FDA Wants Tougher Electronic Drug Registration Requirements

Coming on the heels of an internal report critical of inaccuracies in the FDA’s drug data system, the agency is proposing a new rule requiring drug manufacturers to electronically register all their products — prescription or OTC — in an Electronic Drug Registration and Listing System (EDRLS).

The agency Aug. 23 said the proposed rule “is part of a broader federal effort to modernize the management of health information.” However, the announcement closely followed a report issued Aug. 14 by the HHS Office of Inspector General that said the FDA’s National Drug Code (NDC) Directory is incomplete and inaccurate due to inadequate agency oversight of industry submissions and insufficient industry reporting.

There will be a 90-day period for public comments to the FDA on the proposed rule and a 30-day period for comments to the Office of Management and Budget on the information collection requirements.

Problems With the Current System

The report estimated that 9,187 prescription drug products are missing, with 5,150 listings pending. The directory also lists an estimated 34,257 products that are no longer on the market or are listed in error because companies failed to report drugs taken off the market.

“We recognize this and are attempting to remedy it,” Deputy Commissioner for Operations Janet Woodcock said at a press conference last week to announce EDRLS.

However, the FDA is “limited by what the companies submit,” John Gardner of CDER’s Office of Compliance said. “We take what they submit, and if it’s incomplete we request that they resubmit it. But if it’s inaccurate, we may not be able to detect it. We are missing information on about 10 percent of prescription drug products. Manufacturers also take products off the market or change their NDC numbers without telling us. That’s why we need semiannual review.”

The proposed rule would “give the FDA more control over the issuance of NDC numbers,” and would require that NDC codes be displayed on drug labels in “human-readable” form, i.e., using numerals, Michael Bernstein of CDER’s Office of Regulatory Policy said.

It would also require “affirmative updates” from drug manufacturers, who are currently not required to submit updates to the database if there are no changes, but would have to state explicitly that there are no changes under the EDRLS proposal.

New Efficiency

“The electronic system is not a panacea, but it will make things much tighter,” said Woodcock. “We can act against manufac- turers who choose not to tell us [required information].”

The current Drug Registration and Listing System contains each drug’s NDC number, along with information on ingredients, formulations, dosage forms, strengths, labeling and manufacturer data for more than 120,000 drug products, some of which is kept on paper. Users of the list include government agencies, healthcare providers and healthcare payers.

The FDA currently employs 15 people who work full-time on data entry of the information that drug manufacturers submit on paper, Woodcock said. Requiring drug manufacturers to submit the data electronically themselves “will free up resources” for enforcement.

To view the Federal Register notice, go to www.fda.gov/OHRMS/DOCKETS/98fr/oc94634.pdf. — Martin Gidron, Michael Causey