Event Description
As part of implementing President Trump’s Executive Order No. 14273, Lowering Drug Prices by Once Again Putting Americans First, the Federal Trade Commission and the Department of Justice, along with the Department of Health and Human Services and the Department of Commerce, will jointly host three listening sessions to discuss ways to make prescription drugs more affordable for Americans by promoting competition. The three listening sessions will occur under the direction of FTC Chairman Andrew Ferguson Assistant Attorney General Gail Slater of the DOJ Antitrust Division.
The listening sessions will focus on improving the affordability of pharmaceuticals by increasing generic and biosimilar availability and promoting competition through drug formularies and benefits. The sessions, which will feature remarks by practitioners and scholars, will cover anticompetitive practices as well as suggestions for eliminating regulatory barriers and rent seeking. The listening sessions will inform the joint report on combatting anticompetitive practices in pharmaceutical markets, as mandated by President Trump’s Executive Order.
Attendance in-person is by invitation. Members of the public may submit questions using this link and may access the livestream from the pages linked below. After each session, videos and transcripts will be available on the session’s page.
The dates for the sessions are as follows:
- Monday, June 30 at 2 pm ET – Anticompetitive Conduct by Pharmaceutical Companies Impeding Generic or Biosimilar Competition
Panel 1: Anticompetitive Conduct to Delay, and Forestall Competition From Lower-Priced Alternatives
This panel will focus on strategies employed by incumbent manufacturers to delay or exclude generic or biosimilar competition. It will provide an overview of recent trends in pharmaceutical patent settlements as well as other strategies employed by these manufacturers to preserve their market share. Specific potential anticompetitive practices to be discussed include:
- Current trends around potential pay-for-delay agreements
- Exclusive agreements for API supply and restricted distribution
Panel 2: Anticompetitive Conduct to Impede and Reduce Competition from Lower-Priced Alternatives
This panel will focus on strategies employed by incumbent manufacturers to preserve their market share even after generic or biosimilar entry. Specific potential anticompetitive practices to be discussed include:
- Current trends around potential pay-for-delay agreements
- Exclusive agreements for API supply and restricted distribution
- Thursday, July 24 at 2 pm ET – Formulary and Benefit Practices and Regulatory Abuse Impacting Drug Competition
Panel 1: Benefit and Formulary Practices and Regulations that Harm Drug Competition
This panel will focus on the business relationship between drug manufacturers and PBMs that may impact drug competition, resulting in higher drug costs for health plan sponsors and patients. This panel will also focus on how applicable regulations distort competitive incentives or encourage firms to focus on rent seeking, rather than price and quality. The panel will address a variety of topics, including:
- Impact of vertical integration of the health insurer, PBM, and specialty pharmacy on incentives to reduce drug costs
- Formulary design and rebating practices
- Private label biosimilars
- Medicare policies and regulations
- Interchangeability of biosimilars
Panel 2: Improper Orange Book Listings and Other Regulatory Abuse by Pharmaceutical Companies to Impede Competition
This panel will discuss the anticompetitive concerns from improper Orange Book listings and sham litigation. The panel will describe the interplay between the various agencies tasked with overseeing this conduct (e.g., FDA, PTO, FTC, and DOJ) and suggest how these agencies can better collaborate to combat potential anticompetitive conduct.
- Improper Orange Book listings or sham petitioning to FDA
- Misuse of the REMS process
- Disparaging the safety and efficacy of generics, biosimilars and interchangeability to hinder the uptake of lower-priced alternatives.
- Monday, August 4 at 2 pm ET – Turning Insights into Action to Reduce Drug Prices
This session will highlight the most impactful discussion from the previous two sessions. It will also include discussion of other potential strategies to reduce drug pricing in the United States.