• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » New bipartisan legislation to address prescription drug shortages

New bipartisan legislation to address prescription drug shortages

February 6, 2012
CenterWatch Staff

U.S. Representatives John Carney (D-Del.) and Larry Bucshon (R-Ind.) introduced the Drug Shortage Prevention Act Jan. 31, which addresses the scarcity of certain pharmaceutical drugs in the marketplace.

Last year, there were more than 230 different drug shortages, overwhelmingly affecting cancer drugs, anesthesia drugs and nutrition medicines. These drugs are delivered intravenously, as opposed to in a pill form, and the manufacturing process is complex, time-consuming and highly precise. Many of these drugs have only one or two manufacturers in the market, so when a manufacturing problem occurs it can quickly cause a shortage.

The proposed act mandates expedited review of drugs vulnerable to shortages, to prevent them, and it requires the FDA to use a more refined regulatory process that addresses manufacturing problems without instigating drug shortages. The bill also streamlines communications between the FDA, manufacturers, distributors, providers and patients to ensure that all parties have the information they need to act proactively—instead of reactively—to prevent shortages from occurring.

“Since 2005, the number of drug shortages in the United States has quadrupled, and cancer patients have been disproportionately impacted by this troubling trend,” said Carney. “The Drug Shortage Prevention Act brings more efficiency to the manufacturing and distribution processes and requires the FDA to take action to prevent drug shortage problems before they begin impacting patients.”

“As a physician, drug shortages for patients who need specialized care is a critical issue that deals directly with the well-being of our citizens,” said Bucshon. “It is vital that we are proactive when it comes to preventing shortages and ensuring access to treatments that save lives and improve health.  I am proud to work across the aisle with my colleague from Delaware on an issue of national importance that will truly improve the quality of life for the American people.”

The Drug Shortage Prevention Act is supported by the American Society of Clinical Oncology, the American Society for Parenteral and Enteral Nutrition, AstraZeneca and the Hematology/Oncology Pharmacy Association.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

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

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing