Counterfeits Continue to Plague Patients
FDA reports that federal agencies have come across contaminated, counterfeit, and subpotent influenza products. “FDA, with U.S. Customs and Border Protection, has intercepted products claimed to be generic versions of the influenza drug Tamiflu, but which actually contained vitamin C and other substances not shown to be effective in treating or preventing influenza,” the agency reports.
Such news shows that counterfeiting is often a crime of opportunity. If products are in great demand, of high value, and in short supply, as H1N1-treating products were a few months ago, counterfeiters will attempt to meet that demand.
FDA likely hasn’t seen the last of the counterfeit influenza products, given the rather unique influenza season approaching against a backdrop of economic instability and high unemployment. Patients will be fearful, and many of them will be looking for low-cost solutions.
And if certain products are indeed in short supply, as some fear the H1N1 vaccines will be, could doctors desperate to help patients look for alternate supply sources outside established channels?
It is certainly possible.
Expect FDA to step up its patrols along with other federal agencies, however, especially if the H1N1 pandemic hits the United States hard. At a Food and Drug Law Institute (FDLI) meeting August 6, FDA commissioner Margaret Hamburg said that the agency is focusing on “effective enforcement against violations of the law.” She did not mention counterfeit or diverted products, but clearly such adulterated products do violate FDA regulations.
“Effective enforcement has many clear benefits to public health. It enables FDA to intercept unsafe or fraudulent products promptly . . . and prevent additional harm,” she said. “By holding violators accountable, enforcement deters others who would put the public at risk or prey upon vulnerable consumers.”
I hope this means that FDA will make counterfeit busts more public. “Visible and clearly explained enforcement actions inform members of the public about potential dangers,” Hamburg said.
Such visibility could make both patients and practitioners aware of the risks associated with unlicensed Internet pharmacies or unauthorized distributors, respectively.
Hamburg spoke of another goal, one that I believe could encourage pharmaceutical and medical device companies to implement technology that discourages counterfeiting and diversion. “Our goal is for all companies to make and implement such a commitment in order to prevent harm to the American people,” she said.
In this issue of Tracking & Tracing Pharmaceutical Products, we include reports on the latest technologies for identifying and authenticating your products. Some companies suggest the use of bar coded item-level serialization to provide the means for unit identification. Others suggest proprietary physical markers for unit authentication. And there are even more approaches.
FDA has weighed in on the use of these options with draft guidances. In July, the agency issued “Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting.” It covers “the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug.” Industry comments are due by October 13, 2009.
In January, FDA issued “Guidance for Industry: Standards for Securing the Drug Supply Chain—Standardized Numerical Identification for Prescription Drug Packages.” Comments poured in, with several questioning the eight-digit serial number, among other points.
You may be waiting for final guidance—or even regulations—before investing in specific technologies. But as the H1N1 product counterfeits demonstrate, the counterfeiters aren’t waiting. Neither are the opportunistic distributors or even pharmacists and clinic operators who are dabbling in counterfeiting, diversion, and fraud. On the right you’ll find an update on the arrests and convictions.
Identifying the source of counterfeits and making it too difficult to pass counterfeits through the supply chain are critical needs that technologies can meet. You have got to make it easy for supply-chain participants—which in some cases could even include patients—to identify and authenticate drug products.
You may also want to take action before standards firm up. While we don’t advocate a single security approach—hence our cover theme urging some means of scrutiny—we do believe that patient protection, not regulatory compliance, should be enough of a driver to begin layering in security.
Thankfully, recent reports of counterfeiting have not included mention of significant patient harm.
But what could happen if counterfeit H1N1 vaccines surface this fall? Patients could be harmed by substandard, poorly stored, or simply harmful injectibles.
In addition, if given fake products, patients won’t be vaccinated, leaving them vulnerable to the flu. Such crimes could make the current pandemic even more deadly.
Daphne Allen, Editor
Twitter name: @daphneallen