New Law Gives FDA More Control
I just read an article that was posted on medtrackalert.com, written by David Stanley, a community pharmacist for 15 years. The article points out that the Food and Drug Administration has responsibility for reviewing the safety of medications, but what will surprise most people is that until this year, there was never a requirement that a drug ever be studied again once it was approved for the market. This meant that the FDA had no way to address the safety concerns of medications or medical devices except to pull the product off the market.
Congress recently passed the Food and Drug Administration Amendments Act of 2007. The new law gives the FDA the ability to order manufacturers to do post-approval clinical trials and to penalize them if they don’t follow through.
The FDA now has the authority to order changes in drug labeling so that doctors and the public will be informed sooner of potential risk factors.
The act will also establish an Internet database with information from all clinical trials that will be administered by the National Institute of Health. This database will be open to both researchers and the general public.
I have personal concern with the NIH data base. It is a fact that there are a zillion clinical trials that have been funded by manufacturers. The outcomes are often biased in favor of the manufacturers’ products. My fear is that this information might give the public a false sense of security when it comes to particular drugs and medical devices.
That being said, hopefully this new act will be a step towards getting the FDA back on track to protecting the consumer. SAFETY FIRST, before they put the FDA stamp of approval on a product!
Pam, this is very interesting news. Does this mean that the FDA now has the power to enforce the clinical-trial requirement that was a condition for allowing silicone breast implants back on the market? The manufacturers have always dragged their feet about doing the research to demonstrate once and for all the risks of implants over the long-term. They’ve either done a shoddy job or just not bothered to collect the information because they knew no one would or could do anything about it.
As for the database, I think it’s definitely a good thing. Making such information public means that there are more eyes to scrutinize, and more cues as to what people should be keeping an eye out for. I bet that over time, there will be people (ex-FDA staffers, scientists) and organizations (Consumer’s Union, the National Research Center for Women and Families) that will begin to routinely explain and interpret the latest info for the public and the mainstream media.
Comment by Gloria — November 20, 2007 @ 6:37 pm
This is great news on the drug front, but it is unfortunate that they did not make the same regulations for devices. Currently, the FDA does not have the authority to regulate the post approval studies that they required of the breast implant manufacturers. Congress did a great job with drug safety and enforcement, but now it is time for them to do something about the device division!
Comment by Amy — November 21, 2007 @ 1:23 pm