Regulatory Focus™ > News Articles > FDA Plans to Review REMS, ETASU Strategies for Teratogenic Products

FDA Plans to Review REMS, ETASU Strategies for Teratogenic Products

Posted 24 October 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration's (FDA) Drug Safety and Risk Management Advisory Committee (DSaRM) is preparing to meet in December to discuss risk management strategies for teratogenic products.

Teratogens are most commonly pharmaceutical products which, when taken by a pregnant woman, can cause birth defects or other developmental abnormalities. One of the most notorious teratogens is Thalidomide, a drug used briefly in the 1950s and 60s to treat the effects of morning sickness. While the drug was never approved at the time for use in the US, it was eventually linked to horrific birth defects that left many of its victims dead or disfigured.

Though some teratogenic drugs-including Thalidomide-have since been approved by FDA for other uses, their use has been tightly controlled by Risk Evaluation and Mitigation Strategies (REMS), and in particular Elements to Assure Safe Use (ETASU)--a type of REMS. REMS are meant to ensure only patients who need to use the drug have access to it, and that they are well-informed on how to administer the product.

DSaRM's meeting is meant to discuss the "various strategies" used by FDA to address teratogenic risk and how effective those strategies are at mitigating risk.

The advisory committee also plans to discuss whether the strategies are, "unduly burdensome to patient access to the drug, and to the extent practicable, minimize the burden to the health care delivery system."

Most REMS or ETASU plans include required contraception and pregnancy testing to ensure that no risks are assumed by an unborn fetus. FDA said its DSaRM will, "Discuss considerations for standardizing recommendations for use of these two tools."

The meeting will be held on 12-13 December at FDA's White Oak Campus in Silver Spring, Maryland.


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