Please login to the form below

Not currently logged in
Email:
Password:

Bill would increase FDA drug-safety powers

Members of the US House of Representatives have moved toward increasing the US Food and Drug Administration's authority regarding drug safety

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.

24th September 2010

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Synergy Vision

Synergy Vision believe in delivering medical communications that make a difference to healthcare professionals and patients. Our synergy of pharma...

Latest intelligence

AstraZeneca’s oncology renaissance
Susan Galbraith played a key role in restoring AstraZeneca’s place in cancer drug development – she talks about the future of oncology and why there’s more to be done to...
Navigating the antibiotic resistance crisis
Blue Latitude Health speaks to Tara DeBoer, PhD, Postdoctoral Researcher and CEO of BioAmp Diagnostics to explore the antimicrobial resistance crisis, and learn how a simple tool could support physicians...
Combined immunotherapies – potential and pitfalls
‘Combining therapeutic compounds is the first logical step towards better results, namely higher rates of patients responding to treatment, with deeper and more sustained responses’...

Infographics