After receiving a Warning Letter from OPDP regarding a questionable claim, a pharmaceutical company was tasked with recalling every marketing item containing the claim from the field. Because some of the marketing pieces had been sent directly to HCPs, they also needed to identify who received the pieces in the mail so any corrective actions could be subsequently sent.
Day Zero. Within minutes of receiving the warning letter, their marcomCORE site was shut down so no new orders could be placed, any orders already queued would be halted, and all shipping of materials was stopped. Inventory reports were run identifying all materials in the field.
Day One. While the pharmaceutical company's legal department worked with OPDP, marcomCORE sent out shipping labels to all representatives so materials could be returned directly to their warehouse for a final inventory audit and certification of destruction. Any materials currently in inventory at marcomCORE's warehouse were audited and sent to the quarantine area of the warehouse where they were held for final destruction.
Days Two through Seven. Materials were being received at the warehouse from the field during this time. Each box was counted, recorded and put in quarantine.
Day Eight. All materials were returned from the field. Reports were run and verified in anticipation of their submission to OPDP.
Days Nine through Thirty. During this time, marcomCORE's creative department made the necessary corrections to the marketing materials and created the new files for printing. Regulatory print samples of the new materials were created and sent to the pharmaceutical company for their prior approval submission to OPDP. Also during this time, all materials were destroyed and certificates of destruction were issued.
Once OPDP had approved the new marketing materials, marcomCORE printed them, created the inventory files and uploaded the new items onto the company's site, and shipped a one time customized bulk shipment to all field representatives.
Needless to say, our clients were very pleased with the efficiency of marcomCORE and how it helped to get the required information to OPDP quickly allowing them to get back into business.
If it had not been for the marcomCORE program and the personalized attention by marcomCORE's customer service team, we never would have been able to have our sales force back in the field selling within 60 days of receiving the warning letter. That has to be a record.
Adriann Sax
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