Freemarket asks a good question: Is the Food and Drug Administration (FDA) "good for us?" Freemarket prefaces his question with the following commentary:
When the FDA makes a mistake, one of two things will happen. Either a drug that is harmful will be approved, or a drug that is beneficial will be delayed or unapproved for use. Both of these mistakes will cost lives, but which would the FDA be more fearful of? Surely litigation and sullied reputation would be strong incentives for the FDA not to approve a drug that hurts people, but these same fears of litigation and embarrassment impact the behaviors of the drug companies as well. For this type of mistake, I doubt that the FDA adds much to the protections already in place by the legal system and the market. However, when the FDA delays or rejects a drug that is beneficial or the regulations of the FDA makes drug research so expensive that rare diseases are not worked on by drug companies, who bears the cost of this mistake, and who even knows about it? The sick who could have been helped have no knowledge of the harm caused to them by the FDA.I respectfully dissent Freemarket. First, Freemarket assumes that the legal system and marketplace will both work to ensure a supply of safe and effective drugs. In theory, that is correct. However, there is no real world evidence to support this theory. On the other hand, the state of affairs that existed before the creation of the FDA is proof positive that the legal system and "freemarket" were insufficient to protect consumers (and legitimate business people too, who had to compete with the corner cutters too). I've been working in the legal profession and in goverment(s) for over 20 years now, and I would trust Government Bureaucrats over the legal system any day to protect my safety. (In my opinion, Government bureaucrats are unfairly maligned). Since safety is an externality, it can't be trusted to the "freemarket." (The quotation marks are used to indicate my doubt that truly free markets exist often in the real world, rather than any personal distrust of our newest blogger). Who would you rather have judge the merits and safety of a drug: a jury of twelve people off the street or pharmaceutical experts? Did the legal system stop the marketing of tobacco and asbestos?
Second, no drug is completely safe and completely effective. What is important is that any drug's side effects are well understood and that their effectiveness is throughly tested before being placed in the market place. And its important that there be a unbiased referee to make these judgments in an impartial, objective and fair manner. One of the reasons the question posed by Freemarket is a good one, is that the FDA no longer functions as originally intended, its become over politicized and a pawn of the Pharmaceutical Industry.
Its actually pretty rare that the FDA rejects a drug thats been submitted by the pharmaceutical industry (most of the bad drugs are dropped by the companies who don't want to waste money and potential liability on drugs that have a long shot at FDA approval).
It rankles me to read the line about FDA approval costs causing the lack of drugs for rare diseases. Are you aware that the Pharmaceutical Industry is the most profitable major (legal) industry out there? Whats wrong with requiring a drug to be throughly tested before its marketed? Could the fact that rare diseases don't get the needed research be that the potential market is so small? Could it be that this is just one more example of why the free market can't be trusted to do everything?
And can you name a single drug that has been pulled from the market, by the FDA, because of a single death?
I'm not saying that the FDA is perfect or even operating in an acceptable manner. I do think that the United States needs to have a fair and effective program regulating the safety of pharmaceuticals.