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 » ORPHAN DRUG APPROVALS INCREASING

ORPHAN DRUG APPROVALS INCREASING

May 1, 2006

More than 160 drugs to treat rare diseases were approved by the FDA from 1995-2005, according to a report issued recently by PhRMA, the National Organization for Rare Disorders and the Genetic Alliance.

In comparison, there were 108 approvals from 19841994 and fewer than 10 in the 1970s, the report said.

Orphan drugs treat diseases that affect fewer than 200,000 people in the United States. According to the NIH's Office of Rare Diseases, there are 6,000 to 7,000 rare diseases that collectively affect approximately 25 million -- or one in 10 -- Americans.

One major driver of the increase in approvals was the passage of the Orphan Drug Act in 1983, which helped boost investment in research and development, the report said. The act provided tax relief and some marketing exclusivity for companies that developed an orphan drug. Scientific advancements also helped by improving understanding of molecular and genetic causes of rare diseases, according to the report.

KEYWORDS FDAnews Drug Daily Bulletin

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

  • Hyris T-Cell Test Gains CE-IVD Mark

  • FDA Expands Approval of Bayer’s Nubeqa for Prostate Cancer

  • MicroPort Navibot Receives 510(k) Clearance for Its SkyWalker System

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