May 7, 2019
(Washington, D.C.) —Pharmaceutical Care Management Association (PCMA) President and CEO JC Scott issued the following statement on the Senate Judiciary Committee hearing, “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition:”
“We applaud the Senate Judiciary Committee for examining the impact of intellectual property on competition in the prescription drug marketplace.
Drug manufacturers’ abuse of the patent system, including use of pay-for-delay tactics and litigation on biosimilars, can significantly delay generic and biosimilar launches in the U.S. market. These tactics limit the ability of pharmacy benefit managers, PBMs, to reduce prescription drug costs through leveraging competition among drug manufacturers and their products.
While to date the Food and Drug Administration (FDA) has approved 17 biosimilars, only seven are currently on the market in the U.S., compared to 51 in Europe. Ongoing litigation for several high-priced treatments has kept competition on the sideline. For example, since 2016, the FDA has approved four biosimilar products for Humira, yet none will be available in the market until 2023 due to manufacturer lawsuit settlements.
In addition, patent settlements, or pay-for-delay agreements, allow drug patent holders to pay off potential competitors who would otherwise produce a competing generic or biosimilar drug. These anticompetitive agreements should be eliminated.
We look forward to working with the Committee and other members of Congress to address these patent abuses that block competition from entering the market.”
Click here to learn more: PCMA Infographic on Biosimilar Litigation and Competition