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U.S. Department of Health and Human Services

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III. FDA must substantially change its operating model to address the challenges of the future

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FDA is one of the world’s oldest food and drug regulators with a reputation and proven track record for being a leader in product safety and quality.  As it looks to the future, the agency can no longer rely solely on its historical tools and activities to regulate products.  A part of this transition will include realignment and refocusing of existing global safety resources as well as a more strategic engagement with foreign counterparts to emphasize tangible steps to improve product safety and quality.  The reality facing FDA is that its mission will become ever more difficult to fulfill given the breadth of industries that it regulates combined with available resources.  It is imperative, therefore, that FDA finds the most effective way to revise the approaches and tools at its disposal and leverage relationships beyond the agency to other federal departments, the states, foreign governments, and industry.

 a. There has been little change to the fundamental operating model for regulators over the past several decades.

When Congress passed the Pure Food and Drug Act of 1906, the precursor to the legislation creating FDA, the industry that FDA regulated was predominately local, the volume of imported products was low, and even the movement of goods across country was minimal.  Public concern about a lack of oversight of U.S.-produced goods for domestic consumption and for export was the driving force behind the legislation.  Therefore, the authority granted under this legislation was sufficient to ensure the safety and quality of products at that time.  This authority allowed FDA to visually inspect regulated products presented at the border for import and to refuse entry to goods that appeared not to conform to the relevant safety requirements. 

Since then, innovations in refrigeration, transportation, and communication have enabled consolidation and globalization, particularly in food production, contributing to the rise in food imports.  Likewise, the transport of drugs, medical devices, and biologics over long distances while maintaining stability and product integrity has become commonplace, leading to increased levels of importation.  While high-profile domestic incidents have provided stark reminders of the important role that FDA plays in regulating U.S. companies, the trend toward globalization has increased public awareness about the safety risks of foreign imports.  These public health concerns represent a marked shift from the oversight issues that had been the focus in the past.

Recognizing these trends, FDA has made changes to its approach.  For example, the agency has, in the last several years, started moving toward an approach which takes into account the risks across the product’s life cycle, from production abroad to consumption in the U.S.  FDA has developed the PREDICT system, which uses risk based data and analytics from the entire life cycle of the product to make entry admissibility decisions, rather than just relying on border inspections.  FDA has also taken many other steps such as increasing its collaboration and information-exchange with its foreign counterparts, employing sophisticated risk models, developing advanced handheld testing for use at the border, and educating industry about how to minimize risks to products and supply chains.

Despite these incremental improvements, FDA’s underlying approach to import safety has remained relatively unchanged.  Throughout its existence, the agency’s primary tools for global product safety and quality have been facilities inspections and border inspections and remain so today.  This has been supplemented over time with additional tools such as laboratory sample analyses for select product categories (e.g., foods) and product safety reporting systems. 

One might suppose that, given that FDA’s operating model has served it well over the years, one option to meet the challenge of assuring product safety and quality in a globalized world is to scale the current model.  However, achieving a comparable average inspection frequency of foreign facilities would require a significant increase in resource levels as shown in Exhibit 11 below.  An alternative approach that relies on enhanced intelligence and data-driven risk analytics and allocation of resources achieved through partnerships has the potential to achieve greater levels of assurance of product safety and quality and do so with fewer resources.



Exhibit 10 – Cost and coverage of foreign inspections

Graph showing the average cost of foreign inspections ($53,000) is two times the cost of a domestic inspection ($23,000). From the years 2002 -2007 foreign inspection coverage for drug manufacturing facilities was 46%, foreign medical device facilities was 36%, foreign food firms 1%.

Traditionally, and with very few exceptions, FDA has used its own employees to perform all oversight activities.  Alternative approaches including third-party inspection programs and international cooperation have not been the primary focus.  Given the significant change that will be required to cope with future trends in global product safety, FDA will need to continue to identify ways to innovate in its oversight efforts and work with its federal partners to develop the necessary tools and authorities.

For food products in particular, the recent passage of the FDA Food Safety Modernization Act (FSMA) offers many opportunities to move toward a system that focuses on ensuring the safety of products prior to arrival at the border.  FSMA, signed into law by President Obama on January 4, 2011, gave FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities.  Under the new law, FDA will have several new mandates with respect to food produced outside the U.S.  Importers will face increased accountability; for the first time they will have an explicit responsibility to verify that foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe.  The agency now has explicit authority to refuse entry into the U.S. of food from a foreign facility if FDA (or other individuals duly designated by FDA) is denied access by the facility or the country in which the facility is located.  Finally, the FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards.

b. Current international efforts at addressing these challenges are not sufficient.

Despite significant effort and investment of resources, FDA’s successes in engaging foreign partners have not helped the agency substantially increase the coverage of its safety and quality assurance activities.  To date, FDA has taken a range of different approaches to international collaboration ranging from training and capability building, to harmonization of highly technical safety standards, to its recent admission into the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S system) of information sharing regarding pharmaceutical facility inspections.  These interactions have been immensely helpful in building positive relationships with counterparts and enhancing skills in a number of different countries and have given FDA valuable insight into the challenges that others have been facing.

However, the more complex, globalized environment anticipated in the near future requires FDA to make faster progress toward meaningful collaboration and impactful output than some of the current programs are on pace to produce.  Some programs have begun to move the world toward strong, common safety standards, but FDA has only used these as an acceptable alternative to its own standards in limited circumstances.  For example, at the current rate of progress and through the current mechanisms, it would take decades to reach a comprehensive set of common standards that could form the basis for FDA to leverage the work of public and private third parties both domestically and abroad.  This is due to extensive negotiations and careful consideration that is exerted by participants, including FDA, in these international programs. Yet serious global safety risks loom on the horizon and warrant near-term, tangible activities that cannot wait for existing programs alone to run their course. 

c. Several of FDA’s foreign counterparts have begun to implement innovative solutions to address the global safety challenges facing FDA.

Like FDA, food and medical product regulators around the world have begun efforts to become more effective and efficient at global product safety and quality oversight.  Some regulators in Asia have made the strategic decision to rely on the determinations of certain trusted foreign counterparts, directing their own resources instead to facilities and jurisdictions that are not already covered by these trusted parties to help expand capacity by reducing duplicity of effort.  Similarly, Mexico recently announced that it would treat device reviews conducted by FDA as equivalent to reviews conducted by Mexican regulators and Costa Rica has announced its intention to do the same.  In Europe, each drug manufacturer is constantly supervised by a qualified person employed by that manufacturer but responsible to the government for ensuring the safety and quality of all batches of the approved product, regardless of where it was produced.  More recently, a sub-set of the PIC/S participating countries have established a work-sharing program founded on the standardized inspection information-sharing developed through PIC/S.  Other jurisdictions have also created a tiered approach to facility inspections, adjusting the length and depth of the inspection based on the degree of risk associated with the particular facility, enabling those countries to quickly conduct a large number of inspections of low-risk sites.

New and innovative approaches to enhance regulatory effectiveness, including the PREDICT system and the opening of foreign offices, have been met with some success.  However, there is a need to move beyond these efforts and to think strategically across FDA and a network of regulators worldwide about what is needed to effect a substantial enhancement of global product safety.

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Forward to: IV. FDA is pursuing a strategy with four primary componets to address the coming challenges