Abbott Laboratories is being forced to “contribute” $1.6 billion to Federal and State debt because Abbott marketed its drug Depakote to its customers for uses other than those that the incompetent overlords at the FDA deemed fit. As far as I can tell—and please feel free to email me if you know otherwise—there do not seem to be any consumer complaints about being harmed by using the drug for the “unapproved” purposes that Abbott Laboratories suggested. The case was brought to the attention of our Big Daddy government by whistleblowers.
UPDATE: Don Cooper writes:
“I worked at Abbott Point of Care in Princeton NJ for a while. They produce the i-STAT blood analyzer there. They told me horror stories of continued FDA harassment for products that they had been producing for years w/o one single harmful incident due to their product. These stories are a good example of how the FDA, and other gov’t agencies, cost manufacturers and end users hundreds millions of dollars every year to address a problem that doesn’t exist. Just abusive, irresponsible and criminal.”
An LRC reader writes:
I thought that this was very interesting, as I recruit for [ ]. They are also a clinical research organization, and I have heard from clinical researchers, medical writers, and managers about the extreme grief and nightmares that they receive from the FDA. Some of them think it’s a racket, some of them think that ther rules are just too convoluted. It takes about 10-12 years of research through pre-clinical to Phase IV post marketing to get a drug to the point that it can be submitted for approval to the FDA. You would not believe that thousands of useful drugs that do not make the cut for very stupid resaons. Then to market the drug for a different indication is another couple years of trials.
I am of the opinion that, since prescription drugs have a worse track record than illegal drugs, maybe if we had the freedom to choose whatever drug we put into our bodies, the research companies would not only give us a larger pool of options at a lower cost because of competition, they would also be very careful with the quality of their drugs. I have spoken to so many people that take much pride in their research and would be horrified if people died using the drug they recommended. These employees of CROs and Pharma companies are not all greedy losers, they truly want to help cure and alleviate pain, many of them go into the field because of personal grief with illnesses. We need to cut the government perks higher up, and let the companies sink or swim on their own. There is no reason why there can’t be a private rating company and ability for people injured to recoup costs and damage privately and in civil court.10:53 pm on May 7, 2012 Email David Kramer