Did legislators go far enough in their attempts to secure the pharmaceutical supply chain when passing the Drug Quality and Security Act (DQSA) last year?

That question is now on the minds of some after pharmaceutical manufacturer GlaxoSmithKline issued a massive recall of all lots of its over-the-counter weight loss drug Alli (orlistat capsules) following a determination that some lots of the drug had been "tampered with."

While the DQSA contains extensive requirements intended to protect the pharmaceutical supply chain through the formation of a national "track and trace" system, a careful reading of the law finds that even if its provisions had gone into effect immediately, it would not have been able to aid regulators in tracking down the source of tampering.

Background

The DQSA was passed in November 2013, in part due to concerns about drug counterfeiters, and the desire of regulators to be able to determine at which point in the supply chain counterfeit drugs had been introduced.

One of that law's major provisions, known as the Drug Supply Chain Security Act (DSCSA), contains extensive requirements related to a nationwide pharmaceutical "track and trace" system.

Track and trace is intended to be a system in which a drug can be "tracked" from a manufacturer to its end user (forward through the supply chain) or "traced" from an end user back to its point of origination (backward through the supply chain).

The DSCSA establishes a system in which all prescription drug packages will need to carry a serial number (reflecting the manufacturing lot) within four years, with unit-level (i.e. package) numbering coming into effect 10 years thereafter.

That number and other information would be recorded each time a drug was passed through the pharmaceutical supply chain, such as from a drug manufacturer to a wholesaler or a wholesaler to a retailer. If a counterfeit medicine was introduced into the supply chain, it would therefore be easier to determine its point of entry by examining the records of each entity.

Prescription Drug

But the key term found throughout the DQSA is "prescription drugs." In other words, only drugs required by prescription need to comply with the terms of the DQSA.

The law defines prescription drug as "a drug for human use subject to section 503(b)(1)" of the Federal Food, Drug and Cosmetic Act (FD&C Act).

Section 503(b)(1) defines prescription drug as:

A drug intended for use by man which-

(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or

(B) is limited by an approved application under section 355 of this title to use under the professional supervision of a practitioner licensed by law to administer such drug;

shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.

OTCs: Not Covered

But Alli, as an OTC drug, is not required to comply with the DQSA once it comes into effect in 2017. Since it's not a prescription drug, the DQSA's definitionsdon't apply.

And Alli isn't the only OTC medicine that could be at risk for copycat or counterfeit behavior. According to the Consumer Healthcare Products Association (CHPA), a trade group representing OTC manufacturers, more than 240 million US consumers use OTC medicines, spending more than $23 billion on them in 2010.

In other words, that's more than $23 billion in pharmaceutical products that won't benefit from the DQSA, and 240 million Americans who could be at risk.

It's not the first time OTC products have been targeted-the 1982 cases of Tylenol poisonings are a classic example-and it likely won't be the last time, either.

Whether legislators will consider the case problematic enough to take action, though, remains to be seen.