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Senator urges pregnancy labelling overhaul

US Senator Herb Kohl, is pushing the FDA to revamp the way it handles the communication of drug risk information for pregnant and breastfeeding mothers

US Senator Herb Kohl, the Democrat from Wisconsin, is pushing the Food and Drug Administration (FDA) to revamp the way it handles the communication of drug risk information for pregnant and breastfeeding mothers.

Kohl has issued a letter to Health and Human Services Secretary Kathleen Sebelius, who has authority over the FDA, urging her to get the agency to finalise a proposal to overhaul the system for pregnancy-related labelling and risk-categorisation.

The FDA issued a draft rule in 2008 proposing to update the original system of pregnancy labeling, which was established in 1975. Under the existing system, prescription drugs and biologics are classified under one of five letter categories – A, B, C, D and X – to reflect the level of risk of birth defects and other effects on reproduction and pregnancy.

"It is widely acknowledged among advocates, doctors and even some at the FDA that the current system is confusing and leads to over-simplification," Kohl wrote in his letter to Sebelius. 

The FDA's proposed rule would eliminate the letter category system, replacing it with more detailed information in a clearer and more accessible format, including a risk summary and other information specifically intended to address the needs of pregnant and nursing women. The data could come from various sources, including from studies published in the medical literature and from pregnancy-exposure registries maintained by the companies. In addition, the labelling would specifically state when there is not information available.

However, the draft rule has never been finalised. "It is my understanding that (the draft rule) is still under initial review at the Center for Drug Evaluation and Research (CDER) where staff is reviewing approximately 73 comments it received from stakeholders in August of 2008," Kohl's letter states. "Too much time has passed."

Draft rules are open to public comment and are only finalised once the agency has reviewed and responded to the comments. The process is intended to be completed relatively quickly. 

Kohl's letter asks Sebelius to provide Congress with "a comprehensive timeline of the pregnancy labeling initiative from inception to the present," as well as a status report on the effort's current standing and an expected timeline for progress going forward.

31st January 2011

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