Under the proposed regulation, the scope of the FDA’s authority would be expanded to destroy refused drugs after the owner or consignee of the drug is provided with an opportunity to present testimony prior to the drug’s destruction. Currently, the owner of the drug can provide testimony prior to the refusal of admission of the product.
The FDA estimates it will contract out about 12,100 drug destructions each year, which would mean the quantifiable net annual social benefit of the proposed rule, if finalized, would be between $228,000 and $618,000.
“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,” the agency notes.
The estimated primary costs of the proposed rule, if finalized, include the additional costs to destroy a drug that is in violation of the Food Drugs & Cosmetics Act.
The agency notes that the majority of refused drug products subject to FDA's new destruction authority come into the US via an International Mail Facility or an express courier hub. These parcels are often routed by the United States Postal Service (USPS) to Customs and Border Protection, which turns them over to FDA for examination and a determination of admission.
USPS estimated that the average daily number of parcels that came into the US via international mail from November 1, 2011, to October 31, 2012, was nearly 1.2m, although the FDA was only able to evaluate a fraction of those.
From FY 2010 through 2012, FDA examined nearly 45,000 shipments and CBP seized more than 14,000 illicit shipments of prescription drugs.
The FDA notes that it has issued several warnings about counterfeit and unapproved drugs in 2012 and 2013 for the cancer medicines Avastin and Altuzan that were purchased by medical practices in the United States. Certain counterfeit versions of these drugs did not contain the active pharmaceutical ingredient. Last July, a British citizen was sentenced to 18 months in prison for distributing adulterated cancer drugs and selling a counterfeit version of Altuzan.
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.
Companies can submit either electronic or written comments on the proposed rule by July 7.