The Biden administration聽said Friday it has no timeline on聽whether聽it will聽allow聽states聽to import drugs from Canada,聽an effort聽that was approved聽under President Donald Trump as a key strategy to control costs.聽
Six states聽have passed laws to聽start聽such聽programs,聽and Florida, Colorado and New Mexico are the furthest along聽in plans聽to get federal approval.聽聽聽
The Biden administration said聽states still have several hurdles to get through,聽including a review by the Food and Drug聽Administration,聽and聽such efforts聽may face pressures from the Canadian government, which聽has warned its drug industry not to聽do anything that聽could聽cause聽drug shortages聽in that country.聽聽
鈥淎lthough two proposals have been submitted to FDA, no timeline exists for the agency to make a decision. Thus, the possible future injuries to Plaintiffs鈥� members are overly speculative and not imminent,鈥� the Biden administration wrote in聽a court filing聽late Friday seeking to dismiss a lawsuit from the Pharmaceutical Research and Manufacturers of America, an industry trade group. Drugmakers are asking the court to overturn the rule set by the Health and Human Services Department in October that for the first time approved allowing states to import drugs from Canada.
The Biden administration said the lawsuit was moot because it鈥檚 unclear when or if any states would get an importation plan approved.聽聽
Drug importation has been hotly debated for decades,聽with many states and advocates believing it would help lower聽the prices聽Americans pay聽while聽the聽drug industry聽contends聽it聽would undercut聽the safety of聽the U.S. drug supply. Critics note most聽brand-name drugs sold in the U.S. are manufactured abroad.聽
Friday鈥檚 court filing聽had been eagerly anticipated,聽as it was the first time the Biden administration weighed in on the issue. Promises to curb high drug prices have聽been a standard sound bite of political campaigns, and importation enjoys聽. Supporters of importation range the political spectrum from聽progressive聽Sen.聽Bernie Sanders聽(I-Vt.)聽to聽Florida鈥檚聽conservative聽Republican聽governor,聽Ron DeSantis. They argue聽Americans should not聽pay聽more for drugs than consumers in other countries.聽
Rachel Sachs, a health law expert at聽Washington University聽in St. Louis, said聽the rhetoric in the court filing is probably 鈥渄isheartening鈥� to DeSantis and other supporters hoping states鈥櫬爄mportation programs聽would be approved soon. 鈥淭hey are laying out that there is no time limit on the FDA and there are many steps that states have to undergo before approval,鈥澛爏he said.聽
Supporters of drug importation say they still have hope, especially if the court agrees to the administration鈥檚 effort to throw out the suit.聽
鈥淲hile articulating possible hurdles that may prevent state drug importation programs from moving forward, the Biden administration鈥檚 motion to dismiss PhRMA鈥檚 lawsuit keeps alive opportunities for more Americans to benefit from drug importation,鈥� said Gabriel Levitt,聽president of聽Pharmacychecker.com, which聽verifies聽online聽foreign pharmacies for customers.聽
Importing drugs from Canada, where聽government controls keep prices lower, has been debated for decades in the聽U.S. A 2003 federal law gave the executive branch permission to聽do it,聽but only if certified as safe and cost-effective by the聽HHS聽secretary.聽Then-HHS Secretary Alex Azar聽announced聽in聽September聽that聽he would become聽the first to do that,聽and the department issued聽its聽rule聽in October.聽聽
Florida, Colorado, Maine,聽New Hampshire,聽New Mexico聽and聽Vermont聽are pursuing efforts to import drugs.聽
笔丑搁惭础听聽in November聽in the聽U.S. District Court for the District of Columbia.聽In聽the聽court filing late Friday, the Biden聽administration聽said聽the聽FDA could reject state importation plans for many reasons,聽including safety concerns and lack of聽significant聽savings聽for consumers.聽
In an emailed聽statement,聽PhRMa spokesperson Nicole聽Longo said: 鈥淲e continue to believe the Trump Administration violated federal law when it finalized its rule permitting state-sponsored drug importation from Canada without proper certification and, in doing so, putting the health and safety of Americans in jeopardy.鈥澛�
颁补苍补诲补听丑补蝉听聽to send its drugs to the United States, fearing it could exacerbate shortages聽there.聽Last year,聽Canadian health regulators聽聽against exporting any drugs that聽could lead to shortages.聽
During the presidential campaign,聽Joe聽Biden supported聽drug importation.聽His聽HHS聽secretary, Xavier Becerra, voted for the 2003 Canadian drug importation law聽as聽a member of Congress.聽
In most circumstances, the FDA says聽it鈥檚聽illegal for individuals to import drugs for personal use.聽
Yet, for nearly 20 years, storefronts in Florida have helped people buy drugs online from pharmacies in Canada and other nations at typically half the聽U.S. price. The FDA has periodically cracked down on the operators but has allowed the stores to stay open.聽
The Florida legislature in 2019 approved the state drug importation program,聽and the state submitted its proposal to聽the聽federal government last year. While DeSantis has boasted of the strategy at聽news聽conferences in聽the聽retiree-heavy community of The Villages, the state program would have little direct聽effect on聽most Floridians.聽
That鈥檚聽because the state effort is geared to getting聽lower-cost drugs to state agencies聽for prison health programs and other needs and for聽Medicaid, the state-federal health program for the poor. Medicaid enrollees already pay little or nothing for medications.聽
Florida has identified about 150 drugs聽鈥斅爉any of them expensive HIV/AIDS, diabetes and mental health medicines聽鈥斅爐hat it plans to import. Insulin, one of the most expensive widely used drugs, is not included in the program.聽
DeSantis said the importation plan would save the state between $80聽million聽and $150 million. The state has聽a $96 billion budget, he said.聽
鈥淚t鈥檚 been under review enough,鈥� DeSantis said Friday,聽hours before聽the聽Biden administration鈥檚聽court filing. 鈥淲e have followed every regulation. We鈥檝e met every requirement that we were asked to meet, and we want now to be able to get this final approval so that we can finally move forward.鈥澛�
Christina Pushaw, a spokesperson for DeSantis, said the governor was disappointed聽by the Biden court filing.聽
鈥淕overnor DeSantis calls on the Biden Administration to step out of the way of innovation and act immediately to approve Florida鈥檚 plan that provides safe and effective drugs to drive down prescription costs,鈥� she said in an email to KHN.聽
The governor appeared at LifeScience Logistics in Lakeland, Florida,聽where state regulators worked with the company to construct an FDA-compliant warehouse to process pharmaceuticals from Canada.聽
鈥淲e鈥檙e ready, willing and able,聽and I think that this could be really, really significant,鈥� DeSantis said.聽
He said the warehouse could begin receiving drugs from Canada within 90 days聽if聽the state聽were to get approval from Washington.聽
LifeScience Logistics officials said they are working with Methapharm Specialty Pharmaceuticals, which has offices near Toronto and Fort Lauderdale, Florida,聽to act as its Canadian wholesaler. Quality checks would be done on the drugs in Canada and again in Florida, said Richard Beeny, CEO of LifeScience Logistics.聽聽
LifeScience聽has begun early talks on聽negotiating prices with drug manufacturers that聽would聽deliver medications to聽Methapharm,聽which in turn聽would聽send drugs to the Lakeland warehouse. 鈥淭here is broad interest in the program,鈥� Beeny said about drug companies wanting to participate. 鈥淏ut the pending suit is a bit of a roadblock,聽so we have to wait and see how that pans out.鈥澛�
Unlike Florida鈥檚 plan, Colorado鈥檚 Canadian importation program would help individuals buy the medicines at their local pharmacy. Colorado also would give health insurance plans the option to include imported drugs in their benefit designs.聽
Mara Baer, a health consultant who has worked with Colorado on its proposal, said the Biden decision leaves open the question聽of whether state importation plans might eventually be approved.聽鈥淗HS could聽have let the rule fall and they did not, which is important given the challenges facing Congress in moving major drug pricing reform in the short term,鈥� she said.聽