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Why does FDA approval matter?

Talking about the US right now, obviously...

I wanted to write a quick, pat post about what FDA approval means and the effects it has on the use of medical devices (such as lap bands) and drugs.

I had a few points in mind:

  • The FDA can take action to stop the sale of unapproved drugs and medical devices. However, drugs and devices that are approved for a particular group of patients or for a particular use may be prescribed "off label" by licensed physicians. That's why lap bands and similar devices are already being used in teenagers.
  • However, FDA approval makes it much more likely that insurance companies will cover a particular treatment AND
  • FDA approval will tend to decrease doctors', drug companies' and insurance companies' liability. In other words, when the FDA approves a drug or medical device, it is taking on some responsibility for its effectiveness and safety.

Those issues seemed pretty clear to me, based on my limited knowledge. However, I wanted to confirm them and to find out when an unapproved treatment might invite government legal action against a manufacturer, retailer, or practitioner. I hoped that this would involve half an hour of online research. Oh, how wrong I was.

Like a lot of government agencies, the way the FDA does its job is not always well documented and well defined. I'm not saying that they do a bad job, although many people agree that they're too much under the influence of drug industry stakeholders. It's the nature of government that the laws and regulations that assign responsibility aren't always clear or consistent, and the scope of action is dependent on limited resources.

Since I don't want to wait to post this until I've had time to research and write the equivalent of a university term paper, I'm going to post a few links and ask BFB commentators to add their insights.

  • This post on the web site of the American Cancer Society is the most concise, straightforward, and comprehensive discussion of off-label use I've found.
  • Here's a post on off-label use on the website of a doctors' liability insurance company.
  • This John Hopkins Health Alert discusses how FDA approval can actually help to identify unsafe drugs and devices by requiring the collection of data on their effects. This article mentions the Medwatch System, which I think merits a post of its own. For now, I'll just say If you've had side effects or experienced the failure of an FDA-approved drug, device, or system, then report it!
  • It seems that the question of liability in the event of harm caused by FDA-approved drugs and devices is a hot one. This article, from a doctor's point of view, is in favor of more a rigorous approval process at the FDA and less liability for doctors. Key quote: "FDA approval now immunizes medical-device manufacturers from state tort liability. As a result, plaintiffs will target physicians, hospitals, and health care systems."
  • This, more recent article suggests that drug companies and device manufacturers are still liable.

Help me out! Any corrections or clarifications to what I said above, things to add, or new sources of information? Any thoughts based on this?

Lonie McMichael: The Sisyphean Bind | Pattie Thomas in 'Psychology Today'

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