Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas

Regulatory NewsRegulatory News | 31 July 2019 |  By 

As part of plans to lower the cost of prescription drugs, the US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) on Wednesday released preliminary plans to create two new pathways to import pharmaceuticals.

The first pathway will allow states, wholesalers or pharmacists to submit plans for demonstration projects to import medicines from Canada under a Notice of Proposed Rulemaking (NPRM) from HHS that has yet to be released. And the NPRM is expected to propose several limitations (i.e. only facilities that also manufacture API for the FDA-approved version would be allowed) and exclusions (no costly biologics, drugs with a REMS or infused or injected drugs) that may raise further questions about what drugs would actually be imported and how much could be saved.

Pharmacists in Canada and others within Health Canada have expressed concerns in recent weeks that allowing such imports could create shortages or raise costs for Canadians.

The second pathway, meanwhile, would mandate new guidance from FDA that allows manufacturers to voluntarily import US versions of drugs sold in foreign countries, potentially at a lower price. This pathway could be used to import cheaper versions of insulin or cancer medicines.

“If costs can be lowered significantly through this pathway, there may be reduced need for the demonstration projects outlined in Pathway 1,” the HHS plan says.

HHS Secretary Alex Azar, who has previously called drug importation a “gimmick,” also said Wednesday that he did not discuss the new importation plans with industry.

PhRMA president and CEO Stephen Ubl said in a statement: "The Administration’s importation scheme is far too dangerous for American patients. There is no way to guarantee the safety of drugs that come into the country from outside the United States’ gold-standard supply chain. Drugs coming through Canada could have originated from anywhere in the world and may not have undergone stringent review by the FDA."

BIO president Jim Greenwood also said in a statement: “This is a misguided attempt to keep a ill-informed campaign promise.”

And in a reversal from previous FDA leadership, Acting Commissioner Ned Sharpless on Wednesday pledged his support for the two pathways.

“The Safe Importation Action Plan is the result of the hard work by dedicated FDA staff in close collaboration with HHS & the White House. We’re keenly focused on ensuring the importation approaches outlined pose no additional risk to the public’s health & safety,” Sharpless said.

Last July, FDA said it would work to develop a policy to facilitate the importation of certain sole-source drugs.

Safe Importation Action Plan


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