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Capitol Checkup: PBMs commit to testify; US FDA reorganizes; House probes Purdue

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Capitol Checkup: PBMs commit to testify; US FDA reorganizes; House probes Purdue

All five of the pharmacy benefit manager companies summoned to appear before the Senate Finance Committee to explain the industry's role in the high costs of U.S. prescription medicines have agreed to send executives to testify in April.

The hearing was initially set to take place on April 3, but NATO Secretary General Jens Stoltenberg is now scheduled to address Congress that day at a joint session on Capitol Hill. So the committee has moved the hearing with the pharmacy benefit managers, or PBMs often called middlemen to April 9.

In February, the Senate Finance Committee heard from executives from seven biopharmaceutical companies.

The panel's Republican and Democratic leaders — Sens. Chuck Grassley, R-Iowa, the chairman, and Ron Wyden, D-Ore., the ranking member — said it was now "only fair that the committee has the opportunity to ask questions of other players in the healthcare supply chain."

Those expected to appear before the committee are Derica Rice, executive vice president at CVS Health Corp. and president of its CVS Caremark unit; John Prince, CEO of UnitedHealth Group Inc.'s OptumRx; Mike Kolar, interim president and CEO at Prime Therapeutics LLC; William Fleming, healthcare services segment president at Humana Inc.; and Steven Miller, chief clinical officer at Cigna Corp., which recently acquired Express Scripts.

PBMs have been a particular target of the Trump administration, which has proposed ending the safe harbor protections that allow those companies to secure lucrative rebates from drugmakers under secret deals.

White House seeks to finalize TV ad rule

Meanwhile, the White House Office of Management and Budget, or OMB, is reviewing a final rule by the U.S. Centers for Medicare and Medicaid Services that would require drugmakers to include the list prices of their medicines in television advertisements aimed at consumers.

The administration has insisted that "not only does transparency promote a more competitive environment, but data indicate that it will likely motivate manufacturers to be less willing to raise prices, which have dramatically increased over the past decade."

CMS initially unveiled its proposal in October 2018, though the administration had long been promoting the idea, including in its strategic plan to lower drug prices. The OMB took about two months to review the proposed rule before taking public comment on the idea.

New coalition targets high drug prices

A group of consumer advocates, healthcare providers and labor unions last week formed a new coalition to develop a package of policy recommendations aimed at lowering drug prices.

Drug prices are "so astronomically high they create a financial crisis for families," said Frederick Isasi, executive director of the advocacy group Families USA, which has partnered with the other organizations to launch the Coalition for Fair Drug Prices.

The group has called for true transparency in the drug development and pricing processes.

Departing FDA chief overhauls office

One of U.S. Food and Drug Administration Commissioner Scott Gottlieb's last duties at the agency will be implementing a restructuring plan he outlined for his office — a reorganization that takes effect on March 31, just days before he departs on April 5.

In a March 21 memo to employees, Gottlieb said the reorganization would elevate the role of the FDA's drug and device and other centers in support of the agency's science-driven culture and would consolidate the work in the operations office to more effectively support regulators' mission and strengthen staffing and recruiting functions.

In a separate memo, Janet Woodcock, director of the Center for Drug Evaluation and Research, noted that as part of the reorganization, the FDA was creating a new Office of Therapeutic Biologics and Biosimilars within the Office of New Drugs.

"The increasing complexities and visibility of this program require a dedicated office," Woodcock said.

The FDA recently lost the head of its biosimilars program, Leah Christl, to Amgen Inc.

The FDA also has created a third oncology division and a second hematology division within its cancer drugs office.

Woodcock emphasized that the structural changes being put into effect on March 31 are separate from a broader overhaul planned for the Office of New Drugs that Gottlieb outlined in June 2018.

The drug center chief also revealed last week that the FDA was losing the head of its compounding program, Julie Dohm, on March 29.

House Oversight chief probes OxyContin

Rep. Elijah Cummings, D-Md., the chairman of the House Oversight and Reform Committee, demanded certain documents from Purdue Pharma LP about the Sackler family's involvement in promoting the company's powerful opioid medicine OxyContin and the FDA's expansion of the drug's labeling in 2001.

The Sacklers bought Purdue in 1952 and continue to own a controlling share of the company.

Purdue and the Sackler family have been the subject of a number of lawsuits over OxyContin and the company's role in the opioid crisis. Earlier this month, Purdue said it was considering filing for bankruptcy.