Personal Injury Law

Federal Preemption: It's about mugs, drugs, bugs and thugs.

By Steve Lombardi

The Thugs who get rich or who get campaign contributions: The White House has no plan on how it would strengthen regulatory control over the FDA approval process; a process that sees junk science produced by pharmaceutical company's whose interests lean towards seeing billion dollar drugs get to market. These are the same drugs, with a few undisclosed or undiscovered kinks, that patients take increasing their risks of heart attack and liver damage.

The drugs have a few hidden bugs:

FDA internal memos point out that federal preemption that excludes patients from suing drug company's is a bad idea and will undercut valuable patient protections that presently exist.

Two officials said in the memos it is wrong to assume that FDA-approved drug labels are completely reliable, or that they are based on full disclosure of safety risks by drug makers.

"[M]uch of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis," wrote John Jenkins, the top official in the drug approval section, in 2003.

FDA officials see this as a bad president that will result in more defective drugs and drug warnings, not fewer.

In another memo that year, the associate director of the FDA's division for drug evaluation and research, Jane Axelrad, objected to the idea that companies would put too much safety information on the label if they weren't controlled by the FDA.

"We rarely find ourselves in situations where sponsors want to disclose more risk information than we think is necessary. To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information," she added.

She said the rule then under debate "is not, as it purports to be, consistent with the agency's role in protecting the public health."

The lugs who get mugged: Patients need not worry about federal preemption so long as they take complete control over their health care decisions, read every drug label, read every package insert, read the Physician's Desk Reference, subscribe to the latest research results with every pharmaceutical company that manufactures the drugs they take and asks the prescribing doctor about any questions they may have. You'd also need to carry disability insurance, hospital coverage, medical insurance with no limits of coverage, nursing home insurance, assisted living insurance, catastrophic insurance coverage, extended stay insurance coverage, home health care coverage, long and short term disability insurance and life insurance. You'll need to be familiar with all words, phrases and provisions of every type of insurance policy you own and know what way your Supreme Court will rule if the insurance company denies your claim. And if you can do all of that, then I’ve got a place on my staff just for you.

If you do that preemption probably shouldn't be on your mind.

Now on the other hand, if you don't have that kind of time and knowledge and you're taking your Rx then you'd better hope your doctor did all of that for you. And if he/she didn't then get in line with the rest of us lab rats who form the testing crew for the pharmaceutical industry. Under federal preemption we are all in one big laboratory where they experiment on us without accountability to you and I. After all what rights do lab rats have anyway?

Full post as published by Des Moines Personal Injury Lawyer on October 31, 2008 (boomark / email).