Drug labelling reforms still awaiting approval
06 Aug 2007Ten years after the Food and Drug Administration (FDA) recognised that new rules need to be applied to the labels of drugs for use during pregnancy; modifications have not yet been approved, according to new reports.
In 1997, a public hearing urged the FDA to revise its pregnancy labelling regulations by replacing the categories with clearer and more complete summaries of information on potential risk.
The FDA has proposed changes that would include more information, clearer description of the risks of using the medication and a discussion of considerations to be more aware of.
The likelihood of risk would be categorised as none, low, moderate, high, or unknown.
"It remains to be seen whether the criteria for each category are interpreted with sufficient flexibility to result in scientifically sound risk communication," according to the Public Affairs Committee of the Teratology Society, but it maintains that the new system offers important advantages over the old one.
The committee recommends approving the new rules and releasing them for public comment without further delay, since the FDA estimates that the new system will not become effective before 2010.
In addition, testing the new system among physicians and consumers to determine whether it is effective at communicating risk and appropriate clinical decision-making has been recommended.
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