Tomorrow at 2 p.m., EST, the President is scheduled to deliver a long-awaited drug pricing strategy speech to put “America’s patients first.” While details of the speech have been closely held, it is anticipated that it will discuss a “comprehensive strategy” for combating the rising cost of prescription drugs and build on two previous actions which focused on drug pricing. First, in February of this year, White House Council of Economic Advisers released a white paper, in which it recommended easing regulations and expediting Food and Drug Administration (FDA) approvals of generics, as well as pushing competition among pharmacy benefit managers and reining in reimbursement under the 340B drug discount program. Second, the President’s Fiscal Year 2019 budget, previously discussed on this blog, called for caps on out-of-pocket spending for enrollees in Medicare’s prescription drug program and a five state pilot to test drug coverage and financing in their Medicaid programs. However, some Administration officials have suggested tomorrow’s proposals could go beyond these ideas and that “every ox will be gored.”

In the run-up to tomorrow’s speech the Affordable Prescription Drug Task Force, led by House Democratic Representatives Lloyd Dogget (D-TX), Peter Welch (D-VT) and Elijah Cummings (D-MD) released their priorities. They suggest that any “meaningful” proposal should “at least include”:

  1. Negotiate prescription drug prices under Medicare to harness the purchasing power of the federal government, as the President has previously proposed;
  2. Shed light on the pharmaceutical corporation’s drug pricing system through genuine transparency to reveal the true cost of drug production, as the President has previously proposed;
  3. End patent system abuse by eliminating tactics that thwart competition like pay-for-delay deals, patent evergreening, and Risk Evaluation and Mitigation Strategies (REMS) abuse;
  4. Allow safe importation of prescription drugs from other countries, as the President has previously proposed; and
  5. Ensure access to affordable drugs by crafting fair trade agreements.

While there have been conflicting messages on the scope of the proposal, one metric for determining the near-term impact will be whether it calls for new legislation or it relies on existing or expanded regulatory authorities.

Stay tuned! We will be montioring the speech and posting an update following its conlusion