What happens when a drug company ignores the FDA’s requirements for drug safety and efficacy? Today, LegitScript’s President wrote a blog in the Huffington Post, where he is a frequent contributor, about a recent case involving Forest Pharmaceuticals, in which the company agreed to a more-than-$300 million fine.
As noted in the HPost blog:
(Forest Pharmaceuticals) was accused of marketing Celexa and Lexapro, two anti-depressants, for pediatric use, in spite of the fact that these were not FDA-approved for children. According to the US Department of Justice, the company had conducted two studies as to the drugs’ safety, one of which exposed safety risks to children, but the company only promoted the study failing to disclose the safety risks.
For marketing Levothroid without FDA-approval and marketing Celexa and Lexapro for pediatric use, the result was over $300 million in fines and fees, and an as-yet unresolved civil case in which the company is a defendant. And, quoting from the blog:
…not inconsequentially, the moral stain of having promoted a drug as safe for kids that was not, in the prosecutor’s own words, “approved to treat children.”
Nobody should begrudge a pharmaceutical company that developed a life-saving drug from profitability. But in return, patients should demand that drug companies adhere to the FDA’s rules for drug safety and marketing. They must put people, not profits, first.