On Might 21, FDA introduced “enhancements” to the Part 804 import program (SIP). Part 804 of the Federal Meals, Drug, and Beauty Act offers a pathway for sure prescription drug imports from Canada. The FDA information launch offers that FDA is providing to pre-review SIP proposals and meet with particular person states and tribes to supply preliminary suggestions on the proposal, with the aim of lowering burden on the state or tribe. FDA additionally introduced that it’s working to develop a “user-friendly” device to assist states in growing proposals and that it’s going to help states with choices to streamline the required price financial savings evaluation that have to be included in such proposals.
The announcement comes a bit over a month after President Trump’s April 15 Government Order (EO), “Reducing Drug Costs by As soon as Once more Placing People First. That EO supplied that inside 90 days, “the Secretary, by way of the Commissioner of Meals and Medication, shall take steps to streamline and enhance the Importation Program underneath part 804.” Presumably, the enhancements famous in FDA’s information launch are meant to fulfill this goal.
Whereas making a person pleasant device and growing choices to streamline the price financial savings evaluation could help with expediting state SIP proposal submissions, there are nonetheless a number of hurdles for states and tribes to recover from earlier than really having the ability to import prescribed drugs from Canada. After the SIP proposal submission, FDA should first authorize the SIP proposal. From there, the state/tribe should submit a Pre-Import Request to FDA inside twelve months of the SIP authorization. That Pre-Import Request, which requires intensive data, have to be granted by FDA earlier than imports can happen.
Whereas we’re conscious of not less than 5 states which have submitted SIP proposals to FDA, just one state, Florida, has acquired FDA authorization. FDA licensed Florida’s SIP proposal in January 2024, three years after the SIP proposal had been submitted to FDA and after Florida filed a lawsuit over FDA’s failure to answer Florida’s FOIA request for information concerning its proposal. Regardless of being a motivated social gathering, Florida nonetheless has not begun importing prescribed drugs from Canada. Shortly after the SIP was licensed, we famous the numerous hurdles that remained earlier than Florida may start to import. In December 2024, FDA granted Florida a six-month extension to submit its Pre-Import Request.
The Florida case raises actual questions on whether or not the actions introduced right this moment, even when they scale back the timelines for SIP proposal submissions, will meaningfully influence the general timeline for states to start importing medicine from Canada.
