Latest Recall of Contaminated Drugs Should Spur Congress to Give FDA More Authority Over Compounding Pharmacies, Indiana Personal Injury Attorney Says

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Mike Stephenson, a partner with McNeely Stephenson Thopy & Harrold, says a Texas compounding pharmacy’s recall of a drug which may be responsible for bacterial bloodstream infections underscores the need for more government oversight and control.

Indiana Attorney Mike Stephenson

Congress can’t just keep talking about it – they need to act quickly to protect all Americans from contaminated drugs which are causing illness and death in almost every state.

An August 11, 2013, press release from the Federal Drug Administration announced the nationwide voluntary recall of all sterile products from Specialty Compounding, LLC, in Cedar Park, TX, after 15 patients at two Texas hospitals developed bacterial bloodstream infections subsequent to receiving calcium gluconate injections prepared by the company.

This is the second of such contaminated drug recalls involving compounding pharmacies in less than a year. A 2012 fungal meningitis infection that spread in contaminated vials of medicine distributed by the New England Compounding Center in Framingham, Mass., led to 63 deaths and 749 people becoming ill, according to the CDC.

The proposed Pharmaceutical Quality, Security and Accountability Act (SB 959), which would help prevent illnesses and deaths caused by tainted products of compounding pharmacies, is currently before the Senate Committee on Energy and Commerce. “This legislation would close some of the loopholes under which these compounding companies have been operating,” Stephenson said. “Congress can’t just keep talking about it – they need to act quickly to protect all Americans from contaminated drugs which are causing illness and death in almost every state.”

At their July 16, 2013, hearing on SB 959, Rep. Henry A. Waxman, Ranking Member on the Committee on Energy and Commerce, stated, “We have learned that there is a gaping hole in our drug safety laws. American families expect us to work together to develop an effective legislative response. And we need to do this as quickly as possible. We know that otherwise it will not be if another dangerous catastrophe occurs with compounded medicines, but when.”

Since last September’s outbreak of fungal meningitis, the FDA has stepped up inspections, according to US Today. “Obviously,” Stephenson said, “something more needs to be done. The FDA needs authority to more stringently regulate and control compounding pharmacies. When you’re sick or in the hospital, the last thing you need is to worry that the drugs you receive are going to give you what could be a fatal infection.”

In a statement released on August 10, 2013, Sen. Tom Harkin, Chairman of the U.S. Senate Health, Education, Labor, and Pensions Committee, said, “I am saddened to learn of yet another incident where patients have been potentially harmed due to tainted drugs produced by a compounder. The Senate has before it a unique opportunity to take bipartisan action and improve the safety of compounded drugs. I hope that the Senate takes up and passes the bipartisan Pharmaceutical Quality, Security, and Accountability Act as soon as possible so that the FDA and state boards of pharmacy can have the guidance necessary to carry out their work to protect all Americans.”

Indiana product liability attorney Mike Stephenson has been successfully litigating personal injury cases, including pharmaceutical drug injuries, across Indiana since 1981. With more than 30 years of experience working with families across Indiana, Attorney Mike Stephenson has handled litigation in 18 states and served as lead trial counsel in more than 100 civil jury trials. Visit the firm's website to learn more about class action lawsuits in Indiana.

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