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ADVERSE DRUG REACTION REPORTING DISK FOR COMPUTER TRANSFER OF MATERIAL IS AVAILABLE FROM FDA; AGENCY IS ENCOURAGING ELECTRONIC DATA TRANSFERS

Executive Summary

FDA is making a floppy disk available with the 1639 adverse drug reaction reporting form to encourage computerized submission of drug reports, Gerald Faich, FDA's director of the Office of Epidemiology & Biostatistics, told the Food & Drug Law Institute on Dec. 11. "We've now put the 1639 format on a floppy disk that is compatible with all IBM setups," Faich reported. The agency will "make that [format] available to anybody who hasn't already computerized," the FDAer observed. Faich said the agency is also "very anxious" to get people to think about electronic transfer of periodic reports. In the postmarketing area, Faich said, the agency has "come a very long way." He maintained that "we've had some quite good success in that area." FDA is approaching the level of 75,000 adverse reaction reports per year, Faich told FDLI. He said that increases prior to the NDA Rewrite indicate that FDA's regs alone are not the cause for the increased reporting. In a study released earlier this autumn, GAO found that the agency was receiving about 40,000 ADRs per year ("The Pink Sheet" Oct. 20, T&G-8). The difference between Faich's figures and GAO's presumably represents the sharply rising number of reports. The changes in reporting regs may be causing too many 15-day reports, Faich suggested. In one recent three-month period, the FDAer said, the agency received almost 14,000 reports and about one-third of those reports were 15-day reports. "Something's wrong there," Faich said. "I would suggest that tells me that the regs and the guidelines as written are too sensitive, or put another way, they are not sufficiently specific." Faich also said that a "surprising" number of the adverse reaction reports are of foreign origin. He pointed out that 13% of one sample group were from foreign sources. He added that foreign reports may be a "growing proportion." Roche President Lerner Tells FDA Group That Foreign ADR Reporting Is An Improvement Hoffmann-LaRoche President Irwin Lerner commented on the use of foreign adverse reaction data during a recent meeting with FDA staffers. He told a seminar in late October that the reporting of foreign adverse drug reactions (ADRs) to FDA's ADR tracking system "is a good thing." Responding to a question on any modifications Roche has made in the way it maintains postmarketing surveillance and reports ADRs, Lerner said that "one of the major changes has certainly been the incorporation of global information, as opposed to just U.S. information, in the database that's being reported." That change "is by an FDA requirement, which is a good thing," Lerner maintained. The Roche exec indicated that FDA's revised regs for reporting are helping to improve postmarketing surveillance of drug reactions. "In terms of the ability of human beings to develop reasonable, comprehensive, timely, and accurate systems, I think the industry's in pretty good shape . . . and getting better all the time," Lerner said. "We are working very closely with the FDA people responsible for this difficult area to manage." Lerner is the chairman of the PMA board committee investigating ways to improve working conditions and the NDA review process at FDA. His appearance at a recent agency seminar was part of an effort to increase top management awareness of the situation at the working levels in FDA and to allow FDAers to ask about PMA's suggestions for improvements. Like Faich, Lerner also highlighted the role of computer tracking in improving the collection and reporting of adverse reaction data. The ADR system has been enhanced, Lerner said, through the "enormous improvement in what I would call the technical aspects of data gathering -- the computer links, reports, and so on." Asked about the use of electronic data submission for NDAs, Lerner pointed out that people will have to adapt to the use of computers as a new tool. The Roche exec commented that one obstacle in assuring proper use of electronic NDAs will be "to get people to understand that you use the computer for evaluation and presentation of data that you can analyze. You should not use the monitors or computers to read what you used to read in the printed form." Lerner said, "that's a hurdle that people have to get over over time." Lerner explained that the "real challenge" will be "to make the mechanism produce a more expedited, more careful review of the data by using the technology to analyze, evaluate, and kick-out exceptions." That is, he said, to "apply the [computer] talent to evaluation, not to the mundane reading of a lot of verbiage that may not be essential." At FDLI, FDA Office of Drug Research & Review Director Robert Temple pointed out that the agency's Cardio-Renal review division has "finished, up to the point of completing the supervisory reviews" on the two electronic NDA pilot projects. Abbott submitted electronic versions of NDAs for Cartrol and Vasocard with that division. Temple said that based on its initial experiences, the agency is cautiously optimistic about electronic transfer of some NDA data. He said the agency had reached two general conclusions from the early experience: (1) that analysis is still "unavoidable"; and (2) that case report forms and tabulations can be put in forms that are easily usable by FDA reveiwers. "Finding given pieces of data," Temple noted, "is pretty easy with the system we used." Collating that information and "looking at relationships is much harder and you need a lot of help." Temple maintained that it is "impossible for us to say whether this speeds or doesn't speed the review." He said his impression is that "to some extent in the long-run" it will speed up reviews by allowing FDAer to answer a number of questions during reviews on their own. Temple noted that the electronic access to data in NDA reviews can also create a tendency to "browse" through information and may raise more questions for the reviewer thus slowing the review. However, the ability to find answers to questions without having to ask the sponsor for another submission outweighs the browsing tendency, Temple said. "We're eager," Temple added, "for people who want to try it to make their approach to the division, try to get in touch with the particular reviewer and the supervisors of that division and do more of these [test projects]." Temple said that FDA is still open to a wide range of electronic forms of NDA information submission. "At this stage," he said, "we are willing to try anything -- different software, different approaches."
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