by Paul S
My article is about the FDA seeking a broader range of use for a cancer drug. When federal drug regulators approve a drug for sale they limit how the medicine can be sold. However, the FDA wants to change this because this particular drug which is being used by breast cancer patients could also be helpful in treating lung cancer patients as well but because of these regulations it can’t be sold to them. The FDA is purposing guidelines that would change all of this. The rules would allow drug and device makers to provide doctors with copies of medical journal articles that discuss product uses that have not been vetted or approved by the FDA. The rules also say that drug companies do not have to promise to do adequate testing of the unapproved use discussed in the article. I agree with these changes because the FDA usually takes a long time to approve drugs and their uses while they could being used to treat patients. This will also take the limit off of how certain drugs are sold so if they can help different illness they can be sold to the patients of those illnesses instead of just one or the other.
New FDA guidelines
Posted by: biologyblog | February 22, 2008 | 2 Comments |Responses - Create a free edublog to get your own comment avatar (and more!)
Personally, this article introduces a ruling that would have a significant influence on my life. I am a marketing assistant/intern at a medical device company that is constantly under the scrutiny and restrictions of the FDA. Our device is FDA approved to treat tinnitus, the ringing in the ears caused by hearing loss. However, our personal studies and experience allude to the fact that our device also treats other disorders such as meriners disease and hyperacusis. Unfortunately, because of the boundaries set by our FDA clearance, even if patients ask us about the device’s effect on these disorders we can not legally admit to anything. This is unfortunate because being able to treat people for these diseases, as well as tinnitus, would not only increase the demand for our product but it would also help improve lives.
By: Katie Kleinschuster on February 28, 2008
at 9:04 pm
Wow it must be really hard to know that a product that you are working with can be used to help better someone’s live but that you are unable to treat them with it because the FDA restricts it. I agree that they should allow the treatment to help as many patients and disorders as it can, it should not be restricted.
By: Amalia on March 6, 2008
at 6:54 pm
