In wake of meningitis scare, congressman targets pharmacies
Published: Thursday, November 1, 2012 at 2:44 p.m.
Last Modified: Thursday, November 1, 2012 at 2:44 p.m.
FRAMINGHAM, Mass. — A Massachusetts lawmaker said Thursday that he will introduce legislation to increase federal oversight over specialty pharmacies like one linked to a deadly meningitis outbreak.
U.S. Rep. Ed Markey made the announcement outside the now-closed New England Compounding Center in Framingham. A tainted steroid made by the pharmacy has caused an outbreak that's spread to 19 states, sickening 377, 28 of whom have died.
Compounding pharmacies custom-mix solutions that generally aren't commercially available. They aren't regulated by the U.S. Food and Drug Administration.
Under Markey's legislation, to be introduced Friday, compounding pharmacies would be regulated by the FDA if they operate like a drug manufacturer by producing larger quantities of a drug for general distribution. Officials say that's what NECC appeared to be doing, though its state license allowed it only to produce drugs for individual patients with valid prescriptions.
The bill also forbids compounding pharmacies from producing copies of commercially available drugs.
And it would require pharmacies to label compounded drugs to show they haven't been tested by the FDA.
The legislation is modeled on a 1997 law that was later struck down, though Markey said it's been modified to pass legal muster.
It allows the FDA to waive the requirement to produce drug only for individual patient prescriptions, if there's a shortage of that drug. Waivers are also available for the prohibition against producing copies of commercially available drug, if needed to protect public health.