![\"\"](\"https:\/\/lakelandgazette.info\/news\/wp-content\/uploads\/2024\/01\/download-1-1024x576.jpeg\")
<\/figure>\n<\/div>\n\n\nThe federal agency approved the importation program for two years, saying Florida had met requirements to show that it \u201cwill significantly reduce the cost of covered products to the American consumer without posing additional risk to the public\u2019s health and safety.\u201d<\/p>\n\n\n\n
The plan is designed to make imported drugs available in government programs such as Medicaid, the prison system and facilities run by the Florida Department of Children and Families. At least initially, the state wants to import drugs to treat conditions such as HIV and AIDS and mental illness.<\/p>\n\n\n\n
Friday\u2019s approval came after lengthy wrangling about the plan and the state filing two lawsuits against the FDA.<\/p>\n\n\n\n
\u201cThey have set up a number of hoops,\u201d state Agency for Health Care Administration Secretary Jason Weida told the House Health Care Appropriations Subcommittee last month. \u201cWe have jumped through them all.\u201d<\/p>\n\n\n\n
Gov. Ron DeSantis and then-Florida House Speaker Jose Oliva, R-Miami Lakes, made the drug-importation issue a priority in 2019, with lawmakers approving the idea. The state submitted a proposal in November 2020 to the FDA.<\/p>\n\n\n\n
That touched off a review process that included the FDA seeking revisions to the plan. The state filed a revised proposal in October to try to address the federal agency\u2019s concerns, according to court documents.<\/p>\n\n\n\n
As an example of issues that emerged during the back-and-forth, the FDA in an Aug. 14 letter pointed to Florida\u2019s proposal lacking a secured warehouse within 30 miles of an \u201cauthorized port of entry\u201d for prescription drugs in Canadian importation programs. The only authorized port of entry was Detroit, while Florida planned to store shipments at a facility in Whitestown, Ind.<\/p>\n\n\n\n
A news release posted on the FDA website described Friday\u2019s approval as a \u201cfirst step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada.\u201d<\/p>\n\n\n\n
Before importation can start, the Agency for Health Care Administration has to meet conditions, such as submitting additional \u201cdrug-specific information\u201d for FDA approval, the news release said.<\/p>\n\n\n\n
Also, the news release said the Agency for Health Care Administration will have to ensure \u201cthat the drugs Florida seeks to import have been tested for, among other things, authenticity and compliance with the FDA-approved drugs\u2019 specifications and standards.\u201d<\/p>\n\n\n\n
As the FDA review continued in 2022, the state filed a lawsuit alleging violations of the federal Administrative Procedure Act and the Freedom of Information Act. The Administrative Procedure Act allegations centered on delays in the decision-making, while the Freedom of Information Act allegations involved records that the state sought from the FDA.<\/p>\n\n\n\n
The state filed another Freedom of Information Act lawsuit in 2023. Both cases remain pending in federal court in Tampa.<\/p>\n","protected":false},"excerpt":{"rendered":"
By Jim Saunders NEWS SERVICE OF FLORIDA Almost five years after Florida began pursuing the idea, the U.S. Food and Drug Administration on Friday approved a plan that will allow… <\/p>\n","protected":false},"author":2,"featured_media":40720,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"wpai_generated_summary":"","footnotes":"","jetpack_publicize_message":"{title}\n\n{excerpt}\n\n{url}","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"dois","default_image_id":71799,"font":"","enabled":false},"version":2},"_wpas_customize_per_network":false},"categories":[14],"tags":[7204],"class_list":["post-40719","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-fda-approves-plan-for-florida-to-import-cheaper-prescription-drugs-from-canada"],"jetpack_publicize_connections":[],"_links":{"self":[{"href":"https:\/\/lakelandgazette.info\/news\/wp-json\/wp\/v2\/posts\/40719","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lakelandgazette.info\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lakelandgazette.info\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lakelandgazette.info\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/lakelandgazette.info\/news\/wp-json\/wp\/v2\/comments?post=40719"}],"version-history":[{"count":0,"href":"https:\/\/lakelandgazette.info\/news\/wp-json\/wp\/v2\/posts\/40719\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lakelandgazette.info\/news\/wp-json\/wp\/v2\/media\/40720"}],"wp:attachment":[{"href":"https:\/\/lakelandgazette.info\/news\/wp-json\/wp\/v2\/media?parent=40719"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lakelandgazette.info\/news\/wp-json\/wp\/v2\/categories?post=40719"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lakelandgazette.info\/news\/wp-json\/wp\/v2\/tags?post=40719"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}