The safety and authenticity of these pharmaceuticals should be assured at each point along the stream of commerce. Regular inspection of the flow of prescription drugs from the point of manufacture to the ultimate point of dispensing is necessary. FDA should implement mechanisms by which foreign pharmacies and wholesalers can be registered with and licensed by, or on behalf of the FDA. These entities should be fully accredited and licensed by a reputable licensing board.
Consumers should be made aware of the results of FDA plant inspections and licensing activities. For example, FDA could provide electronic links from its Internet site to approved Internet pharmacies in Canada and other countries as appropriate. Having the FDA web site as the point of contact for a list of approved pharmacies would provide consumers with an official, secure source of information on safe drugs. However, not all consumers have access to the Internet; therefore, there should be mechanisms in place that will allow consumers to call a toll free number sponsored by the FDA, or other appropriate entities, in order to get information on approved foreign sources from which consumers can purchase lower cost pharmaceuticals. Consumers should also have confidence in the Internet sites they use to purchase drugs from other countries. We recommend that a system be put in place to identify and shut down unregistered Internet pharmacies.
One way of effectively ensuring the safety of pharmaceuticals is the institution of pedigree requirements – being able to trace a drug from the point of origin to the point of dispensing. In order to accomplish this task in an expanded international arena, there should be a way to trace pharmaceuticals back to the point of manufacture and enforce pedigree requirements. Each entity that handles prescription drugs should be required to maintain records as to the drug's pedigree. Furthermore, there should be no impediments to an entity's ability to receive records regarding a drug's pedigree.
Pharmaceuticals imported from another country should be equipped with anti-tampering materials and anti-counterfeiting measures. As the technology in this area progresses, imported pharmaceuticals should be equipped with state of the art devices, such as bar codes, and specialized ink, or other appropriate technology. We urge the Committee to work with the FDA and others with the expertise necessary to determine appropriate anti-tampering and anti-counterfeiting requirements.
Other measures aimed at counterfeiting and tampering to be considered include the prohibition on repackaging and re-labeling of pharmaceuticals from other countries. This requirement could be enforced through the pedigree standards. Repackaging and re-labeling of pharmaceuticals creates the potential for misbranded or counterfeit drugs to enter the stream of commerce. Imported pharmaceuticals should be shipped in a manner that provides a tracking number (e.g., via international mail systems or some similar entity) to reduce the opportunity for counterfeit pharmaceuticals to enter the stream of commerce from outside the point of manufacture.
Because pharmaceuticals may be manufactured in countries where English may not be the official language, pharmaceutical labels and patient package inserts destined for the United States should be written in English as well. These labels should be applied at the point of manufacture, or prior to entry into the United States. Imported pharmaceuticals should be labeled in such a way as to indicate to the consumer that the drug has been imported under the new law.