Following an announcement last week from Food and Drug Administration (FDA) Commissioner Scott Gottlieb about pending agency action on generic drug competition, a draft of an alleged White House executive order about drug pricing has leaked. However, a White House spokesperson has said that the leaked draft is a fake.

The leaked draft order aims to “increase access to affordable, safe, and effective medical products” while continuing to promote innovation. The order gives directives to various health-related agencies, including the Centers for Medicare and Medicaid Services (CMS), the FDA, and the Heath Resources and Services Administration (HRSA).

In the order, CMS is directed to explore new models and demonstrations to lower drug prices while also encouraging innovative approaches to benefit design. Like CMS, the FDA is also encouraged to advance innovation. In addition, the order call for a review of relevant regulations, such as those that “unnecessarily increase expenses” for patients and for biopharmaceutical manufacturers and researchers. Agency heads would be expected to submit findings and recommendations with their submissions for the President’s Fiscal Year 2019 Budget.

The order also gives directives to both the Internal Revenue Service (IRS) and the United States Trade Representative. For the IRS, the leaked order directs the Commissioner to update a section of the Internal Revenue Code about the preventive care safe harbor in high deductible health plans so that it can include benefits for preventing chronic disease progression or complication. This could give these plans more flexibility in covering preventive care. In addition, the Trade Representative would be instructed to review international polices related to drug purchasing and supply systems.

This leaked order comes following reports about steps that the White House was taking to address drug prices, including working on a drug pricing executive order. The timing for release of this or any drug pricing executive order is unclear, but administration officials have met to discuss such an order.