The Trump administration appears to be a step closer to issuing a proposed regulation and draft guidance on prescription drug importation.
Stakeholder meetings scheduled for early January were removed on Saturday from the Office of Management and Budget's website. A cancellation email obtained by Modern Healthcare stated that OMB "concluded review" on both the proposed rule and draft guidance.
Meetings were scheduled between OMB officials and two groups that oppose drug importation from Canada—the Partnership for Safe Medicines on Jan. 7 and Pharmaceutical Research and Manufacturers of America on Jan. 9.
"We hope that this is not politically motivated given the timing of such a move, particularly in light of the grave consequences of allowing drug importation. Both U.S. and Canadian stakeholders have provided clear and compelling arguments as to why this is a bad and unworkable idea. Even as the administration weighs its next move, the process itself should not be driven by anything but the health and safety of the American people," said Partnership for Safe Medicines Executive Director Shabbir Safdar.
The proposed rule and draft guidance align with the Trump administration's importation action plan, which laid out two potential pathways for bringing cheaper drugs into the U.S. One would allow states to import drugs from Canada, and another would allow drugmakers to import their own products and sell them under different drug codes.
HHS can approve importation programs if it certifies the move would not pose additional safety risks and would significantly reduce costs for American consumers.
President Donald Trump has repeatedly publicly asked HHS Secretary Alex Azar to authorize a Canadian prescription drug importation program in Florida. Sources suggested that Azar and the administration could use a political win to counter reported discord at HHS between the secretary and CMS Administrator Seema Verma.
HHS declined to state whether the proposed rule and draft guidance will be issued soon.
"We do not comment on the timing of regulations or guidance. The president and secretary are very much committed to implementing the Safe Importation Action Plan that was announced on July 31," an HHS spokesperson said.
The move comes just two days after Dr. Stephen Hahn was confirmed by the U.S. Senate as the new commissioner of the Food and Drug Administration.
