FDA effort standardizes patients' medical information

When patients fill a prescription, they sometimes receive multiple instructions developed by different sources that may be duplicative, incomplete or difficult to read.

The Food and Drug Administration has been working on developing regulations that would require a single document for prescription drugs known as patient medication information. This week, the Brookings Institution in Washington will convene a public meeting in which the FDA and private sector players will weigh in on the prospects for making PMI a reality.

Drug-safety advocates have long pushed for a single, clear label that tells when and how a drug should be used and provides clear side effect warnings and other useful information.

The meeting takes place against a backdrop of heightened concern about the direction of FDA drug-labeling policy. The agency faces criticism from some lawmakers and generic-drug makers for a proposed rule requiring generic-drug companies to update product labels if they receive new safety information. Generic companies currently do not have to make such changes unless the company that developed the original version of the product does so first (See p. 20).

The FDA believes the rule will make it easier for generic drug companies to pass on safety information. Generic manufacturers claim it will open them to product liability lawsuits and raise the product costs.

Follow Virgil Dickson on Twitter: @MHVDickson