Personal Injury Law

The FDA, part 4 (The last part, I swear)

By Amber Wheat

Despite all my research, the FDA is still one big mystery to me. I think I would understand more about what they protect us from if the public had access to information about drugs and products that have been rejected by the FDA. But giving out that information could violate intellectual property rights, damage reputations, and tip off competitors.

With the technology we have now it is easier than ever to learn about new and upcoming ideas in food and health. According to the FDA website, another duty of the FDA is to speed innovations that will make food more nutritious, make drugs more effective, and make everything more safe.

It must be a hard balance to maintain. On one hand the FDA must protect people from potentially harmful products, but they must also allow for experimentation, invention, and risk if we are to see progress.

But what do they actually DO?

The FDA regulates biologicals, cosmetics, drugs, foods (not meat and poultry), bottled water, medical devices, radiation-emitting electronic products, and veterinary products. For the most part food must be labeled correctly and safe (same with cosmetics). Drugs must be approved before being marketed (meaning they are effective and the risks do not far outweigh the benefits), labeled correctly, and manufactured in an approved plant.

Radiation-emitting electronic products must perform within FDA devised standards. Biological products must also take FDA standard into account, licensing is required (a very good thing since it involves the safety of the nation's blood supply).

What does the FDA NOT do?

They do not regulate advertising, alcohol, consumer products (my good friends at the Consumer Product Safety Commission do that), illegal drugs with no approved medical use, health insurance, meat and poultry, pesticides, restaurants/grocery stores, or water (except bottled water, the FDA makes sure it's labeled correctly).

So what happens if someone doesn't follow the FDA's rules?

If the product is really dangerous, a recall will be issued. There are fines that companies must pay. Inspectors can be disqualified and if the company is really bad they will debar them. Debarment bans a company from being in the drug business because of multiple violations.

I don't know about you, but it seems to me like they get off pretty light. I know that the FDA is supposed to not curtail invention and new innovations, but companies who don't play by the rules need to be held responsible for damages incurred by the public.

At least, that's how I feel. I am glad I got to know more about the FDA, but I am a little disheartened by what I have learned. I am also hopeful that the recent spotlight on the FDA will bring some improvement to the program.

You know, communication is really key. People like to be in the loop and I think that is where our relationship with the FDA is lacking. The FDA needs to have a more public persona telling the citizens that they are out there in the world and that they take our safety seriously. And we need to talk back to them. We should tell the FDA what we are most concerned about and what we need.

No matter how hard the FDA works, we will not be safe if we don't take responsibility for ourselves and the people who rely on us.

Full post as published by Sacramento Personal Injury Lawyer on September 27, 2008 (boomark / email).