FDA Matters Blog

Archive for the ‘Food Issues’ Category

FDA’s “Summer of Safety Concerns”

Sunday, September 5th, 2010

One of industry’s great fears is that FDA will become obsessed by theoretical or miniscule safety concerns and ignore the difficult realities of providing consumers with a varied and plentiful food supply and providing patients with effective medical therapies.

It is even possible to think this has occurred. It has been a long summer of media and Congressional attention to safety: whether drug manufacturing, medical products already on the market or Salmonella contaminated eggs. A closer look suggests to FDA Matters that theoretical safety risks and inappropriate FDA concerns about safety are not the issue. (more…)

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Hot Town, Summer in the City—2010

Sunday, July 11th, 2010

For the news media, the only FDA story this coming week will be the two-day advisory committee meeting reviewing the diabetes drug, Avandia. Based on an earlier article (link below), FDA Matters will be looking at how Dr. Hamburg’s FDA handles the discordant voices coming from within the agency.

Missing from public dialogue is the extraordinary (perhaps unprecedented) number of large, consequential projects that FDA will be working on this summer. Every part of FDA is involved in some initiative that could become a “game-changer” for the agency. (more…)

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“Safe”: Many Meanings Complicate FDA Policymaking

Sunday, May 23rd, 2010

FDA Matters is in favor of safe foods and safe medical products. Who isn’t? If you are a consumer, maybe that’s all that matters.

However, being in favor of safe foods and safe medical products is not enough if you are FDA, the media, Congressional authorizers and appropriators, OMB, and industry. It sounds good, but what does it really mean? In the FDA context, “safe” means many things, some of which are barely related to each other. (more…)

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FDA’s Growing Presence Outside of the Washington Beltway

Thursday, February 11th, 2010

The federal government is closed for the fourth straight day. However, it would be more accurate to say: closed in the DC area. A significant part of FDA is open and has been all week….making this a good time for FDA Matters to acknowledge and explore the growth of FDA in places far from the Washington Beltway. (more…)

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A New Food Agency Has Become Unnecessary (For Now)

Friday, January 15th, 2010

FDA Matters applauds the appointment of Mr. Michael Taylor to be the first Deputy Commissioner for Foods at FDA. With more authority, experience and stature than any previous food leader, he has the opportunity to shape and re-shape food regulation and the safety of the food supply.

Because Mr. Taylor will be outstanding in this new post, the campaign for a separate food agency will go away, at least for a couple of years. (more…)

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Has FDA Slipped Back into Anti-industry Mode?

Wednesday, January 13th, 2010

An industry CEO wrote me to observe: FDA is returning to the anti-industry paradigm of the past.  His concern is understandable. Yet, I respectfully disagreed with him. It is natural to fear change. It is easy to confuse activism with ideology.

FDA Matters believes there are two perspectives from which to judge the situation of FDA versus industry. (more…)

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Stigmatizing the Obese and Criminalizing Food

Wednesday, January 6th, 2010

Well-meaning policymakers are constantly advocating for specific solutions to societal problems. They intend to create a better world and often they do.

In the process, their good purpose is sometimes hijacked by unintended consequences. FDA Matters believes this is the inevitable fate of policies that tell Americans what foods they are allowed to eat. (more…)

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