“Too Much FDA Intervention Equals Too Few Drugs”

by Walter Olson on June 24, 2011

Bloomberg columnist Ramesh Ponnuru tackles the pharmaceutical-shortage issue covered recently in this space.

P.S. Although it is only indirectly related to the issue of manufacturing shortages, note also the interesting reader comment on the gout drug Colchicine, known and used for millennia. Per relatively recent FDA rules, colchinine and various other older drugs, formerly “grandfathered” and free for anyone to produce, have been awarded in exclusivity to a single manufacturer, at considerable cost to consumers.

{ 5 comments }

1 DensityDuck 06.24.11 at 2:16 pm

The colchicine issue has been discussed before. The problem is that the FDA is in a Catch-22 of its own making; they want to ensure that anything sold with a pharmaceutical effect is tested and verified to be safe, but the process they’ve established for that testing and verifying is horrendously expensive. They offer these exclusivity regulations as a way of allowing manufacturers to recoup the expense of creating an FDA-certified process for making and delivering the drug.

2 Smart Dude 06.24.11 at 6:43 pm

The FDA and its incompetent hyper-regulation is a massive public health hazard.

Like many corrupt federal agencies, it needs to be downsized or eliminated. Instead we have ObamaCare which puts these lunatics on steroids.

It is insane to put our health care in the hands of the same people who the run the IRS and the Post Office.

3 James 06.26.11 at 2:04 am

Dear “Smart Dude”: I live in England. In our hyper-regulated health care system here, I pay GBP 6 I think it is for a prescription. ANY prescription. The vast, vast, vast, vast majority of people here are thrilled with the NHS, and those that aren’t can buy BUPA or similar insurance at a price that is very competitive since there is an, and try to follow here, PUBLIC OPTION. There is no AMA that blocks foreign medical graduates from practicing nor artificially limits the number of medical school places. Our health outcomes are much, much, much better than that of the USA. Businesses don’t have to deal with the headaches of the bizarro world that is purchasing health insurance for employees, and employees don’t have to worry about what will happen to their health if they lose their jobs. Essentially nobody goes bankrupt here because they are ill; instead, they get treatment. And, to top it all off, when you add up all the costs, we pay far less than you do. The arguments for an NHS-like system in the USA are so persuasive, that it requires no exaggeration to conclude that people who are fundamentally against it are either have a financial stake in the current idiotic US system or are simply morons. Which are you?

4 William nuesslein 06.26.11 at 9:43 am

Smart Dude above is absolutely right. His comment begs the question as to why are FDA guys (judges and prosecutors, too) so incompetent. There is an almost universal belief that screening and inspections work better than they do. A woman on the radio claims her life was saved by a mammogram at age 46. If I remember the data correctly, somewhat less than 1/2 of breast cancers lead to death. CPSIA literally bans bicycles for children because of the brass in air values.

Somehow Ralph Nader became a folk hero in protecting consumers from profit hungry corporations. If one looks at what he actually did, scumbag would be a better applicative. His accolade, Dr. Wolfe, scared people and bankrupted companies with the horrible Breast Implant nonsense. Then our congress foolishly acted on the nonsense of another Nader guy with their crazy Toyota hearings.

Naderism is truly evil. It saddens me that our president, educated at our best universities, is a foolish Naderite.

5 Smart Dude 06.26.11 at 1:00 pm

There is not a day that goes by the the British newspapers do not have horror stories about the National Health Service. “James” is wrong on each of his points.

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