The Federal Trade Commission responded to the U.S. Department of Health and Human Services’ request for comment to its publication, Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. The publication seeks to “increase competition and end the gaming of regulatory processes that may keep drug prices artificially inflated or hinder generic, branded, or biosimilar competition.”
“The Federal Trade Commission is committed to maintaining competition in the pharmaceutical industry,” FTC Chairman Joe Simons said. “The pharmaceutical industry provides American consumers with access to life-saving medicines and significantly affects our economy. Regulatory barriers and abuse of government processes that delay and constrain competition can lead to higher prices and reduce access to those medicines – all to the detriment of consumers. The FTC firmly believes that a vibrant, competitive marketplace offers the greatest benefits to consumers. The Commission’s comments are directed toward that goal.”
The FTC comment focuses on two topics in the Blueprint that affect a significant portion of U.S. health care expenditures: misuse of Risk Evaluation and Mitigation Strategies (REMS) programs and biologic competition.
REMS programs can protect the public from pharmaceutical abuse, but they can also be misused to disrupt competition and innovation. The Commission’s comment suggests that branded manufacturers may abuse REMS programs by refusing to make product samples available to generic manufacturers and by denying access to shared REMS systems, both of which are necessary for generic firms to obtain approval for generic drugs and biosimilars from the U.S. Food & Drug Administration. The FTC supports regulatory and legislative actions aimed at correcting the misuse of REMS programs.
Biologics treat serious medical conditions and comprise the fastest growing and one of the most expensive segments of prescription medicine. The Commission’s comment suggests that certain FDA regulations create unnecessary barriers to biosimilar and interchangeable competition. The FTC recommends that the FDA reconsider its naming guidance for biologics and expedite the approval process for interchangeable biosimilars, which likely would increase market acceptance and competition for lower cost biosimilar products.
The Commission vote approving the statement was 5-0. (FTC File No. V180008; the staff contact is Elizabeth Jex, Office of Policy Planning, 202-326-3273)