FDA to Address Drug Safety

April 16, 2010

Three years after the FDA’s authority was broadened to allow it to require pharmaceutical manufacturers to conduct additional clinical studies or change medication labels (among other new powers), the FDA still has concerns about medication risks. Drug safety has always been an issue for the FDA, but given the recent high-profile troubles with the recalled painkiller Vioxx (rofecoxib), the contaminated blood-thinner heparin, and the sometimes fatal cardiac effects of the diabetes drug Avandia (rosiglitazone), it is clear to the FDA that it needs to have better oversight when it comes to medication safety.

Three years after the FDA’s authority was broadened to allow it to require pharmaceutical manufacturers to conduct additional clinical studies or change medication labels (among other new powers), the FDA still has concerns about medication risks. Drug safety has always been an issue for the FDA, but given the recent high-profile troubles with the recalled painkiller Vioxx (rofecoxib), the contaminated blood-thinner heparin, and the sometimes fatal cardiac effects of the diabetes drug Avandia (rosiglitazone), it is clear to the FDA that it needs to have better oversight when it comes to medication safety.

At the time of this writing, FDA Commissioner Margaret Hamburg declined to give details of specific actions the agency would take, but she did tell lawmakers at a US House of Representatives budget panel that she was “moving forward with some strategies to enhance how we address drug safety.” She also said that details of her plans would be revealed “very soon.”1

References:

Reference
1. Reuters. Despite law, drug safety still a concern at FDA. March 10, 2010. http://www.reuters.com/article/idUSTRE62953P20100310. Accessed March 15, 2010.