Safety at the Speed of Life- Blog 6

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.

Comments

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
www.assertivepatient.com

Posted by: Jeanne Sather | July 28, 2008 at 06:30 PM

As a woman who has had children and lost children, I feel that the ability to have a method that is safe for me to prevent pregnancy is not only critical, but a right of any woman.
As a nation we are so far behind other industrial nations in all of our actual care of our people (Iam not talking about our research,drug development, experimentation but actual available care)that to further cut or change the little available to those without insurance (the majority) is a crime and should be thought of as such. We continue to treat birth control as wrong instead of the acknowledgement that it is the only way for survival of the species at this time in history. Has anyone noticed that bludging population correlates to famine, disease, infant mortality and violence in countries that deny birth control?
Answer Scott Swenson's question, so that we all know where you stand on Bush's proposed disregard for women's health issues.

Posted by: Pierre Thompson | August 06, 2008 at 09:14 AM

Secretary Leavitt:
I'd like to understand why you did not respond to the recent serious question about contraceptive health care and whether it is seen as birth prevention or termination of life by your administration. It was raised by Scott Swenson, but I think all Americans deserve straight forward answers from our public servants.
Gerald Bates
[edit]

Posted by: Gerald Bates | August 06, 2008 at 11:18 AM

Althought not receiving the media attention this issue deserves, in what appears to be a spectacular act of complicity with the religious right, the Department of Health and Human Services Monday released a proposal that allows any federal grant recipient to obstruct a woman's access to contraception. In order to do this, the Department is attempting to redefine many forms of contraception, the birth control 40% of Americans use, as abortion. Doing so protects extremists under the Weldon and Church amendments. Those laws prohibit federal grant recipients from requiring employees to help provide or refer for abortion services. I would like to know why Sec. Leavitt would even consider any draft language that would seek to include the birth control pill as an abortifacient when there is no medical proof that it is.
I find it appalling that my right to contraception is about to be infringed because some pharmacist or nurse is an evangelical who is opposed to me receiving a medicine that is vital to my health and well-being.

Posted by: Ann Huntley | August 06, 2008 at 02:20 PM

YOU ARE SELLING OUT AMERICAN WOMEN BY REDFINING CONTRACEPTIVE

Posted by: carly | August 06, 2008 at 04:27 PM