There is a fierce debate going on in the legal community. The issue is whether or not consumers retain the right to sue a pharmaceutical company for failing to warn about a side effect. The FDA and Big Pharma argue that the FDA is fully informed of the potential side effects when approving the drug. This is a ill conceived policy looking to undercut the growing number of lawsuits against Big Pharma. Ask yourself if this policy makes sense in light of the following facts:
1. The FDA does not conduct any of its own studies. The FDA relies on the results and analysis of the data from pharmaceutical companies.
2. Big Pharma companies do not always release the results of clinical trials to the scientific community. Pharmaceutical companies regularly publish the results of their clinical studies in peer reviewed journals. The issue is that the companies do not always publish all the studies. In fact, pharma companies usually publish only the studies that are most favorable for their product.
3. The FDA is terribly understaffed and underfunded. The FDA cannot review every single piece of data that comes through the door. In fact, the Institute of Medicine released a study in 2006 saying just this.
There is plenty of opportunity in our current drug approval system to allow unscrupulous companies to take advantage of an overtaxed, understaffed and underfunded agency. In fact, the U.S. Government Accountability Office recently released a study lambasting the FDA for its ineffectiveness in judging whether a prescription drug is safe and efficacious.
Now, Big Pharma is engaging in a campaign to prevent consumers injured by pharmaceuticals from bringing a lawsuit against them.
Does this make sense in light of the facts?