The Rheumatologist
COVID-19 NewsACR Convergence
  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed
  • Home
  • Conditions
    • Rheumatoid Arthritis
    • SLE (Lupus)
    • Crystal Arthritis
      • Gout Resource Center
    • Spondyloarthritis
    • Osteoarthritis
    • Soft Tissue Pain
    • Scleroderma
    • Vasculitis
    • Systemic Inflammatory Syndromes
    • Guidelines
  • Resource Centers
    • Axial Spondyloarthritis Resource Center
    • Gout Resource Center
    • Psoriatic Arthritis Resource Center
    • Rheumatoid Arthritis Resource Center
    • Systemic Lupus Erythematosus Resource Center
  • Drug Updates
    • Biologics & Biosimilars
    • DMARDs & Immunosuppressives
    • Topical Drugs
    • Analgesics
    • Safety
    • Pharma Co. News
  • Professional Topics
    • Ethics
    • Legal
    • Legislation & Advocacy
    • Career Development
      • Certification
      • Education & Training
    • Awards
    • Profiles
    • President’s Perspective
    • Rheuminations
    • Interprofessional Perspective
  • Practice Management
    • Billing/Coding
    • Quality Assurance/Improvement
    • Workforce
    • Facility
    • Patient Perspective
    • Electronic Health Records
    • Apps
    • Information Technology
    • From the College
    • Multimedia
      • Audio
      • Video
  • Resources
    • Issue Archives
    • ACR Convergence
      • Gout Resource Center
      • Axial Spondyloarthritis Resource Center
      • Psoriatic Arthritis
      • Abstracts
      • Meeting Reports
      • ACR Convergence Home
    • American College of Rheumatology
    • ACR ExamRheum
    • Research Reviews
    • ACR Journals
      • Arthritis & Rheumatology
      • Arthritis Care & Research
      • ACR Open Rheumatology
    • Rheumatology Image Library
    • Treatment Guidelines
    • Rheumatology Research Foundation
    • Events
  • About Us
    • Mission/Vision
    • Meet the Authors
    • Meet the Editors
    • Contribute to The Rheumatologist
    • Subscription
    • Contact
  • Advertise
  • Search
You are here: Home / Articles / U.S. FDA Moves to Prevent Pharma from “Gaming” Generic Drug System

U.S. FDA Moves to Prevent Pharma from “Gaming” Generic Drug System

June 21, 2017 • By Toni Clarke

  • Tweet
  • Email
Print-Friendly Version / Save PDF

WASHINGTON (Reuters)—The U.S. Food and Drug Administration moved on Wednesday to prevent pharmaceutical companies from “gaming” the system to block or delay entry of generic rivals.

You Might Also Like
  • U.S. House Panel Spotlights Use of FDA Rules to Slow Generic Drugs
  • U.S. Could File Charges in Generic Drug Probe by Year-End
  • Sun Pharma Gets U.S. Subpoena over Generic Drugs Pricing
Also By This Author
  • U.S. Senate Moves Closer to Confirming Califf to Lead FDA

FDA Commissioner Scott Gottlieb said in a blog post that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA rules to place obstacles in the way of generic competition.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

“We know that sometimes our regulatory rules might be ‘gamed’ in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition,” he said in the blog post. “We are actively looking at ways our rules are being used and, in some cases, misused.”

The move comes as President Donald Trump and lawmakers in Congress search for ways to lower the cost of prescription drugs. Trump is preparing to put out an executive order on drug pricing, according to media reports, and last week U.S. Senator Ron Wyden introduced a bill to require companies to explain the reasons for significant price increases.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

“Americans are sick and tired of seeing the cost of their prescription drugs race past their paychecks,” said Wyden, an Oregon Democrat.

The FDA does not include price considerations when deciding whether to approve a new drug, but Gottlieb said the agency can facilitate increased competition by approving lower-cost generics. That means removing some of the obstacles placed by branded companies in the way of generic manufacturers.

These obstacles can include limiting the availability of branded products for testing by generic companies, or prolonging negotiations with generic companies over the implementation of shared risk-management programs.

ad goes here:advert-3
ADVERTISEMENT
SCROLL TO CONTINUE

Gottlieb said the agency plans to examine policy and program changes, including using its own authorities more forcefully and potentially collaborating more closely with other health agencies.

Representatives from the pharmaceutical industry’s main lobbying group, the Pharmaceutical Research and Manufacturers of America, were not immediately available for comment.

Filed Under: Drug Updates, Pharma Co. News, Practice Management, Professional Topics Tagged With: generic competition, pharmaceutical companies, U.S. Food and Drug Administration

You Might Also Like:
  • U.S. House Panel Spotlights Use of FDA Rules to Slow Generic Drugs
  • U.S. Could File Charges in Generic Drug Probe by Year-End
  • Sun Pharma Gets U.S. Subpoena over Generic Drugs Pricing
  • FDA’s Gottlieb Eyes PBM Consolidation Impact on Generic Entry: CNBC

Rheumatology Research Foundation

The Foundation is the largest private funding source for rheumatology research and training in the U.S.

Learn more »

Meeting Abstracts

Browse and search abstracts from the ACR Convergence and ACR/ARP Annual Meetings going back to 2012.

Visit the Abstracts site »

American College of Rheumatology

Visit the official website for the American College of Rheumatology.

Visit the ACR »

The Rheumatologist newsmagazine reports on issues and trends in the management and treatment of rheumatic diseases. The Rheumatologist reaches 11,500 rheumatologists, internists, orthopedic surgeons, nurse practitioners, physician assistants, nurses, and other healthcare professionals who practice, research, or teach in the field of rheumatology.

About Us / Contact Us / Advertise / Privacy Policy / Terms of Use / Cookie Preferences

  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed

Copyright © 2006–2023 American College of Rheumatology. All rights reserved.

ISSN 1931-3268 (print)
ISSN 1931-3209 (online)