FDA Reviewing Rules on Drug Manufacturing

The Food and Drug Administration is looking at revamping rules for safe drug manufacturing for the first time in 25 years.

The move comes as major medical factories have failed to meet current standards of quality manufacturing, including factories belonging to Johnson & Johnson, Eli Lilly & Co. and Schering-Plough Corp.

The FDA said its changes would modernize the way it inspects medical factories and allow pharmaceutical companies to make better use of new technology that could improve quality control.

FDA drug chief Janet Woodcock cited fully automated manufacturing systems that some U.S. drug makers use in factories in Europe and other countries--but not here--that contain sensors embedded in different steps. Those sensors could tell if a batch of pills or powders has an ingredient wrong, for example.

The FDA likes the promise of that technology, but drug makers say the government’s decades-old manufacturing rules made it too hard for them to adopt it in their U.S. factories.