Coping with an increasingly global device and drug industry will require a paradigm shift that relies less on FDA's own staff and more on data and resource sharing with other countries, the agency says.

"FDA's traditional model of manufacturing site inspections and border examinations is simply not adequate in today's transformed world," said John Taylor, who was recently named acting principal deputy commissioner of FDA following the departure of Joshua Sharfstein in January.

"The truth of the matter is that the increase in imports is just far outstripping the resources to address this issue," he emphasized at a Feb. 10 meeting in Washington, D.C.

FDA estimates that U.S. imports of regulated products including medical devices, drugs, food and cosmetics have increased three-fold over the last decade.

The agency is formulating a long-term global regulatory plan centered on greater data sharing and collaboration between state, federal and international authorities, Taylor said at the Health Leaders Dialogue, sponsored by public affairs and consulting firms Venn Strategies and Greenleaf Health.

"We at the agency are now engaged in initiatives aimed at creating an operational model and shifting the import paradigm to be more prevention-focused and global to meet today's challenges," he said.

Full details on FDA's globalization plan will be released for public comment, he said.

According to Taylor, FDA must devote significantly more resources to new approaches for international collaboration, including training and capacity building, harmonization of safety standards and sharing of information more freely between borders.

The new global oversight strategy will build on ongoing international efforts at the agency, such as the move to establish FDA offices overseas, Taylor explained. The agency now has foreign posts in China, India, Latin America and Europe.

FDA has also created a cadre of inspectors to deal specifically with foreign facilities - including 10 staffers to date.

But FDA's international work so far has been on a limited basis, and remains superimposed on FDA's old model of inspections-based oversight, Taylor said. "We need to do more."

For one, FDA is working toward safety standards that are comparable, if not equivalent, to other countries, "so that when we take a look at products from overseas and we need to determine the status of those products, we're not solely relying on our own investigators."

FDA wants to create a "global coalition of regulators" who are able to share data globally, thus increasing their scope and reducing redundancies for manufacturers, he added.

The agency also plans to rely more on third-party inspectors to fill the gap.

"Third-party inspection programs need to be a bigger part of the discussion so that we don't have to do the work all ourselves," Taylor said. "We simply cannot do it alone."

A Global Solution

FDA is not the only regulator struggling with increasing globalization challenges, Taylor noted.

The agency's foreign counterparts also face mounting problems with insufficient resources to handle them. "A global problem like this requires a global solution and global responsibility," Taylor said.

- Jessica Bylander (j.bylander@elsevier.com)

[Editor's note: This story appears courtesy of the editorial staff of 'The Gray Sheet,' your source for coverage of devices and diagnostics. For a free trial, call customer service at 800-332-2181.]

FDA Long-Term Globalization Strategy Under Development

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