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April 8, 2008, 3:50 pm
Flag as Inappropriate ewills  

A few weeks ago I remember reading a post from fellow eDrugSearch member Tom that posed the question if patients should be allowed to file drug industry lawsuits. (Here’s the Post /hot-topics-food-and-drug-administration/should-patients-be-allowed-to-file-drug-injury-lawsuits-125)

The resounding response from other members was yes, simply because the FDA has neither the means nor the will to be completely infallible in the drug approval process.

The NY times spoke of another case in an article today involving Johnson & Johnson:

"For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted."

If this pre-emption clause is passed, who will be there to hold the pharma companies accountable? Very scary.

This is ridiculous. So the FDA, the agency that is funded by big pharma, the agency that on numerous times has displayed its complacency and lack of aptitude in governing the approval process of prescription meds, is going to keep the drug companies honest. It must be getting chilly in hell.

Like I have said before, The drug companies must be held accountable by the public because the FDA is not and cannot do their job.

Obviously, our beloved president is pushing this stupid argument. What a travesty.

This really is stupid. The FDA is frequently staffed by the very people who hold patents to the drugs that they then approve. Dr Paul Offit anyone?

They have a huge motivation to pass things that shouldn't be passed. Until the agency approving and testing for safety drugs that are approved for use is completely without hidden agenda and is profitless and has no connection to pharma, then this is a dangerous move.

For what it's worth, this is one of the things that has been a big concern surround vaccines for children for many years and now its only when the issue is finally affecting adults that attention is paid. Why is that?

How can such injustices continue going on and on? If a person is made ill, or eve worse by a pill that has an incorrect label too, then there should be no reason not to put the question of liability onto the shoulders of a jury. If they think that there's nothing to the case then so be it. It's like bad fiction to permit drug companies to wash their hands of all responsibility.

But I guess it's all a part of the same bad fiction that drug companies can charge hundreds of times over the cost of a pill. That the same drug labeled for an animal will cost pennies when it costs dollars for a human. That an inexpensive drug that can save millions of lives isn't sold at a reduced cost to poor people and countries who need it.

This has to be corrected. What can we do?

This is truly interesting considering the number of drugs the FDA has approved that have turned out to have considerable life threatening side effects. I'm curious to know how much lobbying money goes to the FDA to get them to approve drugs faster for consumer use. It used to take 10 years or more for a drug to tested and approved. I may be wrong but it appears as if it takes less time and testing to obtain drug approval.