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:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.

Medical marketing needs mainstream Mad Men

Medical marketing needs mainstream Mad Men

Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike

Are discounts cutting out co-pays?

GSK's decision to cut Advair's price spurred some PBMs to put it back on formulary. Will drugmaker discounts diminish the need for loyalty programs? How can these programs stay relevant beyond giving co-pay assistance?