Adverse Event Reporting System Will Track Company Compliance With Regs

FDA's Adverse Event Reporting System will generate standard compliance reports enabling the agency to determine whether companies are submitting reports according to regulations.

At the Regulatory Affairs Professionals Society in Washington, D.C. Oct. 27, Prescription Drug Compliance and Surveillance Division Adverse Drug Reaction and Compounding Team Leader Fredric Richman said the standard compliance reports will "enable [the] Office of Compliance to identify firms that are submitting incomplete reports, or reports not submitted in a timely manner."

From these reports, the office also will be able "to identify firms failing to submit ADE reports despite having received a corresponding report from a health care professional," Richman continued, as well as identify companies "that have been inappropriately submitting data for serious reactions as periodic reports rather than 15-day expedited reports."

"Most importantly," Richman concluded, is the ability to "identify applicant holders who have never submitted any ADE reports."

AERS will assist in compliance efforts by allowing the Office of Compliance "to make ad hoc queries into the database to address any special compliance needs that might arise," such as searches of specific drugs, drug classes or periods of time.

"If some adverse event doesn't fit neatly into some specific category, then try to follow the spirit of the regulations, and make a report," Richman urged industry. "Make a sufficient investigation to get the information needed to make that report."

Office of Compliance Postmarketing Adverse Drug Reaction Manager Nancy Haggard noted that although "the great majority of companies are complying with the postmarketing ADR regulations...for a very small proportion of firms, inspection has found serious problems in which not all adverse events were reported timely, or were not reported accurately."

Haggard emphasized that FDA's ADR reporting compliance program, which already has been revised twice since June 1997, is an "evolving" concept. "We are already thinking about the next revisions," she said.

FDA has increased the number of ADR report inspections in the last couple years, Haggard noted, and has advised firms to be aware and prepared.

The agency is also receiving ADR reports at an increasing rate, Office of Postmarketing Drug Risk Assessment Deputy Director Ralph Lillie said, citing close to 250,000 total foreign and domestic reports received from all sources in 1998 so far. That number is up from approximately 190,000 reports in 1997.

In its first year, AERS has encountered start-up problems that fall into two categories, Lillie indicated. Performance problems are in the process of being improved by the creation of additional data space, while data entry issues are also being addressed.

Electronic submissions will facilitate the process, Lillie said. An industry task is attempting to get as many companies as possible to participate in the pilot program.

To date, 11 companies are participating in the electronic submission pilot program: Glaxo-Wellcome, Zeneca, Schering-Plough, Sanofi, Bristol-Myers Squibb, Pharmacia & Upjohn, Merck, Lilly, Roche, DuPont and TAP.

The companies involved are at various stages of the program, with Glaxo and Zeneca having participated the longest. "Near the top we have people who have...actually submitted data," Lillie said. More of the companies are expected to submit data in 1999.

Lillie described four safety rulemaking documents in development. An ADR reporting proposed rule continues the process of integrating the International Conference on Harmonization changes into a regulation. A separate ADR reporting proposed rule for OTC drugs is being prepared.

An advance notice of proposed rulemaking on electronic ADR submission will be "our first effort to lay out our thinking so everyone can see what we're proposing" for electronic submissions, Lillie explained.

FDA is also preparing a Postmarketing Safety Reporting Guidance aimed at consolidating 1992-1993 guidances and final rules, and "additional information that's evolved. [We're] trying to put this in one place so it's not so confusing," Lillie said.