FDA Plans to Extend Its Global Regulatory Reach

June 20, 2011 — The US Food and Drug Administration (FDA) plans to take a more global approach to ensure the safety and quality of regulated drugs and medical devices, the agency's commissioner announced during a media briefing today.

One prong of the new 4-pronged approach will involve partnering with counterparts worldwide and creating global coalitions of regulators intent on ensuring and improving global product safety and quality, said FDA Commissioner Margaret Hamburg, MD.

"This is a long-term strategy," Dr. Hamburg said. "It cannot be accomplished immediately and will probably take many years to implement, depending upon resources."

One part of the new approach will mean regulators no longer regard borders the same way. "The border can no longer be the nation's primary line of defense against unsafe imported products," she said. "Instead, the border must serve as a final checkpoint on preventive controls throughout the supply chain."

An FDA report, Pathway to Global Product Safety and Quality, describes the new strategy. Most notably, it calls for the agency to change how it conducts business and to take a more global approach to promote and protect the health of US consumers. Highlights of the report include 3 other prongs of the 4-pronged approach:

• The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.


• The FDA will build in more information gathering and analysis, with an increased focus on risk analytics and information technology.


• The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

Such coalition-type models do not exist in the world of FDA-regulated products, said John Taylor, JD, acting principal deputy commissioner of the FDA, and the FDA does not already have a coalition in place. However, many peer regulators have expressed interest in working more closely together to ensure the safety and integrity of products moving through the global supply chain.

Current Regulatory Authority Outdated

When asked whether the FDA would need new authority from Congress to proceed with the project, Taylor said the agency would move ahead with the strategy regardless of whether it needs new authority to do so. He also noted that the agency's authority relating to medical products is outdated. In 1938, the authority given to the FDA largely grew out of a world where manufacturers of regulated products were based in the United States.

"We've been a domestic agency that works in an international world," he said. "What we need to do is transform ourselves into a global agency that is able to work all around the world and address product issues that arise all over the world."

Taking a more global approach will enable the FDA to better monitor companies in far-flung areas that might otherwise escape regulatory scrutiny as more FDA-regulated products are produced overseas.

Global production of FDA-regulated goods has exploded over the past 10 years, according to Dr. Hamburg. Manufacturers increasingly use imported materials and ingredients in their US production facilities, "making the distinction between domestic and imported products outdated, to say the least," she said.

Products regulated by FDA, Dr. Hamburg said, reflect the globalization of today's economy:

• 10% of all imports into the United States consist of products FDA regulates,


• 80% of active pharmaceutical ingredients in the drugs Americans use come from overseas,


• 40% of drugs themselves are imports, and


• about half of all medical devices used in this country are imported.

Yet the FDA does not have the resources to keep pace with demands created by globalization, according to the report issued today that describes the FDA's new plan. In 2008, the Government Accountability Office recommended that the FDA increase inspections of foreign drug companies, but at current rates, it would take 9 years for the agency to inspect every high-priority pharmaceutical facility just once.

The new strategy would build on changes already made by the FDA. Between 2007 and 2009, the FDA increased the number of foreign drug manufacturing inspections by 27% and opened international offices in several key locations around the world.

The FDA has also collaborated with counterparts in the European Union and Australia on drug inspections, and it has joined an organization of drug manufacturing inspectorates from 39 countries. The FDA and other global leaders are also creating an expanded global regulators forum for medical devices.

More information on the new strategy is available on the FDA Web site.