Amid multiple efforts to rein in steep drug costs in the U.S., Colorado has received the all-clear to take matters into its own hands, albeit through a framework that may be difficult to pull off in the real world.\u00a0<\/p>\n
Early this week, the FDA approved<\/a> (PDF) Colorado\u2019s multi-year bid to import lower-cost branded drugs from Canada. The authorization will last for a span of two years and now permits the state to submit so-called pre-import requests to the FDA for specific products, according to a letter from the regulator sent to the state\u2019s executive director of healthcare policy on June 15.\u00a0<\/p>\n After first exploring the idea in 2019, Colorado joined<\/a> a number of other states seeking federal permission to import cheaper medicines from Canada in late 2022, following in the footsteps of Florida, New Hampshire and New Mexico. A little over a year later, Florida became the first state\u2014and until now the only other one\u2014to receive formal sign-off<\/a> on the strategy from the FDA.\u00a0<\/p>\n Florida\u2019s import approval drew backlash from industry groups on both sides of the northern border, with critics flagging the potential impact to Canadian drug supply and numerous implications for manufacturers. Meanwhile, the program has faced a harsh reality check since winning FDA clearance, with Florida\u2019s public health agency having failed to get the program off the ground<\/a> as of February, according to Politico and other sources.\u00a0<\/p>\n While describing the new import approval as a \u201ctremendous step toward making prescription drugs affordable for all Coloradans,\u201d the state, in a press release, alluded<\/a> to potential hurdles ahead, noting that it \u201cstill faces the critical issue of procuring a supply of eligible drugs from manufacturers\u201d and further urging \u201cour federal partners to take a productive role in facilitating manufacturer cooperation with the program.\u201d\u00a0<\/p>\n The program has the potential to save patients in Colorado some $46 million over three years through lower insurance premiums and out-of-pocket expenses, should a steady supply of drugs from up north be achieved, per the release.\u00a0<\/p>\n Colorado has outlined<\/a> (PDF) 20 branded meds in particular that it\u2019s hoping to improve access to via the import program. The list covers a range of drugs, from Gilead\u2019s HIV treatment Biktarvy and Bristol Myers Squibb\u2019s blood thinner Eliquis to Novo\u2019s Ozempic, AbbVie\u2019s Rinvoq and Vertex\u2019s triple therapy combo for cystic fibrosis, Trikafta, among others.\u00a0<\/p>\n The state added in its announcement that it is \u201cable to work with all willing manufacturers on more than just these drugs to bring savings to Coloradans.\u201d\u00a0<\/p>\n One key roadblock that potentially stands in the way of Colorado\u2019s plan\u2014as it has for Florida\u2019s\u2014is that Canada is unwilling to pass on supplies of medicines if it could put inventories for its own patients in short supply.\u00a0<\/p>\n In February of 2024, shortly after Florida received sign-off on its Canadian import scheme from the FDA, Health Canada clarified<\/a> that it has \u201cregulatory safeguards\u201d in place to preserve the nation\u2019s drug supply, including by \u201cprotecting our supply from foreign bulk importation programs.\u201d\u00a0<\/p>\n The Canadian government added at the time that its \u201cposition is that importing large quantities of drugs intended for the Canadian market is not a solution to high drug prices in other countries.\u201d Drugs meant for Canada cannot be sold or exported for use in other countries if it would cause or worsen a shortage back home, the government warned.\u00a0<\/p>\n Another hitch will likely come in the form of securing pharma company buy-in, and recent trade disputes between the U.S. and Canada could further scupper any potential cooperation, Stacie Dusetzina, a professor at the Vanderbilt University School of Medicine, told<\/a> Stat News regarding the Colorado program.<\/p>\n Meanwhile, the FDA nod “doesn\u2019t solve the core problem for Colorado,” which is namely that “state importation programs from Canada pose a serious danger to public health, and there\u2019s no evidence these programs deliver savings for patients,” Reid Porter, a spokesperson for the U.S. industry trade group PhRMA, told Fierce in an emailed statement.\u00a0<\/p>\n Porter continued that “Florida remains the only other state with authorization, but its program has stalled in part because Canadian manufacturers declined to participate over concerns about protecting Canada\u2019s drug supply.\u201d<\/p>\n While the issue of high prescription drug costs has long been a bipartisan rallying cry for U.S. politicians, the issue has seen more substantial policy movement over the last few administrations, both in the form of the Biden-era Inflation Reduction Act\u2014which teed up Medicare price negotiations on certain high-spend medicines\u2014and President Donald Trump\u2019s \u201cmost favored nation\u201d pricing policies, which seek to align U.S. drug costs with those in certain comparator countries.\u00a0<\/p>\n The Trump administration last week floated a proposal<\/a> to make Medicare pricing negotiations established via the IRA permanent, and multiple Big Pharma companies have fallen in line with the President\u2019s MFN push, too, inking high-profile deals<\/a> with the White House that outline discounts on select meds and lower pricing pledges on future U.S. launches in exchange for tariff immunity and other potential perks.\u00a0<\/p>\n