State officials are moving forward with prescription drug importation programs on President Donald Trump's repeated assurances that he wants to allow states to import drugs from Canada, though HHS has not approved any such program. Vermont on Tuesday will become the second state to submit an importation plan to HHS behind Florida.
Facilitating drug imports is one of Trump's favorite healthcare talking points and he reiterated his support for approving state plans on Friday. Republican Florida Gov. Ron DeSantis and Trump talked about drug imports on a phone call the day before.
HHS Secretary Alex Azar "and I will soon release a plan to let Florida and other States import prescription drugs that are MUCH CHEAPER than what we have now! Hard-working Americans don't deserve to pay such high prices for the drugs they need. We are fighting DAILY to make sure this HAPPENS…" Trump tweeted.
Colorado, Florida, Maine and Vermont have passed laws creating Canadian importation programs.
Vermont's plan differs in a few key ways from Florida's. Vermont's plan would apply to consumers in the commercial market instead of just those served by public payers. Plans would be required to pass any cost savings to consumers by lowering premiums, deductibles and co-pays for prescription drugs.
But Trump talks the most about approving Florida's plan, which the state submitted to HHS in August. Joe Grogan, chief of the White House Domestic Policy Council , on Nov. 8 singled out Florida and Colorado by name as partners on importation programs. HHS has legal authority to approve the programs if the department certifies the move would not pose additional safety risks and would significantly reduce costs for American consumers.
Florida is important for the presidential electoral map and Sen. Cory Gardner (R-Colo.) is one of the GOP's most vulnerable Senate incumbents up for re-election in 2020.
Despite not having approval from HHS, DeSantis on Nov. 18 asked state lawmakers to allocate $20 million to the state's nonexistent importation program. DeSantis told reporters that pharmaceutical lobbying was responsible for the delay.
"I wish I could say that this will happen tomorrow, but I just know how Washington works and I know specifically when you get into something that is dealing with probably the most powerful industry in Washington—certainly one of the top two or three—it just is never easy," DeSantis said, CBS Miami reported.
The Trump administration's drug importation plan has two pathways: 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.
Several groups with ties to the pharmaceutical industry have met or are scheduled to meet with officials from the White House Office of Management and Budget on pending Food and Drug Administration guidance that would implement the latter pathway.
Pharmaceutical Research and Manufacturers of America, the brand-drug industry lobby, met with White House budget officials Nov. 4.
"We requested the meeting to discuss issues pertaining to the guidance under review implementing pathway 2 of HHS's Safe Importation Action Plan. I'm not going to get into the specifics of the meeting or those in attendance," PhRMA spokesperson Nicole Longo said.
The Pharmaceutical Distribution Security Alliance, a group that represents industry stakeholders, including drugmakers, distributors and pharmacies, is set to meet with OMB about the guidance on Tuesday. The Partnership for Safe Medicines, a not-for-profit with deep ties to PhRMA, is scheduled to meet with OMB officials Jan. 7.
However, OMB has not held any publicly disclosed meetings on a proposed rule that is expected to outline the approval process for importing drugs from Canada. The regulatory agenda released last week indicated the administration expects to release the proposed rule on drug imports in January.
A source familiar with the policy said that the administration may not have to wait for rules to be finalized to begin approving state import programs. The rulemaking process could take years and would likely extend until after the 2020 election.
Maine initiated a formal plan for its importation program on Nov. 15 and HHS Commissioner Jeanne Lambrew said Maine does not want to wait for federal rulemaking to develop a plan and submit it for approval, the Bangor Daily News reported.
Colorado officials plan to deliver the state's importation proposal by Jan. 15.
Other states are also looking to create their own importation programs in the next legislative session.
Lawmakers in the Michigan state House and Senate have introduced bills that would create a Canadian-drug importation program for the state's 2020 legislative session. Democrats in New Hampshire included importation in a legislative package several state senators filed on drug pricing, and Connecticut state lawmakers from both parties have expressed interest in reviving importation legislation that stalled in 2019.
Dan Feltes, the New Hampshire Senate majority leader and a Democratic gubernatorial candidate in 2020, introduced a bill that would allow the state to import Canadian drugs that is based on Vermont's legislation. Feltes said he is hopeful for federal prospects on drug importation whether Trump wins or a Democratic challenger prevails. All of the leading Democratic presidential candidates have expressed support for drug importation and it has been a priority for Trump, though Feltes said he generally does not place much confidence in the president's statements.
"I'm hopeful this may be one of his commitments (Trump) would follow through on, or that a new president actually moves forward on that," Feltes said.
Trish Riley, executive director of the National Academy of State Health Policy, said many additional states are interested in importation, but are waiting to see how the four current test cases play out. The academy is helping states develop drug importation proposals and tracking drug-pricing legislation across the country.
"They don't know what to expect. Everybody is waiting to see what happens," Riley said.