After Supply Chain Breaches, FDA Looks to Better Communicate Risks of Counterfeits

Posted 15 July 2013 | By Alexander Gaffney, RAC 

An upcoming advisory committee of the US Food and Drug Administration (FDA) is set to discuss how the agency can engage in best practices for communicating with health care professionals and others about the risks of counterfeit and unapproved drugs.

Background

US regulators have been seeing an influx of counterfeit products in recent years, testing both the limits of the security of the pharmaceutical supply chain and the ability of regulators to stop products before they reach consumers.

A recent report by the US Customs and Border Protection (CBP) agency, for example, showed nearly $82.9 million in pharmaceutical goods seized in the year preceding the report. While that number was down significantly from the prior year's report, 2012 was marked with some significant lapses in the US supply chain.

Foremost among those lapses was the early 2012 discovery of counterfeit Avastin, which regulators said had been smuggled into the country and sold by an unauthorized supplier to doctors who were trying to cut down on their costs. At the time, FDA sent out a number of warnings, including notices that products should be "Retained and securely stored until further notice."

Then, in May 2012, FDA warned consumers that counterfeit copies of Teva Pharmaceutical's Adderall had been obtained by consumers through an online pharmacy. At the time, the drug was experiencing widespread shortages, leading many consumers to look to less-reputable sources to obtain the drug.

Effective Communication

While FDA has obtained new authority in the last year to go after counterfeiters - and to punish them - it apparently is still grappling with a more fundamental problem: How does it effectively communicate with health care providers and stakeholders regarding counterfeit and unapproved products?

Part of the problem is evident in the language used in the Avastin warning. Unlike most regular warnings, in which FDA or a firm may issue a recall notice ordering the return of a product, counterfeit or unapproved drugs will likely need to be seized to facilitate an investigation or their destruction. In addition, markings on the products may be incorrect or inconsistent, making it more difficult to determine which products are genuine and which are fake.

And even when health care providers are instructed to only use approved suppliers, such as in the case of Avastin, sometimes the allure of higher profit margins can be too much of a temptation.

On 16 August 2013, FDA's Risk Communications Advisory Committee is scheduled to discuss how it can "communicate more effectively" with stakeholders regarding the risks associated with counterfeit and unapproved drugs, according to a Federal Register notice published on 15 July 2013.

In addition - and perhaps in a direct nod to the Avastin controversy - FDA said the committee will discuss "safe purchasing practices," as well as ways that FDA can evaluate the impact of its communications.

Background materials for the meeting are not yet posted, but are generally available several days before the meeting.


Federal Register notice


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