House Dem slams drug compounders in new report

Compounding pharmacies were responsible for deaths before the current outbreak of meningitis, one House Democrat charged Monday.

Rep. Edward Markey (D-Mass.) released a report that chronicles the rise of compounders, which remix medicines for patients with special needs, and the patchwork of regulations that applies to them.

Markey's report alleges that at least 23 patients have died and 86 have been seriously sickened or injured as a result of medications distributed by compounding pharmacies in recent decades. 

The report builds a case for stricter Food and Drug Administration (FDA) authority over compounders and charges the industry with evading attempts at oversight.

"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.

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