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Safety at the Speed of Life- Blog 6 (1 comment)

Posted by: Michael Leavitt
Monday, July 28th, 2008

I mentioned at the end of my previous post in this series on import safety that FDA’s role in global trade will be changing. FDA’s work is often underappreciated in this country. Nations around the world recognize FDA as the “gold standard” when it comes to food and drug safety. Under Commissioner Andrew C. von Eschenbach’s leadership, FDA is building on that “gold standard” by reaching out to new frontiers and globalizing the FDA.

FDA is opening an office in China with staff in three cities: Beijing, Shanghai, and Guangzhou. We are currently negotiating to do the same in India, with plans for additional FDA offices in multiple areas of Latin American, Europe, and the Middle East.

And we are changing how we do business. The traditional role of FDA as approver stands strong. How and where we do that is undergoing change.

The origin of all product standards, certification and inspection of goods does not need to start with FDA; it can start with the industry and in other countries as it did with shrimp.

This is a fundamental shift in government’s role. The 21st century role of FDA is as convener and arbiter as well as verifier and enforcer.

Will FDA be an aggressive enforcement entity? Yes. In fact, FDA’s enforcement resources will be better funded and more focused on the producers who have not demonstrated trustworthiness.

Will FDA be adopting safety standards as a regulator? Yes. But we will encourage industry to collaboratively develop standards for FDA to review. If they don’t meet the scientific rigor, we won’t accept them until they do.

While the United States is the largest economic player in the food and drug market, there are other nations with excellent systems in which we have great confidence.
In the past, each nation has conducted separate inspections. The result is great redundancy as several countries inspect the same plant — for essentially the same things, while too much time lapses between visits.

We are going to change that.

I announced recently a policy initiative where FDA will work more closely with foreign regulators who have systems of inspection and regulation we trust. The principle will be collaborative information gathering, individual decision making.

As part of that effort, FDA has initiated a pilot project with our colleagues in the European Union and Australia to jointly plan, allocate, and conduct international pharmaceutical inspections. This will begin with inspections of active pharmaceutical ingredient manufacturing. These are the “starting products” of many of the medicines we all use.

Through this new collaboration, FDA and these trusted colleagues can spread our inspection net wider by leveraging our respective resources. We will be inspecting some, the Australians others, the European Union still others. We will then share information. This just makes good sense. Facilities will be inspected more often and we can all focus more resources on those products that present higher risk.

This is a very exciting vision: common standards, common certification, and shared inspections. Safer products. Lower costs.

Finally, we need the private sector to step up big-time to initiate, lead, and participate in the development of consensus-based standards and independent certification. You have a responsibility to your consumers and to the integrity of your industry.

I will conclude this series in my next entry, sharing my final thoughts on how, together, we have a unique opportunity to influence the future of product safety.

One Response to “Safety at the Speed of Life- Blog 6”

Jeanne Sather says:

July 29, 2008 at 8:55 am

Re: the health blogosphere discussion tomorrow, you might want to know about our recent event in Seattle:

In the Seattle P-I:
Blogs help cancer patients cope with disease
http://seattlepi.nwsource.com/local/372201_cancerbloggers25.html

On my blog:
Why We Blog
http://www.assertivepatient.com/2008/07/why-we-blog-a-1.html

I’ll try to check in during the discussion tomorrow, but I had planned to be out of town and out of Internet reach. If you want to know more about me:

http://theacp.typepad.com/about.html

Thanks,

Jeanne

Jeanne Sather
The Assertive Cancer Patient
http://www.assertivepatient.com