The Food and Drug Administration has issued guidelines that, among other things, urge pharmaceutical manufacturers to be watchful and to notify the federal agency and trading partners when they get information leading them to suspect a high risk of an illegitimate product entering the market.
It is part of the FDA's broader effort to enhance its ability to help protect U.S. consumers by improving the detection and removal of potentially dangerous products from the pharmaceutical distribution supply chain.
"Overall, I think the purpose of the guidance is to provide some specific examples and contexts for when manufacturers should find substantial risk of [product] illegitimacy," due to tampering, counterfeiting and the like, attorney Karen Owen Gibbs, a partner at McDermott Will & Emery, told BioPharma Dive.
Essentially, the FDA's new guidance is "putting everyone in the distribution chain on notice that it expects vigilance," she said.
This is the federal agency's seventh piece of guidance related to the Drug Supply Chain Security Act (DSCSA). The law, enacted in November 2013, also includes new product identification and tracing requirements aimed at creating an electronic interoperable system that knows the transaction history of prescription drugs down to the package level. Manufacturers are facing the supply chain law's first requirements as the FDA continues to phase in its work on other DSCSA provisions under a 10-year implementation plan.
How to spot a bad drug
The agency's newly released 17-page document identifies various scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. It also offers recommendations on how trading partners – manufacturers, repackagers, wholesale distributors and dispensers (primarily pharmacies) – can identify a suspect product and make this determination "as soon as practicable." And the FDA's document describes when manufacturers should notify the FDA of a high risk that a product is illegitimate.
The portion of the FDA guidance describing when manufacturers ought to notify the FDA of a suspect product is being distributed for public comment purposes only. Comments are due within 60 days of the document's Dec. 9 release.
Since Jan. 1, 2015, a trading partner determining that a product in its possession or control is illegitimate had has to notify the FDA and certain immediate trading partners under the FD&C Act. The new guidance tries to identify some specific scenarios that could significantly increase the risk of a suspect product entering the supply chain and recommends ways in which to identify these products in a timely way.
According to Gibbs, the first part of the FDA's guidance stresses that the agency is putting the industry on notice to be alert to illegitimate products in the market. She said the document's second part, on manufacturers' notifying the FDA of high-risk products, is "an expectation," as the agency awaits comments to flesh out details on what exactly would trigger this notification requirement.
"Maybe a high-level takeaway is that the FDA is putting manufacturers and other trading partners on notice that it expects them to go beyond their own activity...and be aware generally of what may be happening in the market that really they're not touching at all," meaning even when products are not in their own hands or actually distributed by them, said Gibbs, former vice president and senior counsel at CVS Health.
In the most common distribution channel, from manufacturer to wholesaler to pharmacy, "now the FDA is saying if a wholesaler is reporting getting a counterfeit...you [i.e., the manufacturer] need to be aware of that, too," she said.
The FDA's new guidance does specify, among other things, that trading partners must have systems in place enabling them to quarantine a suspect product and promptly conduct an investigation, in coordination with other trading partners to determine whether a suspect product is illegitimate. The agency also specifies that trading partners, in going about their daily business, "should exercise vigilance, maintain awareness about suspicious activity or potential threats to their supply chain, and devote attention and effort to detecting suspect product."
Currently, many manufacturers are exercising this level of diligence anyway, Gibbs noted.
The new guidance also specifies FDA notification within 24 hours of the manufacturer becoming aware of a suspect product. The question is what triggers this 24-hour window, Gibbs said, noting that it's clearly when the manufacturer has some level of suspicion and prior to the conclusion of an investigation.
While much of the guidance is commonsense, the FDA specifically notes that it has its eye on several areas of potential concern, including high-demand products – and products with high sales volume or price – in the U.S. market. "The FDA is saying they want you to be extra-vigilant on high-demand products where such [illegitimate] activities are likelier to occur," Gibbs said.
Discussing specific scenarios that should raise red flags, the FDA also urges industry caution when receiving an unsolicited sales offer from an unknown source, perhaps through an email, fax, phone call or in-person sales call from someone with whom the trading partner lacks an established business relationship. The agency also warns about purchasing on the internet from an unknown source.
The guidance offers examples of how manufacturers and other trading partners can "expeditiously" identify suspect products, putting them on notice that the FDA expects them to be especially wary if, for example, a product is being sold "at a very low price" or at a price that is "too good to be true." The agency also recommends checking the product's appearance for such red flags as broken packaging seals and to closely examine package labeling for missing information, misspelled words and the like.
This may be stating the obvious, Gibbs said, but it "may be so the FDA can go back and say, 'It may be common sense, but we actually wrote it down for you.'"