or unapproved ingredients and disregarding good manufacturing practices on maintaining sterile environments, according to Markey's report.
The industry has argued that its practices are safe.