Saturday, May 26, 2007

Thursday, May 17, 2007

We Are All the Mitten State - FDA Preemption and the Lipstick Problem

Professor Henry Greenspan (Psychologist, U Mich) has posted an article on the TortDeform Blog focusing on efforts to make FDA standards preemptive. He presents reasons why FDA regulations should not pre-emption state tort actions (as Michigan law does with drug injury cases—Michigan is the Mitten state). The lipstick problem is the focus on reforming FDA as the means to resolve criticism of FDA preemption of states.

[M]ore central to the issue of FDA preemption, there remains a wide range of potential delinquencies relevant in civil litigation but over which the FDA – even in its most "revitalized" incarnation – has no authority whatsoever. Staying with Vioxx, for example, we learned that there was an orchestrated campaign to threaten and intimidate academic researchers who did not see things the company's way. Tactics like those may profoundly influence what does and does not become known about a drug's safety, but they have nothing to do with whether a company is "in compliance" with FDA regulations. They are not within the FDA's jurisdiction at all.

We have also learned that data may be skewed, even excised, in ways that impact what is published in major medical journals. These are the sources of information upon which physicians rely. Again, however, the FDA has no authority whatsoever over the editorial policies of those journals. Indeed, in a now well known article about Celebrex published in the Journal of the American Medical Association – in which, it turned out, half the data was simply left out – the most seasoned medical reviewer at the FDA, Dr. Robert Temple, noted "when the JAMA article comes out and confirms the hype, that probably has more impact than our labeling does." Unfortunately, even if we had the most "revitalized" FDA imaginable, there would remain very large arenas for potential intimidation, misinformation, and hype.

That is why there is no FDA reform conceivable – and even less what was just passed by the Senate – that would substitute for the accountability that civil liability makes possible. The two systems complement each other; they do not cover the same ground. And that is why, when the FDA preemption gang starts to invoke that bill to suggest that FDA's problems are now solved, we should not be distracted. We should not confuse the pig, when there is one, with the lipstick.

You can read the whole article at: http://www.tortdeform.com/movabletype/mt-tb.cgi/873.

Thursday, May 10, 2007

Gluten factory had a toxic history

By Don Lee and Abigail Goldman
May 9, 2007

XUZHOU, CHINA — Before Mao Lijun's business exported tainted wheat products that may have killed American pets, his factory sickened people and plants around here for years.

Farmers in this poor rural area about 400 miles northwest of Shanghai had complained to local government officials since 2004 that Mao's factory was spewing noxious fumes that made their eyes tear up and the poplar trees nearby shed their leaves prematurely. Yet no one stopped Mao's company from churning out bags of food powders and belching smoke — until one day last month when, in the middle of the night, bulldozers arrived and tore down the facility.

It wasn't authorities that finally acted: Mao himself razed the brick factory — days before the investigators from the U.S. Food and Drug Administration arrived in China on a mission to track down the source of the tainted pet food ingredients.

In the end, Chinese authorities caught up with Mao and arrested him. And Tuesday, after weeks of denials, China acknowledged that Mao's company and another Chinese business had illegally exported wheat and rice products spiked with melamine, a chemical used in making plastics and fertilizers. That chemical is banned in foods in the U.S.

For the rest of the story: http://www.latimes.com/business/la-fi-petfood9may09,1,5484365.story?ctrack=1&cset=true (requires free membership).

Monday, May 07, 2007

Food Safety Hearing

The U.S. House Committee on Agriculture will hold a hearing to review the impact of imported contaminated food and recent food safety emergencies on food safety and animal health systems, at 11:00 a.m. ET on May 9, 2007. The hearing will be held in Room 1300 of the Longworth House Office Building. For more information, visit http://agriculture.house.gov/hearings/schedule.html.

"Panel urges schools to replace junk foods"

Washington Post (04/26/07) Sally Squires

The Institute of Medicine (IOM) has released a report proposing bans on soft drinks, sugary snacks, and other junk foods sold in schools to combat obesity in children. The recommendations, drafted at the request of Congress, were the first to address the issue of “competitive foods,” snacks and drinks often sold to raise money for schools, and which compete with healthier cafeteria offerings. IOM said less-nutritious offerings should be replaced with fruits, vegetables, low-fat dairy products, and whole-grains. The recommendations also suggest that the calorie content of snacks and drinks be limited to no more than 200 per portion, and that schools switch to items that contain no trans fat, lower levels of sugar and sodium, and no more than 35 percent of calories from fat. IOM also suggests a ban on sports drinks, soft drinks, and caffeinated drinks, calling for schools to provide free, safe drinking water or allow students to buy nonfat or low-fat milk or 100 percent juice. J. Justin Wilson, of the Center for Consumer Freedom, called the recommendations “misguided,” warning that the report jeopardizes the classroom birthday party. But “Children eat 30 to 50 percent of their calories at schools on school days,” said Margo Wootan of the Center for Science in the Public Interest. “When parents send their kids to school with lunch money, they don’t want to worry that it will be spent on Cheetos and Gatorade.”

To read the text of the IOM report, Nutrition Standards for Foods in Schools: Leading the Way toward Healthier Youth, visit http://www.iom.edu/CMS/3788/30181/42502.aspx.]