A proposed amendment to the Food and Drug Administration Safety and Innovation Act (FDASIA) will allow confiscation of personally imported medicines (defined as worth under $2,500 (€1,800)) which fall foul of the US Food and Drugs Administration (FDA)’s approved drugs list.
Rejected products can include counterfeit medicines and those obtained from “rogue” pharmacies without a prescription.
‘Refusal sticker still attached’
PhRMA has called for implementation of Section 708 of FDASIA, saying the criteria for destroying seized medicines are “time-consuming and costly.” The result, said the organization, is that packages are usually returned to the sender and can then be resubmitted many times over, hoping to slip through the cracks at Customs and Border Protection.
The pharmaceutical industry group said it is particularly concerning that under the existing system, “there is little deterrence to prevent sellers from sending violative drugs or resending previously refused drugs into the United States.”
PhRMA added that: "Some parcels exported and returned to the sender have been resubmitted for entry into the U.S. by the sender with the sticker indicating prior refusal by FDA still attached and visible on the parcel.”
It said the proposed the proposed rule, allowing the impounding of illegal drugs, is necessary to preventing counterfeits entering the US and saving FDA resources for other important activities.
‘Canadian’ drugs from Vanuatu
But critics of the amendment say not all drugs refused by US Customs are dangerous. PharmacyChecker’s Gabriel Levitt told us some items are seized at the border because they are packaged for a different country, but the medicines themselves may be functionally identical to ones approved and sold inside the US.
PhRMA responded to these claims, telling in-Pharmatechnologist.com it is vital to maintain the US’s “closed” drug distribution system, and to keep the FDA in control of the manufacture, labelling and distribution of prescription medicines.
“The problem with allowing importation from even a subset of countries is that these countries have no obligation to ensure the quality and safety of medicines that are shipped for export to the US,” said a spokesman. “For example, Health Canada officials have stated that ‘Health Canada does not assure that products being sold to US citizens are safe, effective, and of high quality, and does not intend to do so in the future.’
“As a result, there is no guaranteeing that a patient will actually receive a medicine that has been reviewed and approved by the health regulators in a specific country; the product could have just been shipped through the country and originated elsewhere. For example, FDA investigation found that 85 percent of the drugs being promoted as ‘Canadian’ actually came from 27 other countries around the globe, including India, Costa Rica and Vanuatu.”
PhRMA referred to a report by the National Association of Boards of Pharmacy (NABP) which reviewed 8,300 online pharmacies in 2011 and found 97% were “rogue” operations:
“In other words, even if a law only allowed importation of prescription drugs purported to have the same active ingredients, route of administration, and strength as a prescription drug approved by the FDA, there is no comprehensive oversight mechanism to ensure that is actually the case. Thus many proposed importation bills would encourage patients to transfer their source of prescription drugs from safe, regulated domestic pharmacies and to unsafe, unreliable, and unregulated foreign mail-order pharmacies.”
“What FDA would be destroying at the border are not products that are essentially ‘identical’ to FDA-approved products, but rather […] products whose true origin is highly uncertain and are likely mislabeled, adulterated, or counterfeit.”
PhRMA suggested that instead of buying drugs from abroad, US patients trying to save money should look for generic versions available in the US, especially through cost-saving pharmacy chain programmes.