Makers of generic drugs are not required to warn patients if they receive reports of new side effects from the drugs, according to a new Supreme Court decision. This ruling protects generic drug makers from being sued under state liability laws for failing to warn patients of these new dangers.
Comparatively, makers of brand-name drugs are required to report any adverse events associated with their medications to the Food and Drug Administration (FDA). These possible side effects are included in an FDA-approved safety label that tells doctors and patients of the possible adverse events.
The brand-name drug company has exclusive rights to the sale of that drug until its patent runs out, which opens the market for other drug companies to sell FDA-approved generic versions of the drugs. About 75 percent of prescriptions written in the United States are for generic drugs, which are often much less expensive than the brand name.
Because the FDA must approve changes on each drug’s warning label, Supreme Court justices ruled that generic makers are not liable for failing to warn patients of new dangers. This decision throws out lawsuits from two women who developed a severe involuntary movement disorder known as tardive dyskinesia after taking metocloparmide, a generic version of the acid reflux medication Reglan. Reglan had been on the market for years before it was found that long-term use (12 weeks or longer) of the drug put users at risk for the neurological disorder.
The Supreme Court also ruled that pharmacies, drug makers and others had a free-speech right to buy private prescription records to bolster their marketing efforts to doctors. “Information is speech,” Justice Anthony M. Kennedy said. “If pharmaceutical marketing affects treatment decisions, it does so because doctors find it persuasive.”