We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Senator Says Hamburg Not Aggressive Enough on Supply Chain

Senator Says Hamburg Not Aggressive Enough on Supply Chain

May 4, 2012

Sen. Sherrod Brown (D-Ohio) had harsh criticism for FDA Commissioner Margaret Hamburg recently, questioning the agency’s lack of enforcement actions against companies’ with holes in their supply chain knowledge.

The questions, which came during a Senate Appropriations subcommittee hearing on the FDA’s fiscal 2013 budget request, attacked the agency’s position on why it doesn’t hold companies more responsible for knowledge of their products’ supply chain.

“If a CEO is not certain where all the ingredients come from, and those ingredients coming from wherever end up killing a patient in Toledo, shouldn’t that CEO go to jail? Shouldn’t that company be fined huge amounts of money?” Brown asked. “I want these companies to be responsible for their ingredients.”

Pointing to the oft-cited example of the tainted Chinese heparin outbreak, Brown called on the agency to force drug manufacturers to be more responsible for their imported products.

Lawmakers are not alone in pressing for greater drugmaker accountability. The FDA has already handed out warning letters for insufficient supply chain knowledge and inadequate supplier agreements.

 To avoid such letters, it’s no longer enough to have purchasing agreements with shippers that make passing reference to quality contracts. You need ironclad supply chain quality agreements.
But what does a good quality agreement look like? How do you negotiate it with warehouses, wholesalers and shippers? And, then, how do you document compliance?

Here are the answers you need to “FDA-proof” your entire supply chain. An essential new management report from FDAnews, Warehousing and Shipping Supply Chain Quality Agreements: Key Considerations for Pharmaceutical Companies, explains the regulatory supply chain requirements that govern pharmaceutical warehousing and transport.

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

  • 11Oct

    1st Annual Quality Management vSummit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • AngioDynamics Gets Expanded Clearance for Auryon Atherectomy System

  • Aura Biosciences Receives Fast Track Designation for Bladder Cancer Candidate

  • FDA Issues Update on Becton Dickinson’s Recall

  • FDA Grants Accelerated Approval to Enhertu for HER2-Mutant NSCLC

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing