Bill would increase FDA drug-safety powers

Key members of the US House of Representatives have taken a step toward increasing the US Food and Drug Administration's (FDA) authority regarding drug safety, with a particular focus on drugs manufactured overseas.

The lawmakers – John D Dingell, chairman emeritus of the Energy and Commerce Committee; Henry Waxman, chairman of the Energy and Commerce Committee; Frank Pallone, chairman of the Subcommittee on Health; and Bart Stupak, chairman of the Subcommittee on Oversight and Investigations – have released a discussion draft of new legislation that is intended "to equip the Food and Drug Administration with the authorities and funding it needs to regulate what is now a global marketplace for drugs."

The proposed legislation requires parity between foreign and domestic drug facility inspections, increases the number of preapproval drug inspections, requires safety documentation for drugs imported into the US, and requires manufacturers to ensure the safety of their supply chain. It also gives the FDA the authority to require recalls of drugs it deems unsafe, rather than just to request that manufacturers recall the drugs.

The draft is an extension of H.R. 759, also known as the Food and Drug Globalization Act, which was introduced by Dingell, Pallone and Stupak in 2009. 

Other legislation with similar goals has been introduced in both the Senate and the House this year. In July, Ed Towns, chair of the House Committee on Government Oversight and Reform, introduced the FDA Mandatory Recall Bill to increase the agency's drug recall powers. The following month, Senator Michael Bennet introduced the Drug Safety and Accountability Act, which would increase the FDA's authority to regulate drugs manufactured overseas as well as its regulatory powers over nonprescription drugs.