Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Drug import bill sidetracked as food safety measure advances ahead of health reform freight train

This article was originally published in The Gold Sheet

Executive Summary

The House Energy and Commerce Committee has sidetracked drug and device import legislation to concentrate on food safety in the short window before healthcare reform dominates its agenda. Observers are left wondering when the committee will get around to advancing the non-food aspects of the Food and Drug Globalization Act it reintroduced earlier this year. Some of those provisions, like registration and fees for post-approval inspections of overseas drug manufacturing facilities, were a high priority in the months after last year's heparin fiasco. The committee June 17 marked up its Food Safety Enhancement Act, H.R. 2749, which incorporates food-related provisions from the tabled FDAGA, and rushed it on for consideration by the full House. "It seems like drug safety and medical devices will be worked in the near future," a Dingell spokesman assured "The Gold Sheet." However, healthcare reform legislation looms. "Clearly, it is a crowded calendar," the spokesman noted, "but this is something all the members want dealt with as soon as possible.

You may also be interested in...



Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Liquid Biopsy Company Delfi Diagnostics Raised $100M For New Class of Early Cancer Detection Test

Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials. 

Biotin And ‘Healthy Hair’: Federal Pre-emption Clips False Advertising Complaint In California

US Ninth Circuit affirms a district court’s summary judgment in favor of Target and manufacturer of Up & Up brand biotin supplement it sells. Indian manufacturer targeted in putative class-action in New York prompted FDA’s 2016 creation of import alert category for Ayurvedic supplements.

UsernamePublicRestriction

Register

LL1134025

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel