Yesterday, the House Energy and Commerce Committee unanimously approved H.R. 4040, the Consumer Product Safety Commission Modernization Act of 2007. The bill is similar to a bill passed by the Senate Commerce Committee in October which would expand the resources and authority of the agency.

Among other things, the bill would:

• Dramatically increase the budget and staffing at CPSC and dedicate funds for improving its much-maligned testing facility;
• Require third-party testing and certification for children's products;
• Ban lead in children's products; and
• Enable CPSC to levy greater fines on delinquent manufacturers.

Both the House and Senate bills await floor consideration. Legislators had hoped to finalize the legislation by the end of the year, wanting to be seen taking positive action on children's product safety during the Christmas-shopping season.

Meanwhile, CPSC announced two more recalls of children's products due to high levels of lead. CPSC has announced 106 such recalls in 2007, totaling more than 17 million individual products. That's six times more than the number of products recalled in 2006.

Today, the Consumer Product Safety Commission announced another recall of a children's product for excess levels of lead. The grand total for 2007 is now 99 recalls totaling more than 16 million products, based on CPSC data compiled by OMB Watch. That is nearly six times more than the number of product recalled in 2006.

While a feckless and under-funded CPSC continues to struggle with its mission to ensure product safety, another group has decided to pick up CPSC's slack. Yesterday, the Ecology Center launched a new database at HealthyToys.org.

According to the site, "HealthyToys.org tested over 1,200 children's products and more than 3,000 components of those products" for a variety of chemicals, including lead.

The Ecology Center found dangerous levels of lead in 35 percent of the products it tested. The Ecology Center tested for other chemicals as well and found dangerous levels of cadmium, arsenic and mercury is some toys.

HealthyToys.org is truly filling a regulatory void. As the website says:

No government agency is adequately assuring that children's products do not contain harmful chemicals. Nor does any agency require labeling or disclosure to inform consumers about the chemical components of children's products. HealthyToys.org was launched to address the failures of our current system to regulate chemicals in products.

The New York Times has a recap of the oral arguments heard yesterday by the Supreme Court in Riegel v. Medtronic. As Reg•Watch blogged yesterday, the issue is whether federal regulation preempts state common law claims against medical device manufacturers.

In March, FDA issued draft guidelines that would revise its criteria for determining whether scientific advisory committee members have financial conflicts of interest. FDA advisory committees are standing panels comprised of individuals considered experts in a particular field. They provide advice to FDA on matters such as drug and medical device safety.

While the guidelines would be a good step toward ensuring scientific integrity on FDA panels, they would also make it too easy for FDA to grant waivers to conflicted scientists. For example, if FDA determines an individual has a financial conflict, the guidance instructs agency personnel to ask: "Does the need for the individual's services outweigh the potential for a conflict of interest?" If the answer is "yes," the member could serve on the panel but could not vote.

FDA argues that certain individuals have unique experience and qualification and, regardless of financial conflicts, are necessary for the panel. In fact, FDA recently issued a report which concluded it would be too difficult to create conflict-free advisory panels.

But a new investigation by the Center for Science in the Public Interest (CSPI) debunks that myth. CSPI analyzed the same data FDA used for its study, but came to a different conclusion:

For each of the four advisory committees analyzed in the study, it would have taken a single FDA official just one week to replace all the advisers who had conflicts of interest with experts who do not have conflicts of interest, according to CSPI's analysis of the ERG data. Moreover, the FDA would be able to choose from nearly two potential unconflicted experts for every open slot. And, based on the same criteria for the expertise of potential committee members used in the study, these easily identifiable unconflicted experts would be more qualified than the ones eventually chosen, whether they had conflicts of interest or not.

A case being argued before the Supreme Court today could affect the way consumers seek redress from companies when harmed by faulty drugs or medical devices. The case, Riegel v. Medtronic, "was brought by the family of a New York man who suffered severe medical complications when a balloon catheter burst during a procedure to clear his arteries," according to The Los Angeles Times.

Medtronic is arguing federal regulations serve as a shield which protects it from tort claims. Since FDA approved the medical device, Medtronic believes it bears no responsibility for injuries caused by its use.

As the LA Times reports, the case has broad ramifications: "The question in the catheter case is whether Congress intended to bar state common law claims when it gave the FDA authority to regulate medical devices in 1976."

In fact, Congress did legislate a regulatory system in which state regulations cannot supersede federal ones. Congress recognized 50 different sets of rules would be a nightmare for pharmaceutical and device companies seeking approval and would put consumers at greater risk.

But Medtronic is trying to compare apples and oranges. The positive law enacted by the U.S. Congress and state legislatures is different than the common law created by the courts in tort claims like this one.

The Bush administration has also been conflating these two types of law in its war on torts. A series of federal regulations have included language that preempts tort claims against companies in compliance with federal regulations. More on that here.

Update: The New York Times recaps oral arguments (12/05/2007)

Posted by Matt Madia, 10:28:54 AM