This has been a long time coming and perhaps the impetus was Florida’s suit against the FDA for taking so long to authorize the program, but now the fun begins. The letter to the Secretary of the Florida Agency for Health Care Administration authorizing the Canadian drug import program (here) provides a laundry list of activities that must be undertaken prior to the first import and a series of reporting requirements that will follow.

The unanswered question is how Canada will react if the importing of drugs from that country winds up causing shortages of the imported products in Canada. Florida has a very large elderly population and, while its citizens will benefit from lower prices (something that had to be demonstrated in the import application process), it is certainly possible that the program will be a bellwether for how other states (if authorized) will impact the Canadian drug supply.

To start off, first, “[T]he Importer submits a complete Pre-Import Request to FDA, by email to SIPDrugImportsandRFP@fda.hhs.gov, at least 30 calendar days before the scheduled date of arrival or entry for consumption of a shipment containing an eligible prescription drug covered by the SIP, whichever is earlier.”

The second requirement is, “[T]he manufacturer or the Importer conducts testing of the eligible prescription drugs for authenticity, degradation, and to ensure that the eligible prescription drugs are in compliance with established specifications and standards (i.e., Statutory Testing) in accordance with section 804(e)(1) of the FD&C Act.”

Thirdly the imported must “make the labeling corrections specified in the attachment to this letter.” (See letter and attachment at the link above).

The other requirements also outlined in the letter should be well understood and adhered to in order to assure that the FDA does not cancel the import application. It will be interesting to see how many other states will comply with the FDA requirements to initiate a Canadian importation program for its citizens. It may be years before the impact of this program is fully understood and whether it is a viable alternative to reduce prices for consumers while – and here is the big fish in the pond – assuring safety of the imported drugs.

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Robert Pollock, M.S., is Senior Advisor, Outside Director to the Board at Lachman Consultants. He joined Lachman Consultants following a distinguished career with the FDA and the Public Health Service. His FDA experience, culminating as the Acting Deputy Director of the Office of Generic Drugs, enables him to provide expert advice and assistance on all aspects of FDA and Regulatory filings. Mr. Pollock is well-versed in the intricacies of International Harmonization Issues, regulatory strategies, standards and filing issues, resolution of FDA regulatory matters, as well as in the resolution of patent/exclusivity issues.