Another New Call for Major FDA Reform Posted by Earl Lui at 10/10/06 05:39 PM

An article just published in the Archives of Internal Medicine echoes the growing consensus of physicians and other experts calling for major FDA reform. The article, entitled “The FDA and Drug Safety, A Proposal for Sweeping Change,” states the problem bluntly:

New drugs are introduced on the market with inadequate safety documentation, serious [incidents of adverse reactions] are reported from the marketplace, and a large number of patients are injured before the drugs are withdrawn or better managed.

Like the blue-ribbon Institute of Medicine’s scathing report on the FDA, the authors of this article, who are current or past members of the FDA’s Drug Safety and Risk Management Advisory Committee, recommend sweeping changes. Some of their suggestions include:

- Allowing the FDA to require more safety studies on a drug before it is approved;

- Letting FDA order drug companies to let consumers know about safety problems via prominent changes to medication labels;

- Making sure drug companies keep doing safety studies on drugs even after they are approved;

- Establishing a new office of drug safety within the FDA that would be separate and independent from the FDA section that approves new drugs.

The article ends by urging Congress to take action now. We’ll see if Congress is listening to this growing chorus for reform.

comments (2)

1 Posted by Florence at 11/01/06 02:47 PM

Like Congress will listen to us! We don't have the money or the power.

2 Posted by Bob at 11/01/06 03:14 PM

As a physician overall I agree. However, part of the reforms need to permit expanded "compassionate use." Compassionate use today by drug companies has many restrictions. This approach is meant to allow patients access with certain diseases, usually cancer, to drugs prior to the time FDA issues full approval. The rules are set by the drug company and usually are setup so there is no chance the drug will look bad.

Patients need to be able, with physicians, to decide when the risk of a new drug in a life threatening situation is worth the chance of unknown complications. Too many people die waiting for drugs to clear a cumbersome process months after the safety data is known.