FTC Seeks Comments on Competition in Prescription Drug Markets

Ahead of a November workshop in which FDA Commissioner Scott Gottlieb will give a keynote address, the Federal Trade Commission (FTC) is seeking comments on a variety of questions related to competition issues in the US prescription drug market.

The free and public workshop on 8 November will explore considerations that may stop the entry of generic drugs even after relevant patents have expired on brand-name products, including factors related to prices and other issues. Among these other issues are tactics that can delay or halt competition, such through a lack of sample-sharing or participation in a shared safety protocol. 

In addition, FTC says the workshop will evaluate intermediaries in the pharmaceutical supply chain, focusing on pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs), to discuss how the contractual relationships between intermediaries, manufacturers and health plan sponsors impact prices.

Prior to the workshop, the FTC is seeking comments on the following questions:

• Do generic drug manufacturers have sufficient incentives to enter markets where the brand drug is off-patent? Do policymakers or market participants have a role in providing incentives to encourage entry decisions that better align with the public interest?
• Are reports on strategies to reduce generic drug competition when the branded drug is off-patent accurate? If so, what steps are taken to reduce competition? If not, are there other reasons why generic entry is not seen as robust? What can be done?
• What role do intermediaries, such as PBMs and GPOs, play in prescription drug pricing, consumer access and quality? What are the benefits and costs of intermediaries in the supply chain? Has consolidation affected price, access or quality?
• How do companies assess the benefits, costs and risks of contracting with intermediaries? How well do consumers understand intermediaries’ roles? Is more information necessary?
• How should stakeholders evaluate proposals to reduce drug prices and increase consumer access in prescription drug markets? What role can the FTC play in addressing these issues?