Product Safety Risk Still Overlooked

Government and industry have failed to confront this white elephant jointly. Concerted efforts, focused on risk, will be essential, asserts Carl Nielsen, FDA's former director of Import Operations and Policy, in this exclusive commentary.

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By Carl R. Nielsen, former director, FDA Division of Import Operations and Policy

All best practices for drug manufacturing, QA/QC, purchasing, receiving, marketing and transportation help to reduce the threat of counterfeiting and other drug security risks. It stands to reason, then, that we should recognize and integrate those best practices for credit in the selectivity criteria for imports.

Currently, all drug entries are considered suspect by FDA, regardless of whether best practices that ensure safe and effective products in a secure supply chain have been implemented. The current FDA business model emphasizes compliance with border procedure. Consequently, each entry is reviewed by FDA. The data reviewed is largely from manifest and invoice information; there is very limited information for assessing risk for counterfeiting or other significant risks.

Industry has a key leadership role in determining how to accomplish this risk-based integration. Too often, and perhaps justifiably, industry views FDA interaction as a risk requiring mitigation rather than a partner in combating a common enemy. It’s time for FDA to leverage these best practices in order to expedite importation and ensure greater drug security.

The Agency’s soon-to-be-released Import Strategic Plan (ISP) should aid in these efforts by encouraging FDA participation with industry partners and other federal and state entities. The ISP is a risk-based approach that considers relevant information from the entire supply chain, from the foreign manufacturer to the U.S. consumer.

The ISP broadens the scope of import strategies to mitigate public health risks to chains of supply on both sides of the border. Nevertheless, FDA can do more in the short term by leveraging existing internal information with drug industry information to develop a business model designed to assess risk of an entry before goods arrive at U.S. ports.

Let’s consider an example of why change in entry processing is needed. Let’s say that Foreign Manufacturer A (FM-A) holds an ANDA or NDA for drug “Q”. The drug is manufactured in compliance with requirements of the application and cGMPs. Effective change control procedures are in place. Sources of active ingredients and other significant components are regularly audited, and FM-A monitors, maintains, and trends chemical and other relevant profiles of incoming components for acceptability.

In addition, FM-A designs and implements covert and overt technologies to enable rapid authentication of product “Q” at any point in the supply chain to ensure secure delivery. The commercial chain starts at the manufacturer’s loading dock and ends at the pharmacy shelf in the U.S.

A U.S. buyer orders “Q” from FM-A’s U.S. distribution center. FM-A packs and seals shipping container of product “Q” destined for the U.S. A third party verifies the condition of container at port of lading and the customs broker files entry. Customs and Border Protection (CBP) checks financial accounts for compliance status and quickly provides conditional release of the shipment to FDA.

However, FDA sends a notice of action and a document request to ensure product “Q” is covered by a valid ANDA or NDA. The shipment sits at the U.S. port for days incurring costs until the FDA “entry reviewer” is “satisfied” that FDA’s technical procedural import requirements are met. FDA performs no physical examination but releases the shipment. Eventually, the U.S. distributor examines and accepts the incoming shipment and delivers to the buyer, but not before costs have risen and product value has fallen.

Certainly, drug counterfeits in the U.S. market are a risk. A key component for risk mitigation strategies is to identify secure streams of commerce delivering safe drug products so that scant FDA resources are not spent reviewing or examining low-risk products. At the same time, industry needs a return on investment for best practices. Expedited entry processing should be one of those returns.

Collectively, the import and trade community has all the information it needs to develop effective border business models based on risk. FDA already has the technical capability to set selectivity or “may proceed” rates for compliant, low-risk shipments by foreign manufacturer, shipper, ports of entry, importer of record, consignee, and product code.

FDA and CBP need to do more to recognize best practices and expedite low-risk drug entries. There needs to be consensus as to what constitutes a low-risk drug entry. CBP has one notion of risk, FDA another. CBP initiatives on shipping container security need to be linked to FDA’s risk assessment for product safety and security to better ensure a secure supply chain.

It is one thing to say the arriving container is safe from a CBP perspective. It is quite another to say the drug products packed in the container are safe and secure. If CBP and FDA integrate border processes effectively, they should recognize field resource savings, and at the same time have an outcome-based operation rooted in good risk assessment and management practices.


About the Author

Carl R. Nielsen is a 28-year veteran of the FDA with extensive experience in and knowledge of FDA science, inspection, compliance, law enforcement, and international and import policy, procedure, and regulation development, implementation and enforcement. When he retired from FDA in February, he held the position of Director, ORA’s Division of Import Operations and Policy. He was one of the principal engineers of FDA’s soon-to-be-released Import Strategic Plan, designed to reinvent FDA’s import programs to focus more on risk-based processes. He is in transition establishing a consulting service and resides in the Washington, D.C. area.


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