There are certain regulatory agencies where it is clear from the outset that most of the agency's activity is merely aimed at protecting their own jobs and power.
The one such agency I run up against are Alcoholic Beverage Commissions in various states, from whom one must obtain a liquor license. In the type of small store we run, there are really only two things the state should care about, and even the second is a bit weak
- That we don't sell alcohol to underage kids
- That we don't allow alcohol consumption on the premises
But the liquor licensing process can be interminable. In Arizona, for example, I have had my applications kicked back to me, which resulted in 2-month delays in the process, because I wrote an address as 1313 48th Pl. rather than 1313 48th Place. They spend incredible man-hours looking for nit-picky mistakes like this, and then kick it back so that the whole review process must begin again. Many states and counties have a second layer of review, to make sure that your new competition is "needed" - after all, we wouldn't want to upset the position of incumbent businesses who are entitled to their market share and who make nice campaign contributions.
Each application has to have a drawing of the store layout and where one plans to put the beer. If you want to move the beer at a later date, you have to get the state's approval. (Bizarrely, the drawing in most states has to be by hand -- they will kick back an application with a CAD drawing or architect's drawing). And don't get me started on the fact I have to be finger-printed by the FBI (so they can be sure I am not Al Capone) before a store I own can sell beer.
All this being said -- and I didn't mean to run on so long but liquor licensing just drives me nuts -- it is nothing to this example from the pharmaceutical manufacturing business. I won't repeat it all, but take this example:
a drug manufacturer must get approval for how much of a drug it plans to produce, as well as the timeframe. If a shortage develops (because, say, the FDA shuts down a competitor’s plant), a drug manufacturer cannot increase its output of that drug without another round of approvals. Nor can it alter its timetable production (producing a shortage drug earlier than planned) without FDA approval.
They have to get their production schedules approved? What possible justification can there be for this? But even more outlandish is the apparent drive to regulate drugs that have been on the market for over 70 years and have to date been relatively unregulated because they were on the market before the FDA got its current powers. Why should a bureaucrat lose her job when there are still unregulated items out there? Besides, some uneducated American might use these examples of safe, unregulated drugs to question the who regulatory mission!
Several drug shortages (e.g., concentrated morphine sulfate solution, levothyroxine injection) have been precipitated by actual or anticipated action by the FDA as part of the Unapproved Drugs Initiative, which is designed to increase enforcement against drugs that lack FDA approval to be marketed in the United States. (These drugs are commonly called pre-1938 drugs, referring to their availability prior to passage of the Food, Drug, and Cosmetic Act of that year.) Some participants noted that the cost and complexity of completing a New Drug Application (NDA) for those unapproved drugs is a disincentive for entering or maintaining a market presence.
I have heard several medical people joke that it would be tough to get aspirin through the FDA today if it were a new drug and not grandfathered. Don't know if that is true, but it feels believable.