On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop 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. Part of the goal of the workshop is to identify obstacles to competition and discuss policy steps that can increase the availability of generic drugs to consumers.
The Hatch-Waxman Act (the Act), which Congress passed over 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 helped reduce patent-related barriers to generic drug entry, which, in turn, has increased 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.
The FTC’s Acting Chairman has recognized the important role of competition in containing prescription drug costs, observing that “[d]uring the last decade, generic drugs have saved Americans more than $1.67 trillion.” Acting Chairman Ohlhausen has also commented that “[i]n 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.”
Likewise, the FDA Commissioner Gottlieb has identified increasing competition in the market for prescription drugs and facilitating entry of lower-cost alternatives (like generics and biosimilars) as one his highest priorities. This summer we blogged on some of his efforts in that area (click here and here), and in July 2017 the Agency held a public meeting called “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” Stakeholder comments on the issues raised during the FDA public meeting are still being accepted; the submission deadline is November 17th.
Other recent actions by FDA related to reducing the barriers to generic competition include its issuance of a new draft guidance intended to assist the development of certain complex generic products, as well as the issuance of multiple new and final guidance documents explaining various procedures to generic drug applicants in order to increase the quality of those applicants. Internal guidelines for Agency reviewers have also been updated to provide for better communications with and more transparency for the industry. And FDA has hired hundreds of new scientific reviewers under the new Generic Drug User Fee Act, which explains in part why the number of generic applications approved in FY17 is the largest number approved in a single year since the enactment of Hatch-Waxman (763 full approvals).
The FTC workshop (which is free and open to the public) will be at the Constitution Center Auditorium, 400 7th St., SW, Washington, DC. The event begins at 8:30 a.m. on November 8, 2017 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.
The first session 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 (with a focus on pharmacy benefit managers and group purchasing organizations). 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 ways to encourage entry and eliminate competitive impediments in prescription drug markets.