FDA Proposes Electronic Registration of All U.S. Drugs
Modernized system would improve public access to data and speed responses to drug emergencies
THURSDAY, Aug. 24 (HealthDay News) -- In its ongoing drive to modernize health data management, the U.S. Food and Drug Administration proposed a new rule on Aug. 23 that would require drug companies to register themselves and their products electronically.
The Electronic Drug Registration and Listing System would allow government agencies, health care providers and consumers to electronically access a complete list of all drugs sold in the United States, according to an FDA statement. Currently, some of that list, which includes data on more than 120,000 drugs, is kept on paper.
Electronic drug registration would improve accuracy of data and speed the government response to drug recalls, drug shortages and other emergencies, Health and Human Services Secretary Mike Leavitt said in a prepared statement.
"The conversion to an electronic system will make the registration and listing process more efficient and effective for industry and the agency," Janet Woodcock, FDA Deputy Commissioner for Operations, said in the statement. "By providing FDA better-organized and more reliable information about drugs in the market place, this initiative also supports the agency's continuing efforts to ensure the safety and quality of drugs in the United States."