Thursday, November 24, 2011

Government Over Reach- The Food and Drug Administration

Last night I stumbled across a radio clip of a lawyer who was fighting the Food and Drug Administration. It seems the government, the FDA, has now decided that it is in the business of regulating mobile software applications that are being developed and used by doctors.

The lawyer on the radio clip was talking about a specialized physician who had developed a software application with a bunch of lengthy mathematical calculations. He would input a specific patient's data. He was using the software to determine the dimensions of cancerous breast tissue, triangulate the dimensions, and then bombard it with the appropriate amount of radiation. He was doing this to prevent over or under dosing- to deliver the appropriate amount of radiation. The doctor's software saved time and was safe. It had the proper calculations pre loaded and prevented math errors.

The FDA told him to quit using the software and that he could not sell it. This of course is what government does best. It interferes in places it has no business in nor was the FDA designed to regulate software applications.

Now I don't know how the FDA has usurped that responsibility but they have. Take a look at this statement from the FDA's website. Specifically paragraph 4. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/ucm255978.htm

The FDA claims it has the responsibility to oversee software applications if they do not work as intended. Wow. Why doesn't the FDA just say it is their responsibility to oversee every physician in the United States to make sure they work as intended?

Here is a copy of the FDA's mission statement in 2003:

"The FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. Our work is a blending of law and science aimed at protecting consumers." 

I wasn't able to find a place in that mission statement wherein the FDA could claim that they are now in the software regulating business but apparently they have decided to do just that. Researching online- I found several articles on this- some pro and some con. It appears that this latest over reach occurred last summer. Here's kind of a non-biased report. http://news.cnet.com/8301-13578_3-20081086-38/fda-seeking-to-regulate-mobile-medical-apps/


This is a perfect illustration of how a seemingly harmless event turns into a bureaucratic nightmare. The FDA's original proposal seems well intended. So people give it a nod. Nobody stops to think- well just who are they going to target? What apps are they going to pick and choose to regulate? Are they going to literally try and manage the thousands of applications that will crop up? Are they going to go to court over every one? To me, this is like opening Pandora's box. Everyone suffers and patients who would receive the best and most accurate care will be denied that care while the FDA screws with software applications. And it doesn't really have a damn thing to do with why we invented the FDA in the first place. Of course now- that becomes the argument. 

What we are really talking about is a government that has decided to try and micro manage it's citizens and enlarge the scope of it's operations. This is what I call the anti- Covey...lose...lose...lose scenario. Software developers suffer. Doctors and patients suffer. The tax payers suffer. All of this occurs because somebody is afraid to put their foot down and tell the FDA "no." Of course the central planning statists think this is a good idea. They always think more government is a good idea. Just as long as someone else pays for it.

2 comments:

brian said...

I've got my own problems with the fda. A company called striker makes a product called the power lift. Picks up the cot and the patient and you just push the cot into the ambulance. We've been waiting for months and the fda keeps dragging their feet. My old fireman back just can't take much more. I hate the fda. This product is neither a food nor a drug. On a side note happy thanksgiving brian! We are blessed that people like you get on the net and blurt the truth!

Brian said...

I know stryker well.

Government moves at a glacial pace. And don't believe them Brian- they aren't overworked. But they have a manual somewhere that says tell everybody you are overworked when in fact- you don't do much at all.

I used to have that manual.

Brian