FDA’s Proposed Rule on Drug Importation Lands at OMB

Regulatory NewsRegulatory News | 04 November 2019 |  By 

The Office of Management and Budget (OMB) is now reviewing a proposed rulemaking from the US Food and Drug Administration (FDA) to allow certain medicines to be imported from Canada and other countries outside the US as a cost-saving measure.

What exactly the proposal looks like and how long it will take OMB to conduct its review has yet to be understood, although FDA put out a plan for the rulemaking in July, following interest from Florida and other states to lower their pharmaceutical bills.

Joe Grogan, assistant to President Donald Trump, said at a conference in October that Florida wants importation and FDA will likely find a way. Trump similarly said that importation is coming soon.

According to FDA’s plan, the rule, once proposed and finalized, will allow Florida and other states, wholesalers or pharmacists to submit plans for demonstration projects to import medicines from Canada. However, the proposal is expected to have several key 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.

OMB is also reviewing a draft guidance from FDA, also discussed in the plan from July, that would allow manufacturers to voluntarily import US versions of drugs sold in foreign countries, potentially at a lower price.
Industry groups PhRMA and BIO have opposed the importation measures, calling them potentially dangerous. Pharmacists in Canada and others within Health Canada have also expressed concerns in recent weeks that allowing such imports could create shortages or raise costs for Canadians.

And curiously, neither the planned proposed rule nor the planned guidance is listed as having an “international impact,” which according to OMB means the regulation “is expected to have international trade and investment effects, or otherwise may be of interest to the Nation's international trading partners.”

Importation of Prescription Drugs Proposed Rule at OMB


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