Saturday, October 19, 2013

Harkin has “fingers crossed” for bill regulating compounding pharmacies

Democratic Senator Tom Harkin is hoping a Republican senator from Louisiana withdraws his objection or “hold” so senators can vote on legislation that would install new federal oversight of so-called “compounding pharmacies.”

“A bill that will solve the problem of these compounding drugs that killed so many people, made so many people sick,” Harkin says.

Over 700 Americans were sickened and more than 50 died last year of meningitis traced to a Massachusetts pharmacy that mixed a steroid medication and sent the drug to clinics and hospitals in 23 different states. Pharmacies that mix injectable drugs, creams and other medications have been policed by state officials, but the bill Harkin has helped craft would give the U.S. Food and Drug Administration the authority to inspect pharmacies that mix drug compounds and ship them across state lines. The bill also establishes national standards for compounding pharmacies.

“That would be a nice victory to have and we worked very hard on that this year, pulling it together. We had hearings on it and we had a good bipartisan vote on it in my committee so I’ve got my fingers crossed,” Harkin says. “We’ll see.”

Lobbyists for the nation’s 7000 compounding pharmacies have successfully scuttled previous efforts to establish federal regulations for the facilities. Compounding pharmacies have traditionally been places where drugs have been mixed for a single patient with a prescription, but the growing demand for special formulations of drugs has led to large-scale production at some compounding facilities. More than 14,000 patients got injections from the three contaminated batches of steroids from the compounding pharmacy in Massachusetts that was shut down after the meningitis outbreak.

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