House Turns its Attention to Drug Safety

Dec 22, 2010   

Now that food safety reform is underway, Congress has turned its focus to drug safety. House Democrats have recently introduced a Bill (H.R. 6543) that is expected to increase the FDAs enforcement power over both foreign and domestic drugs.

The Drug Safety Enhancement Act, like the recently-passed Food Safety Modernization Act, contains various provisions aimed at minimizing risks to consumers and increasing FDA oversight. Some of these provisions include: creating an updated registration process for both domestic and foreign facilities, prohibiting the entry of drugs coming from facilities that are noncompliant with FDA inspections or that otherwise lack safety documentation, and heightened enforcement powers, such as mandatory recall authority.

The sponsors of the Bill, Representatives John Dingell (Mich.), Henry Waxman (Cali.), Frank Pallone (N.J.) and Bart Stupak (Mich.), are all major players in FDA legislation. Together, they have been able to secure the passage of many proposals that they have initiated, and in doing so, have been able to expand the FDAs powers. Although the drug safety proposal comes at a time when House Democrats will soon lose majority status in the House, it is likely that the influential proponents of the Bill introduced the Act as a signal of things to come in 2011.

For more information regarding FDA regulatory compliance, please contact us at contact@fidjlaw.com.