The Office of Management and Budget is reviewing a rule that would allow the U.S. to import certain drugs from Canada and other countries as a strategy to lower drug costs, according to Regulatory Focus.
The specific details of the rule and how long it will take the budget office to conduct the review aren't clear.
President Donald Trump initially unveiled an importation plan in July that would allow the U.S. to import drugs from Canada.
If finalized, the rule would allow states, wholesalers or pharmacists to submit plans for demonstration projects to import medicines from Canada, according to Regulatory Focus.
The plan unveiled in July does have limitations, including that only facilities manufacturing the active pharmaceutical ingredient for the FDA-approved version would be allowed to import drugs. It also has importation exclusions, such as no costly biologics or infused or injected drugs.
The limitations and exclusions make it difficult to know which drugs would be allowed to be imported and how much money the plan could save.
The budget office is also reviewing an FDA draft guidance that was included in the plan released in July that would allow drugmakers to voluntarily import U.S. versions of drugs sold in foreign countries at a lower price.
Top pharmacy lobbying groups Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization have opposed importing drugs from other countries, saying it is potentially dangerous, according to Regulatory Focus.
Pharmacists in Canada have also raised concerns that allowing imports would create drug shortages or raise costs for Canadians.
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