FDA Launches Initiative Aimed at Imports

There is no question for even the most casual observer that the exploding globalization movement of the 1990s has led to expansive imports during the decade I like to call the Uh-ohs (2000s).  Globalization has brought with it many benefits.  For example, we have fresh fruits and vegetables all year round – some of which we had never heard of before.

But there have been risks as well.  On the food side, one will recall the series of issues involving the presence of melamine in a wide variety of foods, including pet foods, that resulted in widespread recalls and illness in 2007.  And on the drug side, contaminated heparin spread around the globe, with at least 81 deaths attributed to it in 2008.   Those are only two of the more memorable examples of the risks that can be associated with the production and importation of food and medicines from around the globe.  Benefits come with risks.

Today, the FDA announced a new global initiative aimed at bolstering the safety of imported products.  In the press release announcing the initiative, FDA Commissioner Hamburg notes that with the explosion of manufacturers and ingredients from around the globe all having a hand in the development of products – the distinction between domestic and imported products is “obsolete” and she calls for the implementation of a “dramatic change in strategy” to deal with the issues.

Unfortunately, there are limits to what the FDA can do and the steps outlined, while sensible and important, may not necessarily be described as dramatic.  According to the release, there are four key elements needed to make the change:

1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.

2. 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.

3.  The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.

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

These actions are a good start, but beg the question whether it is enough.  Dr. Hamburg notes in her remarks that since 2000 imports have quadrupled and that FDA has increased the number of foreign drug manufacturing inspections by 27 percent between 2007 and 2009.  In addition, on the food side, while the Food Safety Modernization Act was passed into law and is aimed at supporting FDA’s efforts in the safety of imports, it so far is not getting the funding support it needs for full implementation by Congress.

The safety initiatives announced are important, seeking to involve foreign governments. In the long term, however, the full engagement of all stakeholders, including affected industries, in a more comprehensive strategic effort may be needed to more fully step up to the many challenges posed as the distinction between foreign and domestic goods becomes “obsolete”.

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