This summer we’ve been bombarded with reports of terrorist threats to U.S. financial institutions, political conventions, transportation means, and other targets. So the report last week that the nation’s drug supply is also at risk likely surprised few.

According to CNN, FDA’s acting commissioner Lester M. Crawford fears that terrorists might be eyeing food and drug products as potential targets. When asked to elaborate by PMP News, FDA declined to say anything more, including whether the agency had been briefed about a specific threat.

But FDA isn’t sounding the alarm without reason. In a June 2004 speech before the Association of Food and Drug Officials, Crawford explained that the food supply “has been widely recognized as a potential terrorist target” because it is “a life-sustaining, universally consumed commodity” and is “susceptible to contamination.” Couldn’t those terms also describe our drug supply?

Peter Mayberry, executive director of the Healthcare Compliance Packaging Council, feels that Crawford’s concern is a legitimate one that deserves national attention. “To me, Dr. Crawford’s statement is a wake up call regarding the security of our nation’s pharmaceutical supply. Putting the debate about imports aside, consider that U.S. pharmaceuticals are almost always shipped from the manufacturer in bulk containers and routinely change hands several times before being dispensed to patients. Dr. Crawford’s comments suggest, therefore, that our distribution system may not protect against the wide-scale introduction of contaminated pharmaceuticals by a terrorist entity.”

So why not urge the pharmaceutical industry to abandon its current method of turning bulk drug shipments loose in the distribution chain? Dispensing prescription drugs in secure, tamper-evident unit-of-use packages that became the standard after the Tylenol poisonings, which Crawford alludes to in the CNN report, will make it harder for terrorists to pull off such an attack. FDA has already endorsed bar codes to control drug administration errors in hospitals and track-and-trace methods to combat counterfeit drugs. Why not take the next logical step, as we argued earlier this year and ask for unit-of-use packaging? (Mayberry, too, argues this point in the September 2004 issue of Unit Dose Alert).

FDA and the Department of Health and Human Services may just have the authority to do so. In May the Senate passed Bioshield, which will secure drugs needed to respond to a terrorist attack. The bill also authorizes the HHS secretary to take necessary qualified countermeasures to ensure that drugs, biological products, and devices are protected so that the secretary can “prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security . . . or . . . prevent harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device.”

Calling tamper-evident unit-of-use packaging a countermeasure may be stretching the bill’s reach. But bulk drug distribution has been shown to be vulnerable to counterfeiting and diversion. Terrorist tampering, sadly, seems just as likely. Why wait to respond to an attack?