Tuesday, October 30, 2012

Pharmacy-made pregnancy drug under scrutiny after meningitis outbreak


By Julie Appleby, Kaiser Health News
When a brand-name drug to help prevent premature births was approved last year, its $1,500-a-dose-price alarmed state and private sector insurance officials.
Many restricted use of the FDA-approved Makena in favor of $20- to $40-a-dose versions that had been made for years by pharmacies, saying that would give more women access to the treatment. Federal officials, sympathetic to such arguments, allowed the pharmacies to continue making the unapproved drugs.
But those decisions are now getting a second look following a deadly meningitis outbreak linked to a different pharmacy-made drug that has sickened hundreds of people and killed more than 25. No one has been reported injured by the pregnancy drug knockoffs. But the judgments made about Makena offer a window into the difficult tradeoffs between cost, safety and access sometimes confronted by policymakers and insurers at a time of growing angst over drug prices.
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House Dem slams drug compounders in new report

By Elise Viebeck 10/29/12 12:24 PM ET
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. 

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