Quote Originally Posted by DuncanONeil View Post
How about the FDA process being voluntary rather than mandatory?
Then it is an issue of personal choice as to whether you choose to be safe of choose to take a chance on a medicine that may help. As it is an informed choice there is little to no liability for the provider.

Drugs that are in use in nearly every country but here are prohibited for use by even terminal patients because of not being "approved" by the FDA. In spite of the level of positive outcomes by patients that have used the medicine or procedure! Is it fair for the FDA to condemn these people to death just because ALL of their hoops have not been cleared?
If you have done no testing of the risks of the product you aren't able to produce the information that would allow an individual to make an informed choice. This would be comparable to making an "informed choice" about cigarette smoking in the 1920's. No one knew much if anything about the health effects so in fact people were making an uninformed choice. In the 1920's people would look at you like you were crazy if you said smoking had negative health effects.

The fact that smokers have won major lawsuits in the states suggests that drug companies would lose similar lawsuits if they don't carry out due diligence on their medications. Having a national standard does a lot to create a higher burden of proof for liability cases.

As for drugs that are in use in nearly every country these statistics can be misleading. For some drugs "nearly every country" means about 60% of the countries on Earth, keeping in mind a sizable portion have very lax standards (much of Africa for instance). In other cases, there are specific health risks that the government raises concerns about, often legitimately. Canada has had a similar situation where there were a few drugs that were approved in a lot of other countries. Some of them were involved in later problems, including voluntary withdrawals by the company and some legal issues.

Regarding legal immunity, I would point to Merck's Vioxx. Where the FDA decided what the drug did was so important they were willing to offer it protection from lawsuits on the basis of this condition and permission to continue providing it. The company decided the fact that people with a certain genetic condition would die from taking it, and no test existed for this genetic condition would do so much damage to its brand that even under these conditions it would not continue offering the drug.

Drug testing standards also limit the damage done by executives who look for short term profits increasing bonuses, at the expense of the long term health of the company. I strongly suspect at least some CEOs that needed to boost profit numbers or face losing their job would be inclined to take a risk on accelerating a drug to market, and possibly cut corners on tests if they weren't held to strict standards. It doesn't have to be every CEO or even most of them. But if even 1 in every 20 CEO's in this situation would do this then you'd be faced with huge problems.

On the other hand if the drug companies kill off a lot of people with shoddy products, people will be too scared to take medicines and health care costs will go down. I guess there is a plus side to everything. Nonetheless I ask you to forgive me for looking at the lead lining.