FDA is proposing a regulation to allow it to destroy a drug valued at $2,500 or less, or higher amounts as may be set by regulation by the US Secretary of the Treasury, which has been refused admission into the United States by providing to the owner or consignee notice and an opportunity to appear and introduce testimony to the agency prior to the destruction. Currently, regulations provide the owner or consignee of an FDA-regulated product offered for import into the United States with notice and opportunity to present testimony to the agency prior to refusal of admission of the product. The proposed rule would expand the scope of the regulations to provide an owner or consignee with notice and opportunity to present testimony to the agency prior to the destruction of certain refused drugs.
The proposed regulation is authorized by amendments made to the Federal Food, Drug, and Cosmetic Act and by the Food and Drug
Administration Safety and Innovation Act (FDASIA). The majority of refused drug products subject to FDA's new destruction authority come into the United States via an International Mail Facility (IMF) or an express courier hub. Parcels that come into the United States via an IMF are routed by the United States Postal Service (USPS) to Customs and Border Protection (CBP). CBP interdicts certain drug shipments and turns them over to FDA for examination and a determination of admission. Some of these parcels may include one or more drugs that are unapproved, adulterated, and/or misbranded, including counterfeit drugs and drugs that purport to be dietary supplements. USPS estimated that the average daily number of parcels that came into the United States via international mail from November 1, 2011, to October 31, 2012, was nearly 1.2 million and that the number of such parcels that contain drugs that enter the United States each year through the IMFs is between 20 million and 100 million.
Drugs that are imported via an IMF that are refused are sent back to the USPS for export. "There is currently little deterrence to prevent sellers from sending violative drugs or resending previously refused drugs into the United States via the IMFs" said FDA in its proposed rule. "Drugs refused admission into the United States might be subsequently offered for re-importation by unscrupulous sellers who choose to circumvent the import regulatory systems. In fact, some of the parcels returned by USPS have been resubmitted for entry into the United States by the sender, with the sticker indicating prior refusal by FDA still attached and visible." Under this proposed rule, FDA will be better able to prevent such re-importation by having an administrative mechanism for destroying a drug valued at $2,500 or less, or higher amounts as may be set by regulation by the US Secretary of the Treasury, which has been refused admission.
FDA has issued several warnings about counterfeit and unapproved drugs, including warnings issued in 2012 and 2013 about counterfeit versions of the cancer medicines Avastin/Altuzan (bevacizumab) approved for marketing outside of the United States, which were purchased by medical practices in the United States.Certain counterfeit versions of these drugs did not contain the active pharmaceutical ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy. In July 2013, a British citizen was sentenced to 18 months in prison for distributing adulterated cancer drugs and selling a counterfeit version of Altuzan that was obtained from Turkey to physicians in the United States. As of December 2013, FDA has issued over 1500 letters to medical practices in the United States to educate them about risky buying practices and to warn them about counterfeit and unapproved drugs in US distribution.
"Once finalized, this proposed regulation will allow FDA to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain," said FDA in the proposed rule. Public comment for the proposed rule is open until July 7, 2014.