(Part Two) Of A Special Series on Federal Pre-emption, see Part One
An ad hoc group wants to know what you think about federal pre-emption in hopes of motivating public awareness and influence decision making this fall.
What is federal pre-emption? Injuryboard.com Part One covers some of the areas of consumer protection that are targeted by federal pre-emption - the concept that federal approval should prohibit state lawsuits challenging defective products or warnings.
The consumer versus corporation issue has the potential to impact every American, yet few hear about the issue on personality and celebrity saturated mainstream media. But debate is happening loud and furious in alternative media.
Dr. Doug Bremner puts it most colorfully this election season in his blog on the Huffington Post:
“While Americans sit mesmerized by Sarah Palin clapping into the microphone and rambling on about Greek Columns while her daughter wipes down her youngest child's hair with her own spit, they are utterly unaware of yet another attempt by the Republican machine to steal even more of their civil rights and liberties. As if the "Patriot" Act wasn't enough, the war mongerers now want to take away your civil rights in the form of redress in the event that you or your family are damaged by dangerous prescription drugs. And while the fear mongerers are hyping the "War on Drugs" and making chemical attacks against Columbian farmers, they aren't drawing attention to the fact that three times as many people die from "legal" prescription medications every year as from illegal drugs, and that the government is getting ready to remove your right to have any recourse for the harm that is done to you by a pharmaceutical company.”
Here is the petition, opposing federal pre-emption which can be signed and submitted electronically to Congress.
The group chose the web site Pharmalot, which covers the drug industry and the pre-emption issue, to post the petition on this devisive issue.
The petition states:
"Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA's regulatory actions and enhance patient safety. ...
“In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people."
The petition is the creation of “Americans for Drug and Device Accountability."
Hank Greenspan, a social ethics lecturer at the University of Michigan Medical Center says it was organized by a diverse group of people "healthcare workers, patient advocates, policy analysts, and so on (but no lawyers, if anyone cares!). Politically, we are equally divided - from conservative Republicans to liberal Democrats. It is genuinely multi-party. And no one, by the way, is “anti-industry.”
“So it is about an issue, not about an individual or even individuals. What may be “newsworthy” is that, as far as I know, this is the first such petition on preemption that arose in an entirely grass roots, spontaneous way. The effort has no ties with any other group - be that Public Citizen, AAJ, AARP, etc. It is just citizens who are deeply concerned, acting on it.”
Not to be outdone, a reader of the web site Pharmalot in response has created his own petition in support of pre-emption. It too is an iPetition and submitted to Congress electronically.
It states that:
“We the undersigned support the doctrine of pharmaceutical preemption. Congress has given the FDA authority to regulate and maintain the adequacy of domestic pharmaceuticals. State courts consisting of lay juries should not be allowed to second-guess the decisions of well-trained medical staff employed by the FDA. Doing so undermines the scientific process and potentially undermines the future development of new medications. State courts are interested in the health of the individual involved in the lawsuit. The FDA is interested in the health of the nation. Preemption is an essential guard that protects the health of the populace from being overridden by the concerns of the health of a few individuals involved in high-profile lawsuits.”
The U.S. Chamber of Commerce is known to be a big supporter of federal pre-emption and the relief it potentially offers to industries it represents, as is the Pharmaceutical Research and Manufacturers of America (PhMRA), a trade group that represents the country’s leading pharmaceutical research and biotechnology companies which reached assets of $58.8 billion in 2007, it says.
According to a June 11, statement, PhRMA Senior Vice President Ken Johnson defines the other side of federal pre-emption:
“Federal preemption is not about providing blanket immunity for America’s pharmaceutical research companies. It is about allowing the Food and Drug Administration (FDA) to do its job to protect patients by overseeing drug warnings.
“Indeed, patients are best protected by a single, strong, uniform regulatory authority that is the sole arbiter of the benefits and risks of medicines. That is why Congress empowered the FDA to approve how that information is conveyed on the medicine’s label.”
While it may not be as exciting as Palin or Paris – the federal pre-emption debate is one you might hear more about in coming weeks as the November 3rd U.S. Supreme Court revisits the issue in the upcoming Levine case.
But don't expect to hear the debate about the role of government and the rights of corporations and citizens on the mainstream media, which today on “Today” was busy with a story on a 13 pound Chihuahua, real estate bargains, “Food for your Face,” and Fashion Week, “Pumps Up the Volume”. #