By Michael Ollove
Without the medicine Rachelle Crow takes for her rheumatoid arthritis, the 29-year-old Michigan woman’s face would frequently feel as if it were engulfed in flames. She would barely be able to crawl out of bed. She would have trouble opening or closing her fists or lifting her 3-year-old daughter.
Crow can do all those things thanks to Cimzia, one of a highly complex, usually expensive class of drugs known as biologics that derive from living organisms. Cimzia is recommended for women, like Crow, who are trying to get pregnant.
Notification laws require that patients and doctors are told whenever “biosimilar” imitations are substituted for brand-name biologics
.What keeps her up at night is a fear that a pharmacy could substitute a cheaper, not-quite identical drug for Cimzia without her or her doctor’s knowledge. It’s not only a return of her worst symptoms that she worries about. “If another medicine were substituted without telling me or my doctor, it could put my pregnancy at risk,” she said.
Fears like Crow’s have helped propel legislative attempts in many states this year to make sure that patients and doctors are notified whenever imitations deemed “interchangeable” by the US Food and Drug Administration (FDA) are substituted for brand-name biologics.
Already, Colorado has passed a notification law, and Utah has revised its earlier law. More than a dozen states are considering comparable measures.
Notification bills began popping up in states two years ago, but most were defeated in the face of opposition from manufacturers of biologic copies, which are called biosimilars, and from organizations representing pharmacists, who objected to the extra workload notification requirements might entail. Continue reading