Draft drug price order focuses on regulations

WASHINGTON—The Trump administration might seek to roll back regulations in pursuit of faster drug approvals, promoting drug competition and new payment models for federal health insurance programs, according to a draft executive order obtained by CQ Roll Call.

Some of the items listed would benefit pharmaceutical companies, despite President Donald Trump’s pledge earlier this year to take steps to rein in the industry because he said it was “getting away with murder.” But the administration is also hinting that it could address some anti-competitive behavior in that sector. There are also a number of recommended proposals that could give incentives for the development of generic drugs.

The White House declined to comment on the draft document. Lobbyists who had been briefed on the draft confirmed its authenticity, and one drug industry lobbyist said he expected the executive order to be released next week.

The document instructs administrative agencies to review policies related to pharmaceutical research and development that could result in unnecessary price increases or expenses for manufacturers. The heads of relevant agencies are ordered to submit recommendations for policy changes when they submit their fiscal 2019 budget proposals.

The draft order would instruct the administration to seek more favorable trade agreements to help boost the prices of American prescription drugs sold overseas. The pharmaceutical industry argues that weak patent protections in foreign countries mean that Americans are stuck with higher prices to subsidize research and development.

The White House would have the Food and Drug Administration “address unintended consequences of existing rules that may reduce competition,” the document said.

FDA Commissioner Scott Gottlieb announced Wednesday that the FDA would hold a public meeting on ways to address anti-competitive behavior in the pharmaceutical industry. He specifically pointed to the abuse of drug safety protocols that some companies use to block generic competitors’ access to samples.