Remarks as Prepared for FDA Globalization Media Briefing

Thank you all for joining us.

You’ve all heard the saying, “Time is money.” A few months ago, I heard a senior executive of a major retail chain put it another way: He said, “Speed is life.”

That’s was the motto his company lives by. As they see it, the faster they get products into the United States and on the store shelves, the bigger the edge they’ll have over their competitors.

Of course, whenever you’re in a hurry, you’re tempted to take risks. The challenge is to keep trade moving at a competitive speed without sacrificing safety.

A little over a year ago, President Bush directed a cabinet-level working group to conduct a comprehensive review of our import-safety practices. He appointed me Chair.

The Working Group conducted the most complete policy review ever on import safety. In our report to the President, we told him:  

“Mr. President,

“We have a good system of product safety today, but it is not adequate for the future and we need a fundamental change in our strategy.

“In the past we have stood at our borders attempting to apprehend products that don’t meet our expectations. 

“We cannot inspect our way to product safety without bringing trade to a standstill. Our new strategy must be to extend our borders and ensure that quality and safety are built into the products we import.

“We will do this by rewarding producers that have products certified to meet our standards. Their goods will receive expedited entry into our country. 

“We will make clear to those who don’t that they can expect enhanced scrutiny.”

You can read the report and the 50 specific recommendations we made at importsafety.gov. They are important, but the real transformation comes from the change in our basic strategy.

A centerpiece of our new Federal Government strategy is to encourage, leverage, and build upon such voluntary, third-party certification efforts. We are not inventing a new concept. It already exists. And it works.

We observed independent certification being used in many sectors of the import world. Until now, however, we have not integrated this capacity for improvement into our regulatory work.

In the future, products from those firms that meet U.S. standards and have been certified by a process we trust will receive expedited entry and access to U.S. consumers. Agencies like the Food and Drug Administration will be freer to focus enforcement resources on those suppliers that don’t have certified processes.

We are saying clearly to producers in other nations: “We want you to have access to American markets, and we want to have access to yours. To maintain your access, you must meet American standards of quality and safety. If you can demonstrate, through a process we trust, that your products meet our safety standards, we’ll be your partners in speed.”

We are working now to bring foreign producers up to U.S. standards of quality and safety. And we’ve seen some significant progress already.

• We have signed two Memoranda of Agreements with regulatory agencies of the People’s Republic of China, one on food and feed and one on medicines and medical devices.
• We have signed a Memorandum of Understanding on aquacultured shrimp with Vietnam.
• We are now negotiating the conclusion of similar MOUs with eight Latin American countries (Belize, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, and Panama). We expect to have it signed by the end of the year.
• We have held summits with major producers and retailers, both here and abroad, to impress upon them the need for independent, third-party, certification systems that meet standards acceptable to government regulators like the FDA.
• FDA is currently reviewing candidates in the aquacultured shrimp industry to participate in a third-party certification pilot program. We expect to announce those participants and move into the next phase of the pilot in early December.
• FDA is also working to finalize written guidance establishing FDA’s expectations for third-party certification programs for foods and feeds. We expect to finalize this guidance sometime this fall.
• We have initiated a pilot project with the European Union and Australia to jointly plan, allocate, and conduct international inspections of pharmaceutical manufacturers.  

Now we’re about to take another new step, establishing—for the first time ever—a global presence for the FDA. By stationing FDA experts in producing countries and regions, we can work with foreign governments and producers to assure that products exported to the U.S. meet our standards.

The FDA’s first permanent overseas offices will be in China. We are scheduled to have an FDA official in place in Beijing by the end of the year. Offices in Shanghai and Guangzhou will open next year.

We are working out the final, logistical details of these arrangements. I will travel to China in November to meet with Chinese health officials to review our mutual efforts to ensure the safety of food and medical products consumed by our peoples.

FDA also anticipates establishing a presence in India by the end of this year. The first office will be in New Delhi. The location of a second is still undecided, but we are looking at Mumbai. We’ve begun seeking the approval of the Indian government for these postings.

FDA personnel in India would work closely with Indian regulators and Indian industries shipping products to the U.S. FDA personnel would do more inspections in India. They would also work with government and the private sector to establish third-party certification programs.

FDA will also open regional offices in Europe and Latin America this year. A regional office in the Middle East is scheduled for opening in early to mid-2009.

There’s still work to be done, still some details to be worked out. But I’m confident things will move ahead as planned.

There’s no other way to keep the products we buy safe without slowing down international trade. And in our current economic situation, the last thing we would want to do is slow down trade. Now more than ever, we need to keep the gates of trade open to outside producers, while still ensuring the safety of imports.

We can have both speed and safety—by rolling back our borders, establishing a forward presence for FDA, collaborating with foreign governments and the private sector on science-based standards, and working with independent, third-party certifying agencies to see that products meet those standards.

Last revised: January 12, 2009