Why the FDA's Drug Naming Process Is All Screwed Up
Pharmacists are mixing up Johnson & Johnson (JNJ)'s antipsychotic Risperdal (generic name risperidone) with GlaxoSmithKline (GSK)'s drug for restless legs syndrome, Requip (ropinirole), in a way that shows how dysfunctional the FDA's drug-naming policy is. The FDA reported 226 Risperdal/Requip errors, resulting in 16 adverse events, five hospitalizations and one death.
Companies spend tens of thousands of dollars coming up with drug names that will meet the stringent conditions for name approval by the FDA. Brands must be unique words that sound and look different, even when written in a doctor's illegible handwriting. The intent is to avoid prescribing errors that harm patients.
But the criteria the FDA uses to decide that a drug or its name are "different" enough don't make sense, and -- as the FDA's warning about Risperdal and Requip shows -- manufacturers are not required to make their drug packaging different enough to prevent mixups. The FDA has asked J&J, GSK and various generic manufacturers to redesign their packaging and use different typefaces for the two drugs.
As you can see from the existing packaging, a bunch of companies are lazily using the same package design for all the drugs they make, tempting fate (click to enlarge). It would cost taxpayers zero dollars for the FDA to implement a new rule requiring that different drugs carry different logos and trade dress to avoid confusion. Currently, there is no such rule.
Worse, the FDA allows different drugs to carry the same name and identical drugs to carry different names -- a recipe for disaster:
- Finasteride is marketed by Merck as Propecia for hair loss and as Proscar for enlargement of the prostate.
- Sildenafil is marketed by Pfizer as Viagra for erectile dysfunction and Revatio for pulmonary arterial hypertension.
- Tadalafil is marketed by Eli Lilly as both Cialis and Adcirca, for the same indications as Viagra and Revatio.
- J&J's Zyrtec eye drops do not contain Zyrtec.
- Merck's Claritin eye drops do not contain Claritin.
- In 2010, the FDA required Novartis to stop marketing Maalox Total Relief with the word "Maalox," because the product doesn't contain any Maalox.
None of this makes any sense, and yet it would cost nothing to fix.
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