September 28, 2005 -- FDA to Provide ‘Better Medical Information’

The Deputy Commissioner for Medical and Scientific Affairs of the federal Food and Drug Administration (FDA) today announced that beginning in November, health care professionals and patients will be able to access up-to-date information on medications on the Internet, free of charge, through a “Daily Med System” that will distribute and display medication information. Calling the new service “a monumental change in the way medical information is made available,” Dr. Scott Gottlieb said a key element of the Daily Med will be the electronic product label known as the package insert, the onion-skin piece of paper folded up inside the tops of pill bottles. “Right now,” Gottlieb said, “the content and format of these paper labels is not conducive to easy accessibility, and they are not easy to search for pertinent information, or even to find on the web.” He also said that beginning next month, the FDA will require drug makers to start submitting label changes electronically, facilitating prompt updating of label information. “Imagine a world where product labels can be pulled off the web, or better yet, off a PDA that doctors carry in their pockets, that is updated instantly each time new safety warnings are added or new information about a drug’s benefits. Doctors could receive special alerts for the drugs they are most likely to prescribe.” Gottlieb also noted that the FDA is now requiring bar-codes on the labels of all prescription drugs and over-the-counter medications. He explained the new services and requirements in a briefing for the press, saying “At FDA we’re making some new commitments to work more closely with reporters. If we’re going to remain the world’s gold standard for drug safety and drug evaluations, we need to do a better job of telling consumers what we’re finding.”