Birth Trauma / Medical Malpractice

It only took 28 deaths, but our astute lawmakers in Washington are drafting legislation that would finally empower the Food and Drug Administration to regulate so-called compounding pharmacies, like the one that produced the batches of tainted steroids linked to a meningitis breakout.

According to The Wall Street Journal Friday, U.S. Rep. Ed Markey, D-Mass., was going to introduce a law mandating that compounding pharmacies, which create customized drugs, meet the same sterility and manufacturing standards as traditional pharmaceutical makers. His bill is being co-sponsored by Reps. Steve Cohen, D-Tenn., and Louise Slaughter, D-New York.

http://online.wsj.com/article/SB10001424052970204707104578093174235021886.html?mod=googlenews_wsj

Rep. Rosa DeLauro, D-Conn., also plans to sponsor similar legislation, The Journal reported. Congress is probing the fatal fungal meningitis outbreak, with a hearing scheduled for after the Presidential Election.

The brouhaha comes in the wake of 28 dying and nearly 400 made ill after receiving contaminated steroid shots, medicine manufactured by the New England Compounding Center (NECC) of Framingham, Mass. The Journal reported that on Thursday, federal health officials announced that two other NECC products had been tested and had bacteria.

Compounding pharmacies have essentially fallen through the cracks when it comes to control and safety, “governed by fragmented regulations for too long, leading to the worst public-health disaster in recent memory,” The Journal quoted Markey as saying.

As the law stands now, states are supposed to regulate compounding pharmacies, but the problem is operations like NECC have grown too large for states to effectively control, according to The Journal. And currently the FDA can inspect compounding pharmacies, but can’t make them to adhere to safe drug-manufacturing standards.

Under Markey’s proposed legislation, the FDA could regulate pharmacies “partially based on their volumes,” according to The Journal. The bill draws a distinction between pharmacies that only make small amounts of drugs for individual patients and those that manufacture large quantities for use across the nation.