For medication safety, we rely on our doctors to prescribe and our pharmacists to dispense the right drugs. But on whom do doctors and pharmacists rely? Increasingly, the answer is drug companies. This is not inherently bad. After all, a drug company probably knows its product better than anyone, and can play a valuable role in educating doctors and pharmacists about the appropriate use of the drug. And, a central element of the FDA's drug-approval process is intended to give the drug companies a clear idea of what the drug can be marketed for and to whom it may be prescribed.
At least, that's the way it's supposed to work. A largely unnoticed news story earlier this month showed what can happen when a drug company simply ignores the FDA and, in order to maximize profits, markets its drug for conditions -- and people -- it shouldn't.
The story begins in 1997, when the FDA declared that any version of Levothroid, a hypothyroidism drug, would be considered "unapproved" unless submitted to the FDA for review and approval. The FDA gave drug manufacturers until 2000, and then until 2003, to acquire FDA approval. But Forest Pharmaceuticals, according to the Department of Justice, actually increased its efforts to sell the drug without obtaining FDA approval, even ignoring a warning letter from the FDA, all the while instructing its sales staff to "work overtime" to sell as much of the drug as possible.
But that's not all. The company was also 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 Department of Justice alleged that Forest Pharmaceuticals was engaged in the marketing and sale of "unapproved drugs." For the company, 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, 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."
How could this have happened? And how can it be prevented from happening again?
This case illustrates the importance of requiring FDA approval of prescription drugs. No government agency is infallible, and the rare occasions that the FDA makes an incorrect judgment -- think Vioxx -- get plenty of media play. But mostly, and less sensationally, the agency gets it right, reviewing thousands of medicines a year to ensure that they are safe and effective.
In some instances, it comes as a surprise to doctors, pharmacists and certainly patients that not all prescription drugs on pharmacy shelves are FDA-approved. By the FDA's own estimates, up to two percent of available drugs representing about 75 million prescriptions a year have not been subject to the FDA approval process. In some cases, these drugs may be safe and effective; but in others, they may be one and not the other. Or neither. It makes good sense to require during manufacturers to reassure the public on the safety and efficacy of their products by seeking FDA approval. The FDA has the right policy that manufacturers must follow, but the onus should be on the companies to take heed to warning letters and other FDA communications by simply going through the approval process. Additionally, pharmacy chains and distributors should take steps to make sure that they are filling and dispensing only FDA-approved versions.
Nobody should begrudge a drug manufacturer's profitability for developing a lifesaving drug. 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.
John Horton is the Founder and CEO of Legitscript.
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