Markey's Legislation to Be Introduced Friday and To be FDA-Regulated if Large Producers

Under Markey’s legislation, to be introduced Friday, such pharmacies would be FDA-regulated, if they produce larger quantities of a drug for general distribution. Officials say that’s what the company appeared to be doing, though they were only permitted to produce patient-specific prescriptions.

The bill also requires pharmacies to label compounded drugs to show they haven’t been FDA-tested.

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Mass. lawmaker seeks greater pharmacy regulation

By JAY LINDSAY

Associated Press / November 1, 2012

 FRAMINGHAM, Mass. (AP) — A Massachusetts lawmaker says he'll introduce legislation to increase federal oversight of specialty pharmacies like the one linked to a deadly meningitis outbreak.

Democratic U.S. Rep. Ed Markey made the announcement Thursday outside the now-closed New England Compounding Center in Framingham.

A tainted steroid made by the center caused a fungal meningitis outbreak linked to 28 deaths across the country.
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Pharmacy Compounding: Federal Law in Brief

by Jonathan J. Darrow

Until recently, most ordinary people had never heard of “pharmacy compounding.”  Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled drug compounding to the national spotlight (see, e.g., Denise Grady et al., Scant Oversight of Drug Maker in Fatal Meningitis Outbreak, N.Y. Times, Oct. 6, 2012).

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FDA & Compounders: More Oversight Needed?

1 day ago by editor
By Ed Silverman

ver the past two years, compounded medications have figured in two highly controversial episodes. In one instance, Roche attempted to prevent ophthalmologists from using its older Avastin med for treating wet macular degeneration when its newer and more expensive Lucentis is the only approved treatment. The drugmaker has claimed that rejiggered vials of Avastin pose a safety risk (readhere and here).

In another, KV Pharmaceutical caused a huge ruckus by initially charging $1,500 for its Makena premature birth drug and trying to use its FDA approval under the Orphan Drug Act to prevent compounding pharmacies, which charged a fraction of the price, from competing. The move outraged physicians, among others, who maintained the compounded versions were safe and kept a lid on rising healthcare costs.

Now, an outbreak of meningitis that has been traced to a compounding pharmacy in Massachusetts has, once again, placed compounding in the spotlight, and renewed debate about the extent to which oversight is sufficient. The outbreak, which has left five people dead and another 30 in various stages of illness across six states, appears to have been caused by a compounded steroid drug contaminated by a fungus.

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