Inconsistent state oversight of specialty pharmacies that mix their own medicines, like the one linked to the U.S. meningitis outbreak, shows the need for greater federal oversight, Representative Edward Markey said.
State pharmacy boards focus on licensing activities and pay little attention to safety enforcement, said Markey, a Democrat from Massachusetts, where the pharmacy linked to 25 meningitis deaths is located. Markey, in a report released yesterday, said the federal Food and Drug Administration does a better job making information publicly available that may help consumers avoid dangerous medicines.
Markey plans to introduce legislation that would require compounding pharmacies to register with the FDA and comply with minimum safety standards. The move adds to other legislative proposals and two congressional investigations related to New England Compounding Pharmacy Inc., known as NECC, which this month recalled more than 17,000 vials of a steroid for back pain after tainted doses were linked to a fungal meningitis outbreak that has infected 354 people, including 25 deaths.
“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. “This tragedy demands the strongest response from Congress and federal and state authorities to ensure safeguards are in place to protect patients.”
And of course Republicans will say no new oversight is needed, and that New England Compounding will be put out of business by the hand of the free market, and that the problem solves itself, right? Surely the industry will police itself now. Which is of course, how we got into this problem in the first place.
Yeah, sure, a dozen or so people had to needlessly die, but you break a few eggs and stuff.