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FDA Plans Public Meeting Regarding Off-Label Medication

A public meeting was scheduled by the FDA to discuss a push by pharmaceutical companies to streamline the release of new drugs, bypassing some measures protecting against the kind of off-label marketing that contributed to Zofran birth defect problems.

Wednesday, August 5, 2015 - In response to Zofran claims around the country and similar lawsuits, the U.S. Food and Drug Administration (FDA) planned a public meeting to address issues related to the use of off-label marketing for pharmaceuticals. The meeting, scheduled to take place in 2015, will address the movement by pharmaceutical companies to relax language that prohibits them from a number of marketing measures related to off-label endorsements for their medications.

The meeting is taking place in conjunction with a new bill entitled 21st Century Cures, which is attempting to make the process for new drugs to be introduced to the market simpler for manufacturers. Pharmaceutical companies are attempting to ease the FDA regulations on off-label drugs and how they are allowed to be marketed to patients. The current system does not allow for manufacturers to market the drugs for uses that are not either stated on the label or passed FDA approval. The pharmaceutical companies intend the new bill to give them more leeway in terms of the amount they can advertise the benefits of drugs for uses aside from what they have been approved for.

This movement by the companies is relevant to the current Zofran lawsuits currently being filed nationwide, as these cases are claiming that the off-label marketing of the anti-nausea medication led to birth defects for the children of pregnant women than were prescribed the drug. Over a dozen lawsuits have filed charges alleging similar claims, with the birth defects ranging from cleft lips to deadly heart abnormalities.

The plaintiffs in the Zofran lawsuits claim that GlaxoSmithKline, a major pharmaceutical manufacturer that settled with the Department of Justice for $3 billion over off-label charges filed against the company in 2012, marketed Zofran to help treat women experiencing morning sickness symptoms during pregnancy. The medication, which was approved by the FDA for a number of uses including staunching nausea due to chemotherapy, was never approved or tested by the FDA for use during pregnancy.

This type of off-label marketing is the type of measure that is supported in the 21st Century Cures, and the dangers it can pose to patients spurred the FDA to hold a public meeting to discuss the plan's pros and cons. The plaintiffs in the lawsuits claim that the off-label marketing violated their right to know the effects the drugs would have on them, which should have been listed on the warning label. The lawsuits claim that as a result of the off-label marketing, the testing that could have prevented the birth defects from developing during pregnancy were ignored and led to irreparable harm to a steadily growing number of plaintiffs.

Plaintiffs also claim that GlaxoSmithKline, if not initially aware, eventually learned of the serious affect Zofran was having on pregnant mothers and chose not to warn patients of the birth defect risk associated with the medication. This claim is repeatedly referenced in the lawsuits along with the failure to warn allegations against the British pharmaceutical company.

GlaxoSmithKline recently filed for the lawsuits to be consolidated into multidistrict litigation. The claims have come from states around the country and the defendants believe that centralizing them before a single federal judge will help the overall efficiency of the litigation.

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Onder, Shelton, O'Leary & Peterson, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. Onder, Shelton, O'Leary & Peterson has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.