FDA spells out rules for states seeking to import drugs from Canada

 The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

For instance, there’s a long list of drugs that will be excluded from all state importation plans, including all biologics, which are generally some of the most expensive drugs, as well as controlled substances, infused drugs, and drugs that are injected intravenously (into a vein), intrathecally (into the spinal fluid), or intraocularly (into the eye), and drugs that are subject to a risk evaluation and mitigation strategy, among others.

An FDA spokesperson confirmed to Endpoints News last month that a meeting on March 31 was the first opportunity for FDA and HHS to discuss import plans with states that have taken significant action toward developing their proposals, which currently include Florida, Colorado, Maine, New Mexico and Vermont.

Florida Gov. Ron DeSantis has been at the forefront of this push as he’s spent months lamenting the FDA’s slowness in responding to state plans and he previously signed a bill in 2019 creating the framework to begin importing. He has since promised that Florida could potentially save between $80 million and $150 million from the imports in the first year alone.

But the devil will be in the details of how states can show the math on these steep cost reductions, particularly as Canadian health officials have made clear their opposition to these imports in recent years, and as there may be further export restrictions.

Canada’s former acting ambassador told Trump officials back in 2019 that “it is important to recognize that Canada’s market for pharmaceuticals is too small to have any real impact on US drug prices.”

Meanwhile, Canada also established a system where certain drugs intended for the Canadian market are banned from distribution outside the country if the sale “would cause or worsen a drug shortage.”

And the FDA has made clear in a slide deck on such state proposals, that the issue of cost reductions will be a factor as states will have to show how their proposals “will result in a significant reduction in the cost to the American consumer.”

An HHS senior economist Aaron Kearsley also previously presented slides to states, emphasizing that state proposals should include all costs associated with implementing the plans, including “importer price markups – Other transportation and logistical costs not captured by the importer price markup – Costs associated with drug samples, testing, and other requirements under Section 804 and the Importation of Prescription Drugs Final Rule.”

Furthermore, importation plans must include relabeling plans as the Canadian drugs have to be converted to US labels, and the FDA is requesting side-by-side comparisons of the FDA-approved labeling and the proposed labeling with all differences annotated and explained.

Meanwhile, further restrictions may again curtail what drugs are included in such proposals as the final rule requires manufacturers or importers to test the incoming drugs for authenticity, degradation, and to ensure that the eligible prescription drugs are in compliance with established specifications and standards.

“The results of this testing will be subject to review and acceptance by FDA,” the Q&A guidance says.

The final rule also requires that the foreign seller be licensed to wholesale drugs by Health Canada and registered with FDA as a foreign seller, but it “cannot have an international pharmacy license that allows it to distribute drugs that are approved by countries other than Canada and that are not HPFB-approved for distribution in Canada.”

FDA further explained that while it may use a phased review process for evaluating state import proposals that do not identify a foreign seller initially, state plans cannot be authorized by FDA without a foreign seller.

The Biden administration previously sought to dismiss a PhRMA lawsuit last summer seeking to stop the imports, although the result of that suit remains unknown.

The FDA also made clear that while the final rule governing these import programs does not provide a timeframe for reviewing a state’s proposal, the timeframe for review “is dependent upon the inclusion of all requirements of the rule” and the FDA expects to provide feedback on a proposal’s adherence to the requirements within six months from submission.

https://endpts.com/fda-spells-out-the-rules-and-restrictions-for-states-seeking-to-import-drugs-from-canada/