When a government agency makes mistakes when doing a prescribed task, should Congress insist that it improve its performance, or simply tell it to dismiss the task altogether? When it comes to the FDA’s Office of Criminal Investigation (OCI), we may soon find out.
Reuters recently published an expose claiming that OCI is misguided in performing one of its key functions: investigating the criminal importation of drugs produced abroad. According to the report, OCI often fails to get the correct search warrants when seizing potentially illegal drugs, and evidence collected by OCI is routinely deemed inadmissible in court. It tends to run roughshod over the rights of the accused, and generally does a ham-handed job prosecuting those it accuses of committing drug-related crimes: Reuters reports that OCI has considerably less success in attaining indictments for its investigations than its counterpart offices in the EPA and other federal agencies.
The House Energy and Commerce Committee was understandably indignant over the Reuters investigation’s findings, and responded with a letter to the FDA suggesting that it cease prosecuting drug reimportation cases. However, this is a nonsensical response to OCI’s failings, akin to suggesting that firefighters stop putting out flames due to bureaucratic glitches at the firehouse.
The potential danger of unregulated drug reimportation without tangible enforcement action is real: few other countries have the strict protocols that exist in the U.S. (which are overseen by the FDA) to ensure that a drug contains precisely what it is supposed to have and that there has been no adulteration or spoilage along the way.
For drugs produced overseas that have not gone through this protocol, no such assurance can be given. While it may very well be true that the vast majority of these drugs are perfectly safe, it is also a fact that counterfeit drugs are a dire problem across the globe, and countries have found it difficult to deter such counterfeiting. U.S. embassy employees in China are instructed upon arriving in the country to obtain all their drugs, prescription or otherwise, from the pharmacy maintained in the embassy itself rather than trust the vagaries of the country’s market.
Some time ago, Congress contemplated creating new pathways for the re-importation of certain drugs, and it declined to do so–largely because of the safety issue. For a committee chair to blithely suggest that we cease enforcing this existing law is a non-legislative usurpation of an explicit congressional decision.
To be sure, OCI’s performance has left much to be desired, and Congress should be investigating its actions on this issue, but it’s worth noting that OCI’s task is not an easy one. It can be difficult to identify the differences between U.S.-made and FDA-approved drugs, U.S.-made drugs packaged for export, foreign-made drugs that are not permitted to be sold in the country, and counterfeit drugs. This confusion has led to an over-zealous OCI attempting to score quick convictions frequently trampling on the rights of doctors who thought they were acting correctly.
But drug safety is important to U.S. consumers, and to suggest that it’s not worthwhile for the FDA to concern itself with the importation of drugs that do not go through any sort of certification to verify that they are safe would be an abdication of duty. It would only be a matter of time before someone became sick as a result.
The Reuters investigation quoted disgruntled OCI employees who felt that their task was to prevent doctors from buying cheap foreign knock-offs, specifically of Botox drugs. While it may be impossible for anyone to evince sympathy for drug company profits, it’s worth noting that Botox involves injecting a live toxin into someone’s face, and that Botox drugs must be refrigerated at all times in order to preserve safety and efficacy—not the easiest thing to accomplish for an item being shipped halfway around the world and sold by an operator of dubious legality. And it’s important to note that Botox is not just a cosmetic drug—it’s used for a wide variety of therapeutic purposes, including treatment of migraines, bladder issues and Multiple Sclerosis.
Congress would be better served to encourage OCI to be more judicious in determining which investigations it conducts, as well as to conduct itself in a more professional manner. For example, establishing a system of oversight to ensure OCI obtains proper search warrants and resists the lure of high-profile yet relatively unproductive crackdowns.
If the next Congress wants to reopen the issue of drug re-importation, it is certainly its prerogative to do so. But until it does—and sets up new protocols for ensuring safety in such a regime—it is a legitimate and necessary task for the FDA’s Office of Criminal Investigation to ensure that the drugs sold in this country are unadulterated and safe for consumption. And for now at least, that necessitates them having been produced in this country.
Ike Brannon is president of Capital Policy Analytics, a consulting firm in Washington.
