FDA Proposes New Regulation to Secure the U.S. Pharmaceutical Supply Chain

The Food and Drug Administration has proposed a regulation aimed at keeping counterfeit, unapproved and adulterated pharmaceuticals out of the U.S. drug supply chain.

The new rule would allow the agency to destroy a drug valued at $2,500 or less that has been refused admission into the U.S. Owners of the products would receive notice and have an opportunity to submit testimony to the agency before a drug is destroyed.

The public has until July 7 to comment on the proposed rule.

“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 says in a summary of the rule, which it proposed on May 6.

“Violative drugs pose a serious public health threat to consumers in the United States because they might not contain the active ingredient that patients need for the treatment of their disease; they might have too much or too little of an active ingredient; they might contain the wrong active ingredient; and/or they might contain toxic ingredients,” the FDA says.

“By taking these drugs, consumers may be harmed directly by exposure to unsafe drugs or they may be harmed because they are prevented from getting the appropriate dose or strength of medications they need. Adverse events due to these violative drugs are underreported. Patients taking ineffective drugs may die or suffer the adverse effects of the underlying disease, making it difficult to detect or attribute these consequences to the violative drug,” the agency explains.

In 2012 and 2013, the FDA issued warnings about counterfeit versions of the cancer medicines Avastin and Altuzan (bevacizumab) approved for marketing outside of the United States, that were purchased by U.S. medical practices. Certain counterfeit versions of these drugs did not contain the active pharmaceutical ingredient, which may have resulted in patients not receiving needed therapy, the FDA says.

In many cases, U.S. consumers purchase disallowed drugs over the Internet, the agency notes. Rogue Internet pharmacies operate Web sites that may look professional and legitimate, but really often sell unapproved, adulterated or misbranded drugs, the FDA says.

A 2013 government report determined there were more than 34,000 active rogue Internet pharmacies, notes the FDA, which says it has received several reports of adverse events related to drugs purchased from such operations. In at least some of those cases, the patients required emergency medical treatment for the drug-related reactions.

This proposed regulation is the latest government move to secure the pharmaceutical supply chain. Late last year, President Obama signed the Drug Quality and Security Act, which, as Gartner notes, requires the FDA to set standards for tracking and tracing medicines. The new law gives the FDA authority to oversee all points in U.S. pharmaceutical supply chains and phases in requirements for drug manufacturers.