Posted 14 September 2015
By Zachary Brennan
As part of its efforts to protect the drug supply chain, the US Food and Drug Administration (FDA) is implementing a final rule that will allow it to destroy a drug valued at $2,500 or less that has been refused entry into the US under federal law.
The final rule -- which is authorized by amendments made to the Federal Food, Drug and Cosmetic Act by the Food and Drug Administration Safety and Innovation Act (FDASIA) -- comes as under existing rules, even if a misbranded or counterfeit drug is detained at the point of import, its sponsor can apply to have the drug returned to him/her within 90 days, preventing FDA from destroying it.
That sponsor can then re-send the rejected drug to the US for import, raising the chances that it will slip past inspectors.
FDA previously said that between 20 and 100 million parcels imported into the US each year contain drugs, most of which originate from Internet pharmacies of questionable repute.
Under the final rule, owners or consignees of the shipments will still have the same options for submitting testimony in opposition to the destruction of their drugs.
And furthermore, FDA says it anticipates that owners or consignees will still have the option to destroy or export a refused drug in at least two situations.
First, owners or consignees of a drug valued over the current $2,500 threshold that has been refused admission will still have the option to destroy or export that drug unless the drug has been imported via an International Mail Facility (IMF).
But for a drug valued at $2,500 or less that has been refused admission, FDA is allowed to destroy the drug without providing the owner or consignee with the opportunity to destroy or export it.
The second situation where owners or consignees will still have the option to destroy or export a refused drug is when FDA refuses admission to a drug, including a biologic, but the agency is not able to determine that the drug is adulterated, misbranded, or unapproved.
Ultimately, the agency believes the rule will provide a disincentive for companies to import drugs that are adulterated, misbranded, or unapproved.
FDA says it's preparing for about 15,100 destructions annually, though the agency is less clear on how much the final rule will cost and/or save it, noting that FDA estimates the quantifiable net annual effect of the final rule to range between a cost of $54,325 and a cost savings of $901,950.
The agency also said the final rule will incur one-time costs of $531,670, which will be connected with updating the FDA Operational and Administrative System for Import Support (OASIS), making appropriate revisions to Chapter 9 of the FDA Regulatory Procedures Manual (RPM) and the agency’s internal import operations guidelines, and training for FDA personnel.
FDA says it received 22 comments on the proposed rule, though it is not making any changes on the regulatory language between the proposed rule and the final rule. The final rule takes effect in 30 days.