Wednesday, May 28, 2008

Newly Proposed Drug Label System

USA Today reports on a newly proposed drug labeling system that will attempt to enhance information about the effects of medicines used during pregnancy and breast-feeding. The following is from the FDA's press release:

"With this proposal, FDA's goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breast-feeding infants will benefit," said Rear Admiral Sandra Kweder, M.D., Center for Drug Evaluation and Research, FDA. "This proposal would help make drug labeling a better communication tool, and would potentially have a huge impact on public health and well being for women."

The proposal would eliminate the current pregnancy categories A, B, C, D, and X and replace them with a consistent format for providing information about the risks and benefits of medicine use during pregnancy and lactation.

The USA Today article goes on to say that the FDA has been working on this labeling issue since 1997. I am in full support of this initiative yet at the same time shocked that it has taken 11 years to propose an improved process that should improve medication safety and patient outcomes. I've googled this issue and found information from April 2007 urging the FDA to take prompt action. Here we are, 13 months later still trying to sort it out. Where are the priorities? For an agency that has relaxed the rules (back in 1997) requiring pharmaceutical companies to disclose all side effects and adverse events of medications to now only a brief statement (direct to consumer advertising where companies are spending an estimated $3 billion dollars/year), it seems as if they don't have the public's best interests at stake.

If you'd like to read more on this issue, visit this link that will take you to the FDA website, "Pregnancy and Lactation Labeling."

Also, the FDA will accept electronic comments for 90 days on this proposal at In typical hard to navigate fashion, I cannot locate the proposal on that website in order to submit a comment. I will check back and provide an update when its available. I believe healthcare professionals and patients alike should strongly support this proposal. When can we expect this to go into effect? Here is the FAQ from the FDA website:

"The version of the rule being published today is only a proposal. FDA expects to receive numerous comments on the proposed rule, and those comments will need to be considered carefully before we publish a final rule. This process will take some time."

How many more medication errors and complications must occur before this archaic system is updated? What are we waiting for?!?

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