Resident Fellow Scott Gottlieb

Attention has turned to these shortcomings after popular brands of pet food were contaminated with a chemical that killed or sickened thousands of cats and dogs. The pet food episode is only the latest in a string of problems stemming from raw materials to food and drug products imported from developing countries. In Panama, for example, at least 51 people have died since October after using cough syrup tainted with a chemical cousin of antifreeze. The deadly ingredient originated in China.

The Food and Drug Administration (FDA) has primary responsibility for inspecting shipments of drugs and most foods. Though no regulatory system can eliminate every risk, our present approach isn't adapted to deal with the fact that companies are sourcing more of their raw materials from less developed countries that don't have the same regulatory protections in place as the United States does.

To address these gaps, many in Congress have proposed to merely increase the FDA's current activity, testing more shipments of raw goods, for example, or adding inspectors to peer inside more cartons at the border. Buffing up our inspection model doesn't help us better address the changing nature of risks we face.

Staffing Shortage

It's true that FDA never permanently received the number of inspectors it was promised shortly after 9/11 to improve oversight of food from deliberate tampering. I recently left the FDA, where I worked as a deputy commissioner, and staffing shortfalls were a daily burden. But adding manpower won't go very far. Neither will merely testing more batches of goods, which can be prohibitively expensive.

Our inspection model at FDA worked better when the volume and complexity of imported products were small, grew slowly and were limited to a smaller set of goods. But the FDA can no longer be globally dispersed, sending its dwindling cadre of increasingly reluctant inspectors into every foreign factory. They don't speak the language, understand the culture or know the local criminals. FDA needs to target its inspection resources more effectively to areas of highest risk and monitor reputable firms empowered by the agency to police their own supply chains.

The United States still has the safest food and drug supply in the world, but the need for a new approach is necessitated by the dramatic changes in the nature of the food and drugs arriving in the USA from other countries. FDA processed 15 million shipments of goods in 2006, up 60% since 2003. Products arrived from more than 230 countries and more than 300,000 manufacturers. More and more drugs, especially generics, get their raw material from China and India, where local controls are weak. Against this, FDA has about 625 inspectors for foods and 260 for pill-type drugs.

Innovations in distribution and supply chains also mean imported products can be widely distributed shortly after crossing our border, amplifying risks. Many imports come from countries that don't have the same market pressures as the USA's. American brands can be decimated when things go wrong. That serves as a more potent deterrent to bad behavior than any sanction that a regulator can levy.

The FDA also needs to be able to better identify and prioritize risks from imported products all along their life cycle, and not just at the border. Rather than remaining a primary line of defense, the border needs to be a checkpoint to make sure foreign firms have complied with health and safety requirements along the supply chain. This requires better information about goods coming in and more cooperation with foreign agents so FDA can identify highest-risk products.

Some Progress

Recent FDA changes in the inspection of some imported food in response to concerns about terrorism are working and provide a foundation for building a more modern, risk-based approach to inspecting all of our imports. The bioterrorism-focused system uses information that FDA collects from importers, and greater cooperation with overseas law enforcement and regulatory agencies, to make targeted decisions about which imports to sample based on the possibility for tampering. Top-secret software used to analyze risks means that products such as loose spices imported from the Middle East probably will get far more scrutiny than whole produce from Canada.

Firms also need to take more responsibility for the quality and safety of ingredients they buy overseas. In China, U.S. drug companies are turning to private outfits to independently audit raw material suppliers, and a private U.S. drug standards outfit recently set up shop there for this purpose. Ultimately, FDA needs to enable companies to be inspected by private third parties certified by the agency.

Our current system was never given appropriate resources or direction to address the complex problems posed by globalization. Dealing with modern risks will require not just jerry-rigging our existing model, but a fundamentally new blueprint.

Scott Gottlieb, M.D., is a resident fellow at AEI.