Life Sciences, Regulatory Focus News Letter

New analysis highlights link between generic drug competition and lower drug prices, underscores importance of FDA efforts to spur generic drug development and market entry

Hi, Welcome to FWQRC Regulatory Focus News letter

  • The U.S. Food and Drug Administration posted a new analysis showing greater competition among generic drug makers is associated with lower generic drug prices.
  • It updates and expands on a previous analysis from 2005 and includes two different sources of wholesale drug prices – average manufacturer prices (AMP) reported to the Centers for Medicare and Medicaid Services and invoice-based wholesale prices reflecting pharmacy acquisitions from IQVIA’s National Sales Perspective database.
  • The analysis looked at all drug products that had initial generic entry between 2015 and 2017 and showed that as competition increases, generic drug prices decline.
  • For products with a single generic producer, the generic AMP is 39% lower than the brand drug price before generic competition, compared to a 31% reduction using invoice-based drug prices.
  • With two competitors, AMP data show that generic prices are 54% lower than the brand drug price before generic competition, compared to a 44% reduction using invoice-based drug prices.
  • With four competitors, AMP data show that the generic prices are 79% less than the brand drug price before generic entry, compared to a 73% reduction using invoice-based drug prices.
  • With six or more competitors, generic prices using both AMP and invoice-based drug prices show price reductions of more than 95% compared to brand prices before generic entry.
  • This analysis builds on earlier FDA work External Link Disclaimer comparing generic and brand drug prices and follows related studies.
  • Through ongoing efforts under the FDA’s Drug Competition Action Plan and the Generic Drug User Fee Amendments, the agency is further encouraging robust and timely market competition for generic drugs and helping bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program.
  • “This new analysis underscores the critical nature of the work the FDA is undertaking to encourage timely market competition from high-quality, safe and effective generic drugs, which can help provide patients with access to affordable therapies that treat a wide range of medical conditions.
  • “The FDA will continue to do all it can to support a robust, competitive generic drug market by helping facilitate a strong pipeline of applications, improving agency processes and providing industry with thoughtful, clear guidance and recommendations to support generic drug development and approval.”

Thank you for visiting FWQRC blogs

Contact FWQRC™ for GMP Training, Auditing by QP, eCTD, GAP Analysis, Risk Assessment, CAPA, CSV, Method development/Validation, ADE/PDE Values, Facility & Product Registrations

1 thought on “New analysis highlights link between generic drug competition and lower drug prices, underscores importance of FDA efforts to spur generic drug development and market entry”

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s