FDA expands e-submissions, automates drug data

The Food and Drug Administration has proposed automating how drug companies register themselves and list their products with the agency. The Electronic Drug Registration and Listing System also would make all drug products marketed in the United States accessible in a searchable database.

The proposed rule posted yesterday is part of a broader federal effort to modernize the management of health information.

Currently, part of the list, which contains more than 120,000 drug products, is kept on paper. FDA aims to improve the quality and completeness of the drug product information the agency receives and manages.

The list contains timely information about manufacturers and specific drug formulations, including ingredients, dosage forms, strengths, labeling and manufacturer information. Drug developers and manufacturers would be required to submit establishment registration and drug listing information electronically rather than on paper.

Users of the list include other government agencies, and health care providers and payers.

"Having drug makers submit drug information electronically will help to keep an accurate, up-to-date inventory of drugs on the market. This will help us maintain more accurate information and make it easier for us to respond to drug emergencies such as recalls and drug shortages," said Health and Human Services secretary Mike Leavitt in a statement. FDA is an operating agency of the Health and Human Services Department.

The National Drug Code Directory relies primarily on drug listing information to provide details on marketed drug products. Drug establishment registration provides FDA with drug manufacturing, repacking, and re-labeling locations, and contact information. FDA uses this information to identify sites for inspection, and for other regulatory and drug safety purposes. This data is used, among other things, to identify alternate product sources during drug shortages and to facilitate drug recalls.

The proposal would change the system FDA uses for assigning marketed drugs a drug listing number, the National Drug Code, and would require drugs to display the NDC code on their label. FDA maintains the repository of NDC numbers in its Drug Registration and Listing System and publishes an extract of this information in its NDC Directory.

The proposed rule supports the implementation of broader initiatives within HHS to provide accessible electronic drug product information, such as the electronic prescribing provisions of the Medicare Prescription Drug Improvement and Modernization Act and FDA's recent rule requiring bar codes on certain drug product labels.

Separately, the Massachusetts Institute of Technology will assist FDA to automate monitoring of the safety of prescription drugs already on the market. Currently, FDA relies on voluntary reporting to track drugs’ adverse effects.

MIT’s Center for Biomedical Innovation will use methods similar to those of public health departments and HHS’ Centers for Disease Control in recognizing unusual patterns of infectious diseases in the fight against bioterrorism and pandemic influenza.

"With recent advances in bio-information sciences, it is possible to mine and analyze large sets of data to make more rapid post-market identification of safety issues that could not be identified during clinical trials," said Janet Woodcock, FDA's deputy commissioner for operations.

In addition to voluntary reports FDA receives from patients and the health care community, MIT will mine large sets of health care data to recognize patterns that indicate unexpected safety problems.

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