Huge FDA changes in Globalization Act of '08

Share this article:
Three key leaders of the House Energy and Commerce Committee are circulating a discussion draft of their proposed Food and Drug Administration Globalization Act of 2008 as a means to provide adequate funding and authority for the FDA to ensure safety of the nation's food, drug, medical device and cosmetic supply in an increasingly globalized marketplace.

A cover memo circulated by Reps. John Dingell (D-MI), Frank Pallone (D-NJ) and Bart Stupak (D-MI) in April said they intend to hold legislative hearings on the draft soon. 

The proposal would: create a registry of drug and device facilities serving US consumers; require payment of fees to fund drug and device inspections; require parity between foreign and domestic inspections so facilities are inspected every two years; restrict entry of imports lacking safety documentation; require verification of drug identity and purity; and other provisions.

“This discussion draft raises challenging policy questions, and we anticipate a vigorous debate on these issues,” the three lawmakers said.
Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Antidote: On Cystic Fibrosis treatments

Antidote: On Cystic Fibrosis treatments

Recent treatments in CF, including the inhaled antibiotic Tobramycin, have increased lifespan well into adulthood.

The $3 generic and the $1,000 pill: pharma outsiders just don't get it

The $3 generic and the $1,000 pill: pharma ...

What do you call the people who treat medical breakthroughs as if they were bank heists? Malicious? Uninformed? Not with it?

Leadership Exchange Uncut : The Agency-Client Relationship

Leadership Exchange Uncut : The Agency-Client Relationship

Click the above link to access MM&M's first Leadership Exchange Uncut e-book, "The Agency-Client Relationship"