FDA To Change The Way Drugs Are Approved

From the Washington Post:

The Food and Drug Administration said yesterday that it is making changes in the way it operates to prevent the kind of drug safety controversies that have dogged the agency in recent years.

Officials outlined plans to better monitor safety problems after drugs are approved and to make internal changes to increase the profile of agency scientists who raise red flags about drugs. The steps were announced in response to a report last year by the congressionally chartered Institute of Medicine (IOM) that called for an overhaul of the FDA’s culture and structure following safety controversies over drugs such as the painkiller Vioxx.

While the changes seem like a good start, the FDA still does not have the power to “impose fines and restrictions on companies that do not voluntarily follow the FDA’s directives,” and that is of some concern to consumer advocates. —MEGHANN MARCO

FDA Revamps Process for Safety of Drugs After Approval
[Washington Post]


Edit Your Comment

  1. SexCpotatoes says:

    ooo, so anyone who raises red flags for a medication after it is released, gets a raise or is promoted? I want that job!

  2. More likely, they just have some way of getting the attention of the people who are supposed to be watching for such things.

    However, I’m not too comforted by the “overhaul”. Seems that they’ve been told to communicate better with each other in their battle to, um, wag their fingers in the case of wrongdoing.

    What’s the FDA’s mission statement exactly? “To gently suggest that drug companies not kill people for profit”?

  3. Mr. Gunn says:

    You may not want to give a group like the FDA too much actual power. They’re already known for being a little heavy-handed to certain segments, such as supplement manufacturers, while giving huge food and drug conglomerates a free pass. Giving them the ability to levy fines wouldn’t do anything to change who they focus their attention on.

    As a case in point, they were successful at getting ephedra outlawed while people taking Vioxx were dropping like flies. Giving the FDA fine-levying ability wouldn’t have changed a damn thing. The FDA should focus on studying the health risks of foods and drugs, and let the legislators handle enforcement.

  4. Tonguetied says:

    My problem with the FDA is the exact opposite of what is being ‘fixed’ here. I think the bureaucracy is so cumbersome and difficult to get through that there are thousands of people suffering and dying because they don’t have access to new drugs.

    It’s always easy to point out who dies from a bad drug, it’s a lot harder to pick out the ones who died because there wasn’t a drug available.