By: Howard Sklamberg and Melinda K. Plaisier
Recently, FDA published the final rule implementing section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA). This new rule, which will take effect on October 15, 2015, provides FDA with an administrative process for the destruction of certain drugs refused admission to the United States. Why is this important? These drugs can pose a serious public health risk to consumers in the United States.
On July 9, 2012, President Obama signed FDASIA into law. Title VII of FDASIA provides FDA with important new tools to help the agency better protect the integrity of the drug supply chain. One of those new tools is in section 708, which grants FDA the authority to use an administrative procedure to destroy a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that was refused admission into the United States.
The majority of refused drug products subject to FDA’s new destruction authority come into the United States via international mail. Some of these mail 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.
These drugs can pose a serious public health threat to consumers in the United States because they:
- might not contain the active ingredient that patients need for treatment of their disease;
- might have too much or too little of an active ingredient;
- might contain the wrong active ingredient; and/or
- might contain toxic ingredients.
In addition, drugs that are represented and sold as dietary supplements can contain hidden or deceptively labeled active pharmaceutical ingredients, some at levels much higher than those found in FDA-approved drugs. Such products can cause harm and have been associated with serious adverse events for consumers. Other purported dietary supplements, although they may not contain harmful ingredients, are promoted to prevent or treat serious diseases but have not been proven safe and effective for that purpose.
Prior to this rule, drugs imported via an International Mail Facility (IMF) that were refused admission because they appeared to violate the law were generally sent back to the U.S. Postal Service (USPS) for export. There has been little deterrence to prevent sellers from sending drugs that violate the law or resending previously refused drugs into the United States via the IMFs to circumvent import regulatory systems.
In fact, some of the parcels returned by USPS were resubmitted for entry into the United States by the sender, with the sticker indicating prior refusal by FDA still attached and visible. This new rule allows FDA to better deter such importation by having an administrative process in place to destroy a refused drug. Rather than returning the drugs to the sender, these drugs will be destroyed. Compared to the volume of entries at IMFs, the agency has limited on-site resources. By deterring violative imports and re-entry attempts, this new process will allow the agency to more effectively focus its limited resources.
Under the final rule, FDA will provide the owner or consignee of the refused drug with written notice and an opportunity to appear and introduce testimony to the agency prior to the destruction. If the drug is destroyed, section 708 provides that the owner or consignee is responsible for the costs of storage and disposal of the drug. However, FDA generally does not intend to pursue recovery of storage and disposal costs against individual consumers who seek to import a drug for their own personal use that is then refused and destroyed.
By enabling FDA to destroy certain drugs, this important action will allow FDA to continue to protect and promote public health.
You can look up the current status of any FDASIA deliverable and sign up to receive Title VII updates using FDASIA-TRACK.
Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.
Melinda K. Plaisier is FDA’s Associate Commissioner for Regulatory Affairs.