FDA had planned to give higher priority to enforcing pedigree requirements for prescription drugs that face the greatest risk of diversion and counterfeiting. Despite the rule’s delay, manufacturers may still want to work toward some sort of pedigree. If you can answer yes to any of these questions posed by FDA, your product may face a high enough risk to warrant pedigrees immediately:
• Does the drug product have a high sales volume or price in the United States?
• Is the drug product a “high priced/specialty” product used for a serious or life-threatening disease?
• Is the drug in high demand?
• Is there a shortage of the drug?
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• Are there prior cases of the drug being counterfeited or diverted in the United States? Is there a history of false pedigrees associated with the product?
• Is there a reasonable probability that the drug may be counterfeited or diverted based on the above questions?
• Does the drug have priority review status?
• Based on drug products that are in a similar drug class, is the drug predicted to have a high potential market size and value?