The Trump administration proposed a new pilot project to enable states to import drugs from Canada and that would enable drug companies to voluntarily import their products.
The importation proposals “are a historic step forward in an effort to bring down drug prices at out of pocket costs,” Department of Health and Human Services (HHS) Secretary Alex Azar told reporters on a call announcing the proposals.
But the pilot project, announced as a proposed rule by HHS and the Food and Drug Administration (FDA) Wednesday, will not apply to some of the highest-priced drugs such as biologics. The Trump administration originally put out an importation plan back in July.
The proposed rule outlines a pilot project where states and nonfederal government entities would apply to the FDA to import certain prescription drugs from Canada. States can work with wholesalers and pharmacies to develop an application.
The drugs must be approved in Canada. Certain types of drugs are not eligible, including controlled substances, biologics and intravenously injected drugs.
Other drugs that are excluded are any products under a Risk Evaluation and Mitigation Strategy, a safety strategy that the FDA imposes on high-risk products. Some drugs that are also not affected are drugs that would be injected into the spinal column or used in ophthalmic injectables, Azar said.
Eligible drugs would have to be relabeled and undergo testing to ensure they are not degraded, administration officials told reporters during a call announcing the project.
The FDA also released a draft guidance that would allow a drug company to voluntarily import their own product from Canada, where prices are cheaper due to the country’s single-payer program.
There are several states that are chomping at the bit to set up importation programs in a bid to bring drug costs under control. Most notably among them is Florida.
But a major hurdle for any importation program is the Canadian government, which gets drugs at a cheaper price due to its single-payer system. The country’s ambassador told HHS and the White House last month that the market is too small to satisfy Americans’ demand for cheaper drugs.
The ambassador said that Canada represents only 2% of global drug consumption versus 44% for the U.S.