Senate committee reschedules hearing on PBM reforms over procedural disagreements

The Senate Health, Education, Labor, and Pensions (HELP) Committee’s executive session on bipartisan generic drug and pharmacy benefit manager (PBM) reforms got off to a rocky start and an even rockier finish on Tuesday.

Committee leads Sens. Bernie Sanders and Bill Cassidy disagreed over committee procedures, and the session ended with an unexpected adjournment, despite Sanders’s desire to move forward. Instead, the committee rescheduled the markup of the bills to May 11, after it hears from executives of the three biggest PBM companies, Express Scripts, Optum Rx, and CVS Health on May 10.

“That’s not the way to run a committee,” Cassidy said. “It’s not the way that I build trust with my down dais that we’re actually working together as a team in order to get something accomplished. At some point, process matters. And I’m sorry to be a skunk in the room.”

In his opening remarks, Cassidy said that Sanders had accepted four last-minute amendments to the package of bills the pair had worked on together, and had not shared financial feedback from the Congressional Budget Office on three of the amendments.

One of those amendments came from New Hampshire Sen. Maggie Hassan. The amendment would allow the FDA to help generic drug makers get the right concentration of inactive ingredients and avoid “guessing games and unnecessary delays,” Hassan said.

The FDA requires certain generic injectable drugs to have the same concentration of active and inactive ingredients as their branded counterparts. The exact formula, however, is considered an industry trade secret, and during the review process, manufacturers must repeatedly test until they land on the correct formula, according to researchers at the University of Southern California.

“This is one of the amendments that unfortunately was taken off the table, in which we agreed on a bipartisan basis to not negotiate, for which I’ve not had the ability to vet with people in my broader conference. It’s unfortunate; I think I was probably one of those who voted for this last time,” Cassidy said.

Cassidy and Sanders introduced a package of bills last week that aims to increase transparency on PBM pricing, compel PBMs pass 100% of rebates they collect from drug makers back to health plans, and ban spread pricing, when PBMs charge health plans more for a drug than what they reimburse a pharmacy.

The bills would “[crack] down on the abuse of citizen petitions filed before FDA by brand-name companies that delay the introduction of affordable generic medicines,” prevent anti-competitive maneuvers, and encourage the development of drugs for rare diseases, Sanders said.

Both Republican and Democratic committee members agreed to postpone the markup of the bills until next week, adding that voting on the measures before hearing from PBM executives could lead to confusion.

“I’m worrying that the ordering of the hearings could compromise the ability to maximize the vote total coming out of this committee to get the momentum to put it on the floor,” Virginia Sen. Tim Kaine said.