A group of pharmaceutical vendors developed a system for filing reports to the FDA without receiving any FDA funds.
A group of pharmaceutical vendors has developed what might best be described as an e-government system, although it did not use any government funding.
The FDA Incident Reporting System will enable pharmaceutical vendors to file electronic reports with the Food and Drug Administration on loss, theft and similar problems with drug samples, as required by the Prescription Drug Marketing Act (PDMA) of 1987.
The alliance had input from the FDA on this project, but the industry group developed it without any FDA resources, said Steve Haynes, director and government liaison of the PDMA Alliance.
The value of such a system "is not something that was lost on the FDA," Haynes said. It had an interest in electronic filing "but…really didn't have the funds to do it."
Industry vendors, though, had the money and decided it was worth their investment.
One reason was the convenience of filing reports electronically. But the alliance did more than build an e-filing system. The pharmaceutical vendors also agreed on the standard elements that the incident reports should include. Until now, individual vendors had independently decided what to include in such reports.
They were able to find an approach that gives the FDA the information it needs about drug sample incidents without the report becoming overly burdensome for industry.
The alliance had approached the agency at the outset and described what it wanted to do, then touched base with the FDA throughout the development, Haynes said. ''We did it on our own initiative, but kept them in the loop," he said.
The system was developed at no cost by two main vendors: Synergistix, which makes sales force automation and customer relationship management software, and CSSC, a consulting company specializing in regulatory compliance and validation.
The agency cannot officially endorse the use of the incident reporting system because other industry groups could develop their own solutions. But the agency has sent a letter to the alliance supporting this type of reporting format, Haynes said.
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