In their continued efforts to protect us from the dangers of unauthorized drugs, the FDA now has the authority to destroy suspicious shipments, at their discretion, without notifying the shipper. First proposed last year, the Food and Drug Administration Safety and Innovation Act (FDASIA) amendment replaces the previous requirement to return refused drugs to the shipper. They now intend to “better protect the public health by [allowing] for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain.” Once destroyed, the drugs can no longer be re-shipped in the hope that the products will slip past inspectors and make their way to consumers.
The impact could be significant.
One in six Americans has ordered prescription drugs online, and the FDA estimates that between 20 and 100 million parcels imported into the US each year contain drugs, many from unauthorized online pharmacies. Most of these small-value parcels are entering the country through the mail where they are screened by Customs. The FDA anticipates destroying over 15,000 parcels per year – but with total shipments in the millions, it may well be considerably more.
Not only will the new rule have a clear public health benefit, but as the FDA notes, it also “may benefit firms through increases in sales, brand value and investment in research and development if the destroyed drug is … [a] falsified version of an approved drug… [and] may also have a deterrent effect.” Pharmaceutical companies may well realize additional revenue as more “adulterated, unapproved or misbranded” versions of their drugs obtained online are blocked at the border. Brand protection strategies may get a little easier with fewer rogue pharmacies successfully getting their product to consumers.
This development further underscores the need for pharmaceutical companies to maintain a robust and comprehensive brand protection program. Because these parcels are suspected counterfeit, their destruction triggers an administrative notice to the brand owners and an authenticity check. This intelligence should be captured and analyzed in conjunction with other data sources to target and compile evidence against key infringers with even greater accuracy – for example identification of repeat offenders, shipments going to the same address but varying recipient name, or incongruous shipping patterns.
While defensive online detection and enforcement of these suspicious sites are crucial, on their own they will not give complete visibility into the scope of the problem or uncover networks of abuse. But a program that bridges online enforcement and physical investigation, including connections with law enforcement and government agencies, enable the pharmaceutical brand owner to target and take down the worst offenders. With end-to-end visibility into the problem as well as key resources to effectively combat it, both valuable pharma IP and patient health are protected.
Ideally, with consumers increasingly deterred from knowingly or unknowingly ordering drugs from unauthorized Internet pharmacies, they will seek out legitimate channels to ensure they receive the medication for which they are paying – and that is better for everyone.