Teratology public affairs committee position paper: Pregnancy labeling for prescription drugs: Ten years later
✍ Scribed by Public Affairs Committee of the Teratology Society
- Publisher
- John Wiley and Sons
- Year
- 2007
- Tongue
- English
- Weight
- 54 KB
- Volume
- 79
- Category
- Article
- ISSN
- 1542-0752
No coin nor oath required. For personal study only.
✦ Synopsis
September 12, 2007 marks the tenth anniversary of a public hearing that was hoped to be the death knell of the pregnancy labeling categories for pharmaceuticals, the A, B, C, D, X system of designations that was put in place by the US Food and Drug Administration (FDA) in 1979 (US FDA, 1979). The replacement of the pregnancy labeling categories had been sought by the Public Affairs Committee of the Teratology Society, and the public hearing that was believed to herald the impending demise of the system in 1997 was seen as an important public health advance. On this tenth anniversary, the system remains in place, although some progress has been made in replacing it. We examine here the history of and rationale behind the effort to change the pregnancy label and the current status of proposed new labeling, and we offer recommendations for the future.