Drug Safety Officer Advocates Electronic Reporting of Postmarketing Adverse Events

With new regulations expected later this year requiring esubmission of postmarketing adverse events reports, an FDA official said last week that the agency feels its pilot program is "moving in the right direction" as industry embraces the benefits of the technology.

"Currently, 50 percent of all expedited (15-day) adverse events reports are submitted electronically," said Roger Goetsch, special assistant in the FDA's Office of Drug Safety, at a Jan. 19 Drug Information Association meeting.

It is not just big companies that make up the roster of the 26 companies participating in the agency's esubmissions Adverse Event Reporting System (AERS) pilot, Goetsch noted. And the number of esubmissions in the AERS program has grown at a refreshing pace, he said. In 2002 the agency received an average 87 individual case safety reports (ICSRs) per day -- that number rose to 300 per day in 2004 and hit 500 per day last year, he said.

In addition, the new upgraded gateway accepts extensible markup language (XML) and attachments. However, challenges remain before the program will further expand, Goetsch said. Among those challenges:

Industry properly addressing the FDA Form 3500A and E2B mapping issues; Industry understanding of the basic premise of signal detection and drug-event relation; Code lists and text fields; MedDRA coding (accepting codes or text); and Lack of regulation mandating ereporting of ICSRs.

However, the program will likely continue receiving more esubmissions from more participants, Goetsch said. That increase will be fueled, in part, by forthcoming regulations on esubmissions, the new gateway accepting XML and vaccine ICSRs using International Conference on Harmonization (ICH) E2B standards beginning in June. E2B sets out transfer elements for edata and is considered the front-runner standard.

In addition, adoption of voluntary electronic case reporting to the FDA is freeing up resources to allow regulated companies to focus on interpreting clinical trial data rather than merely handling it, several noted.

And the benefits for companies only begin at the clinical trial level, said William Gregory, director of worldwide harmonization at Pfizer. Leveraging E2B as the standard of electronic exchange of ICSRs provides a valuable "continuum" that allows companies to be more efficient from clinical trials through product roll-outs and beyond, he said.

E2B is one of several electronic standards for edata transfer -- others include the electronic common technical document, and structured product labeling. Health Level Seven (HL7) is one of several American National Standards Institute-accredited standards developing organizations (SDOs) operating in the healthcare arena. Most SDOs produce standards for a particular healthcare domain such as pharmacy, medical devices, imaging or insurance (claims processing) transactions. HL7 is working to expand the use of E2B across the entire healthcare sector to speed the exchange of important safety information. The introduction of standards is widely viewed as a tool to drive down the cost of technology by, in part, creating a competitive marketplace for vendors.

E2B has become the standard for the electronic exchange of ICSRs, noted Kostas Kidos, senior director of clinical and regulatory information services at Merck. E2B is already widely used by regulators and industry and is likely to be adopted by the extended healthcare sector, Kidos added.

Other industries standardized their exchange of information decades ago, according to Kidos. "Compare E2B of 2006 to the introduction of electronic funds transfers of the 1970s," he said.

E2B also can be beneficial for a company that wants to conduct a clinical trial for a new indication for an approved drug, Kidos said. Using E2B the first time around makes it much easier, more efficient and faster to communicate subsequent results with the FDA, he said. It creates information collection mechanisms that make it far easier for agency investigators to access and interpret new data.

In addition, use of E2B in a well-integrated drug development infrastructure helps to eliminate the "middleman" when transmitting trial data among call centers, contract research organizations, partners and others, Kidos said. That same data can be sent directly from investigators to other recipients in the same format, eliminating the need for costly and time-consuming reconciling, he added.

"Via the use of E2B, industry can reduce its cost of manually collecting, processing and reporting safety information and redirect its investment in understanding its meaning," Kidos said. Another potential bonus: Use of underlying vendors and a certain technology becomes irrelevant allowing for less expensive systems integration, Kidos said. -- Michael Causey