BOSTON (SHNS) – The federal agency charged with promoting competition and upholding antitrust laws has launched an inquiry into the business practices of six powerful pharmacy benefit managers.

The Federal Trade Commission voted 5-0 Monday to order the companies to provide documents and data as part of a look at the impacts of the “prescription drug middleman industry” on access and affordability of prescription drugs, as well as effects on competing pharmacies, health care payers, doctors, and patients.

The commission described PBMs – CVS Caremark, Express Scripts, OptumRx, Humana, Prime Therapeutics, and MedImpact Healthcare Systems – as “at the center of the U.S. pharmaceutical system.” The companies are hired to negotiate rebates and fees with drug manufacturers, create drug formularies and policies, and reimburse pharmacies for patients’ prescriptions, the FTC said, and largest PBMs are integrated with the largest health insurance companies and wholly-owned mail order and specialty pharmacies.

“Pharmacy benefit managers often have enormous influence on which drugs are prescribed to patients, which pharmacies patients can use, and how much patients ultimately pay at the pharmacy counter,” the FTC said. “Many of these functions depend on highly complicated, opaque contractual relationships that are difficult or impossible to understand for patients and independent businesses across the prescription drug system.”

The FTC said it hopes through its inquiry to shed light on “several practices that have drawn scrutiny in recent years,” including fees and clawbacks charged to unaffiliated pharmacies, methods to steer patients towards PBM-owned pharmacies, “complicated and opaque” methods to determine pharmacy reimbursement, the use of specialty drug lists and policies, and the impacts of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients.

“This is a critical step to increase scrutiny of powerful companies within the U.S. pharmaceutical system,” FTC Chair Lina Khan said in a statement, adding, “Given that PBMs’ practices can have life-and-death consequences for Americans, the FTC has a moral imperative to act with urgency on this issue.”

Commissioner Rebecca Kelly Slaughter went further, saying the commission’s unanimous vote “underscores the consensus echoed by patients, independent pharmacies, and myriad other stakeholders: something is rotten in the state of the U.S. pharmaceutical market, and it warrants serious investigation.”