Zofran Lawsuit News: FDA Sets Meeting to Review Off-Label Drug Promotion Rules
The U.S. Food & Drug Administration (FDA) will soon hold a meeting to discuss its regulations pertaining to off-label drug marketing, amid growing complaints from pharmaceutical companies that the agency’s current rules violate their First Amendment rights. The meeting may be of great interest to Zofran lawsuit plaintiffs, who have accused GlaxoSmithKline of improperly marketing the anti-nausea drug as an off-label treatment for morning sickness.
Doctors are permitted to prescribe FDA-approved medications for any purpose they see fit. But drug makers are currently prohibited from touting off-label uses in marketing materials for their drugs. The FDA said earlier this month that it would convene a public meeting this summer to address drug company concerns, but has not yet set a date for the event.
Off-Label Drug Marketing
According to a report from Reuters, Glaxo is among a number of drug makers that have been accused in the past of flouting the FDA’s rules on off-label promotion. In 2012, the company agreed to pay $3 billion to settle improper marketing charges with U.S. Department of Justice, including allegations that it had promoted Zofran as a morning sickness remedy, even though the medication has never been approved for this purpose.
Pharmaceutical companies aren’t completely banned from discussing off-label use. For example, the FDA permits drug makers to provide doctors with data from well-controlled clinical trials that have been published in reputable medical journals and reference texts. They may also dicuss off-label indications at medical conferences, and answer physician questions about such uses as long as they discloseassociated risks. But according to Reuters, drug companies say they should be able to dicuss data that does not come from clinical trials, and they want to provide economic analyses to insurance companies showing why a medication should be covered.
While the FDA has proposed some changes to appease the pharmaceutical industry, drug companies assert that the agency’s proposals don’t go far enough. Meanwhile, patient advocates are calling on the FDA to proceed with caution.
“If off-label marketing is allowed then drugs will come to be used for a wide variety of conditions for which there has not been developed evidence of safety and efficacy,” Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, told Reuters. “You take away those checks and balances and it’s the wild, wild west.
Zofran Lawsuits and Off-Label Use
Zofran lawsuit plaintiffs who are suing GlaxoSmithKline over birth defects allegedly caused by the medication cite the company’s 2012 federal settlement to back allegations that the drug maker wrongly marketed the medication to treat nausea and vomiting related to pregnancy. Among other things, they claim that Glaxo misrepresented the drug as being safe and effective for that purpose, even though the company had never conducted human testing to determine its effects on a developing pregnancy.
Zofran is only approved to treat nausea and vomiting related to surgery or certain cancer treatments. However, an analysis published in 2014 suggested that as many as 1 million pregnant women are prescribed Zofran or generic equivalents every year to alleviate pregnancy-related nausea and vomiting.
Children who were born with oral clefts, heart defects, or other birth defects that could be associated with pre-natal Zofran exposure may be entitled to compensation from Glaxo. To learn more about filing a Zofran lawsuit, please call 1-877-779-1414 today.