Import with Care: New Import Safety Rules Put Forth by Multiple Agencies

When you think of the government stepping in to tighten up supply-chain safety, stories like that of convicted counterfeiter Ryan Wheele may come to mind. In 2005 and 2006, hundreds of prescriptions of Viagra, Cialis, and Levitra were filled by an Internet pharmacy and shipped to patients in vials with prescription labels. Trouble is, there was no pharmacy, there were no prescriptions, and there wasn’t even any Viagra, Cialis, or Levitra. In December 2007, Ohio resident Wheele pleaded guilty to conspiracy and trafficking in counterfeit prescription drugs. Wheele’s alleged operation? Shipments of counterfeit pills from Pakistan, India, and Great Britain were sent to Wheele by a coconspirator. He would then fill vials by hand in a home basement shared with pet cats and ship the vials out to unsuspecting patients, the U.S. Department of Justice (DOJ) reported.

Feel like reading a little more true crime? You’ll find countless reports of counterfeit imports making their way into the hands of crafty individuals around the country at www.usdoj.gov.

But suspected counterfeits aren’t the only imports the DOJ is eyeing for increased scrutiny. The DOJ, the Department of Health and Human Services, the Department of Transportation, the Department of Homeland Security, the Office of Management and Budget, the Consumer Product Safety Commission, and other agencies are banding together to form the Interagency Working Group on Import Safety.

The group will be looking at all imports, even raw materials imported for manufacturing in the United States. “The import-safety chain stretches from the point of foreign origin, both of materials and finished product, to domestic consumption or use. All entities involved in the import life cycle—foreign producers (growers and manufacturers), governments, distributors, and exporters; U.S. importers, distributors, manufacturers and retailers; testing and certification bodies and regulatory authorities at the federal, state and local levels—must work together to prevent unsafe products from entering the United States,” reads the group’s action plan. It can be found at www.importsafety.gov. “The appropriate entities in the supply chain must also take swift and effective action when harmful products do enter domestic commerce.”

Imported pharmaceutical and medical devices and any materials imported to manufacture them are included in the plan’s scope, but how their safety will be ensured isn’t as spelled out as much as are plans for food and toys, for instance. Nonetheless, if you import raw materials or ingredients, your supply chains will be affected by heightened scrutiny.

In its just-released “Good Importer Practices” draft guidance, FDA states that “importers should put into place controls for known vulnerabilities, such as microbiological contamination and product defects, and monitor for other risks, such as counterfeiting or intentional contamination.”

You may feel as though you have those controls in place for your imports. FDA wants to be doubly sure. In its first guiding principle, titled “Establishing a Product Safety Management Program,” FDA advises firms to “assign responsibility for product control and compliance to specific individuals and ensure they understand their role in the organization.” What transport packaging responsibilities come into play when importing materials? “The importer should have sufficient knowledge of the product . . . its inherent vulnerabilities and risks, and the methods by which it is . . . packed, received, transported, stored, imported, and distributed.”

For instance, when receiving imported pharmaceutical goods, your responsibility entails ensuring that the ingredients are authentic and that they have been packaged and handled in such a way to maintain their safety and efficacy. Temperature and humidity control come to mind as two definite musts when transporting pharma goods. Also, I have had pharmaceutical packaging professionals tell me anecdotally that they have had to protect shipments against sunlight and salt air when traveling by ocean. Some have even had to guard against human traffickers that attempt to add a little extra to freight containers. Those risks underline the importance of this bit of FDA advice: “Know the risks and compliance history of the products you import, and of the firms that manufacture, distribute, or transport those products.”

FDA also emphasizes compliance with U.S. requirements during product travels throughout the supply chain. “Know what preventive controls, if any, firms must institute at each critical point in the product’s life cycle, and the steps firms need to take to ensure that those controls are being appropriately applied,” FDA states. Do you need to employ robust temperature- or humidity-tracking devices throughout your imports’ journey? What about tamper-evident cargo seals or even global-positioning systems to make sure your imports stay intact and on track?

Making information about imports readily available seems to be a common goal. It may even need to be available before imports reach U.S. borders. “The more data that can be captured early in the supply-chain process, the better,” explains Donald P. Bliss, National Infrastructure Institute, who is quoted in the action plan. “If U.S.- based importers, retailers, and government agencies can identify product safety problems in the manufacturing or transportation stages before a product reaches the U.S. market, the public will be safer, and enforcement and recall costs will be significantly reduced.”

Track-and-trace technologies may have a role to play. “In order to identify the source and destination of a potentially violative product, the importer should consider whether it should be able to trace the product from its origin to its destination,” FDA states in draft guidance. “This would facilitate the removal of the violative product from the marketplace as well as identify other implicated products. Importers should consider using contract provisions that require the use of track-and-trace technologies to accomplish these objectives.”

FDA believes that third-party support can be of assistance. It is seeking “legislative authority to accredit independent third parties to evaluate compliance with FDA requirements.

. . . FDA will accredit third-party organizations, or recognize an entity that accredits third parties. Third-party organizations could be, as appropriate, federal departments and agencies, state and local government agencies, foreign government agencies, or private entities without financial conflicts of interest. FDA would use information from these accredited third-party organizations in its admissibility decision making.” The group action plan lists this as a “short-term” goal.

In keeping with FDA’s now typical risk-based focus, the import safety action plan “is built on the concept that focusing on risk is the most effective way to address safety over the broad spectrum of products imported by the United States. Some areas and products need more attention than others because of the potential risks they could present and because of differences in the product and the production environment. These differences include process controls, the history of compliance, the intended use of the product, the inherent risks of the product, and other factors demonstrated by science and experience to be valid predictors.”

Safe importing standards would authorize border staff to destroy “medical products refused admission into the United States. The federal government has had limited success in stopping unsafe medical products for personal use from entering the United States because of the statutory requirements that must be met before those products are destroyed. Expedited destruction of these products would address this limitation but would only apply to refused shipments that are valued below a certain threshold or which pose a certain level of risk to humans or animals. This is intended to address problems, such as personal shipments of drugs being reimported after they have been denied entry.”

FDA, along with other U.S. government agencies, are definitely stepping up efforts to encourage import safety as the supply chain of almost every product stretches around the globe.

FDA calls its advice guidance, however. With a tight budget in a tough economy, FDA is expecting industry accountability when it comes to ensuring import safety. U.S. manufacturers can trust their overseas suppliers, but they also must verify that these supplies meet U.S. safety requirements, among other laws.

Daphne Allen
Editor
daphne.allen@cancom.com

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