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Opportunities and Challenges in Health Care Exports

Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
2011 Export-Import Bank Annual Conference
Thursday, March 31, 2011

Good afternoon—and thank you for inviting me to be here today.

We are at a critical moment. Advances in science are leading toward a fundamental change in the way medical treatments will be developed and used. Groundbreaking discoveries in complex chemistry and biosynthesis have promised new drug candidates. And cutting-edge electronics, nanotechnology, and materials science have revolutionized medical devices.

And we’re living in a global economy in which demand for medical products is rising—both in the U.S. and abroad. Since 2004, the global med tech market increased by more than 50 percent to nearly $250 billion, and we expect it to continue to grow in the coming years.

The result is an incredible opportunity for American companies.

The U.S. holds a competitive advantage in many of the industries on which medical devices rely, such as microelectronics and biotechnology, and we are the largest producer of med tech products in the world—constituting nearly 40 percent of the world’s total in 2010.

Efforts to increase the export of medical equipment from the U.S., like those of the Export-Import Bank’s Medical Equipment Initiative, will allow us to continue to expand our presence.

Despite the global and U.S. economic downturn, the medical device and pharmaceutical industries continue to thrive as two of the few U.S. manufacturing sectors with a trade surplus. In fact, over the past ten years, exports of medical devices increased from almost $25 billion to nearly $45 billion, while imports increased from less than $25 billion to just more than $35 billion. On the pharmaceutical front, the output from New Jersey alone nearly matches the output from all of Asia.

As the agency responsible for the approval and regulation of medical devices, the Food and Drug Administration plays a critical role in industry’s ability to perform and compete in the global marketplace. We recognize the high stakes in maintaining our presence as a global leader, and we are committed to modernizing our science and regulatory paths to drive innovation forward.

FDA has historically been a regulatory leader on the world stage. We consistently approve new drugs and devices faster than any other country, while still maintaining the high safety standards that Americans expect.

But we are constantly taking proactive steps to be even better. As the industries whose products we regulate adapt to the changing global landscape, we are adapting with them. We’ve identified ways to streamline our regulatory processes, increase transparency, and provide more clarity to the private sector. And, importantly, we’ve placed a renewed emphasis on driving scientific innovation.

As part of our innovation initiative, we recently announced plans to overhaul our 510(k) process, which allows for expedited review of around 90 percent of FDA-regulated products. Under these reforms, we will streamline 510(k) submissions for eligible devices, clarify criteria for eligibility, and provide a more efficient review process.

Earlier this year, we announced 25 specific actions to improve the predictability, consistency, and transparency of our premarket review programs. We also announced a priority review program for pioneering technologies, aimed at encouraging and fostering the development of cutting-edge medical device technologies, strengthening the nation’s research infrastructure, and advancing quality regulatory science for all medical devices.

Through his National Export Initiative, President Obama pledged to double U.S. exports, and we—all of us here in this room today—play an important role in realizing that goal. From our end at the FDA, we will continue to work closely with our partners in industry and academia to drive innovation and streamline the process to get new products approved.

This is an exciting time for the medical and biotech industries, and it is important for American companies to seize the opportunity to increase our presence in the global marketplace.

And with that, I am pleased to turn things over to our moderator, Dr. Pat Basu.