HHS opens pathway to importing Canadian drugs

Regulatory NewsRegulatory News | 25 September 2020 |  By 

The US Department of Health and Human Services (HHS) has issued a final rule that clears a path for importation of some Canadian drugs into the US. The measure follows a 24 July 2020 executive order issued by President Donald Trump that directed the HHS secretary to take action to expand access to lower-cost imported drugs.

In a 24 September press release, the US Food and Drug Administration (FDA) said that the final rule would help affordability of drugs for US patients. “Today’s action is an important part of FDA’s priorities to promote choice and competition,” said FDA Commissioner Stephen M. Hahn, MD, in the press release. “The Safe Importation Action Plan aims to clearly describe procedures to import drugs that would lower prices and improve access while also maintaining the high quality and safety Americans expect and deserve.”
The final rule allows states, Indian tribes and potentially pharmacies and wholesalers to seek FDA authorization of importation programs. These Section 804 Importation Programs (SIPs) are designed to allow some prescription drugs that are approved in Canada to be imported to the US, if they are relabeled for US use and undergo statutory testing.
According to the final rule, SIP importation is only allowable if the program can demonstrate “significant cost reductions” to the American consumer. Some of the most expensive prescription therapeutics on the market, biological products, are excluded from the rule’s definition of “eligible prescription drug.” Controlled substances, intravenously injected drugs, inhaled anesthetics and other surgical inhaled drugs, and infused drugs are all also excluded.
Drugs approved by Health Canada’s Health Products and Food Branch (HPFB) are SIP-eligible, if they also meet all conditions other than country-specific labeling for approval under a new drug application (NDA) or abbreviated new drug application (ANDA). “Essentially, eligible prescription drugs are those that could be sold legally on either the Canadian market or the American market with appropriate labeling,” according to the final rule.
SIP sponsors will initially identify one foreign seller and importer, but with a strong track record, sponsors will be able to submit supplemental proposals for additional sellers and importers. However, each SIP supply chain must consist of one manufacturer, one foreign seller and one importer according to the rule. SIPs must also have a written recall plan, and other post-importation reporting requirements.
US Food Drug and Cosmetics (FD&C) Act provisions still apply, including the requirement for foreign sellers to employ section 804 serial identifiers (SSIs) for each package and homogenous case of drugs, among other requirements.
Although the final rule speculates that “As SIP Sponsors and Importers realize savings in acquiring eligible prescription drugs and pass some of these savings on to consumers, it is possible that U.S.-based drug manufacturers may experience a transfer in U.S. sales revenues to these parties,” the rule also notes that “We are unable to estimate the cost savings from this final rule” because the size and scope of SIPs is unknown, as are the specific drugs that may be imported and how much less expensive they may be.
The final rule will be implemented 60 days from its issuance; it can be rescinded if FDA finds that monitoring the SIP program is too burdensome, or if the program does not lower drug costs in the end.
Final rule



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Tags: Canada, FDA, HHS, US

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