Initiator: Leroy Presley
Participants: Andrew Draybuck
Discussions Highlights:
Pharmaceutical and medical device companies do not have enough of an incentive to incorporate tamper evident measures. The companies are willing to pay off a plaintiff or endure the loss profit from counterfeiters rather than pay extra for active and intelligent packaging.
Pharmaceutical companies are paying several million dollars to certify a drug for market use. If the drug fails at phase two and they reformulate it, they must pay to start the process over again. If the FDA reduces the cost, pharma companies can push any item to the market without it being safe. At the current stage, the pharma companies are losing money when they are bringing a product to market, which is why a price increase is justifiable. The FDA cannot dictate the price of a product and pharma companies think first about their bottom line.
UDI is a example to get companies to comply-companies are forced to adhere to the Global UDI standards as well as the standards of each country. Since the compliance is still unclear, the company will not comply until the process is clear.
Next Steps or Ideas for Action:
Unless there is a catastrophic event causing significant losses to pharma company losses, there is no changes in sight.
Participants: Andrew Draybuck
Discussions Highlights:
Pharmaceutical and medical device companies do not have enough of an incentive to incorporate tamper evident measures. The companies are willing to pay off a plaintiff or endure the loss profit from counterfeiters rather than pay extra for active and intelligent packaging.
Pharmaceutical companies are paying several million dollars to certify a drug for market use. If the drug fails at phase two and they reformulate it, they must pay to start the process over again. If the FDA reduces the cost, pharma companies can push any item to the market without it being safe. At the current stage, the pharma companies are losing money when they are bringing a product to market, which is why a price increase is justifiable. The FDA cannot dictate the price of a product and pharma companies think first about their bottom line.
UDI is a example to get companies to comply-companies are forced to adhere to the Global UDI standards as well as the standards of each country. Since the compliance is still unclear, the company will not comply until the process is clear.
Next Steps or Ideas for Action:
Unless there is a catastrophic event causing significant losses to pharma company losses, there is no changes in sight.