The Federal Trade Commission will hold a workshop on November 8, 2017 entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” Acting FTC Chairman Maureen K. Ohlhausen and U.S. Food and Drug Commissioner Dr. Scott Gottlieb will give the keynote addresses.
The Hatch-Waxman Act, passed by Congress more than 30 years ago, provides a regulatory and judicial framework to expedite generic entry into U.S. prescription drug markets. For many drugs, the Act has succeeded in lowering patent-related barriers to generic drug entry, thereby spurring additional competition that has led to lower drug prices. In 2010, Congress created a similar framework for biosimilar drug development under the Biologics Price Competition and Innovation Act.
“Competition is key to containing prescription drug costs. During the last decade, generic drugs have saved Americans more than $1.67 trillion,” said Acting Chairman Ohlhausen. “In light of concerns about rising drug prices, it's critical we identify barriers that may prevent drugs from entering the market, even after applicable patent protections have expired.”
“One of my highest priorities as FDA Commissioner is to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives, like generics,” said Dr. Gottlieb. “At the FDA we’re working hard to reduce barriers to generic competition. We’re pleased to be part of the FTC’s important workshop as part of our efforts to identify obstacles to competition and discuss policy steps that can increase the availability of generic drugs for consumers. I am committed to doing all we can under the FDA’s authority to help reduce the burden on consumers, so that no patient is ever priced out of access to a medicine they need to cure a disease or maintain their health.”
The first session of the workshop will explore generic drug markets, including considerations that may preclude entry after relevant patents have expired. Panelists will discuss price and non-price factors that may influence entry in these markets. The second session will evaluate intermediaries in the pharmaceutical supply chain, focusing on pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs). Panelists will discuss how the contractual relationships between intermediaries, manufacturers and health plan sponsors ultimately affect the prices consumers pay for prescription drugs. Throughout the day, speakers will discuss means to encourage entry and eliminate competitive impediments in prescription drug markets.
The workshop, which is free and open to the public, will be at the FTC’s Constitution Center Auditorium, 400 7th St., SW, Washington, DC. The event begins at 8:30 a.m. and will be webcast live on the FTC’s website. Registration information, an agenda, directions to the FTC Conference Center, and a list of speakers will be available in the near future on the event web page. Advance registration is not required, but is strongly encouraged.
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Office of Public Affairs
Office of Acting Chairman Maureen K. Ohlhausen
Deputy Director, Office of Policy Planning