On December 18, the Trump administration's Food and Drug Administration (FDA) issued a proposed rule and draft guidance to let states and drug makers import lower-cost prescription drugs from other countries. The proposed rule allows states, along with wholesalers, pharmacies and certain other non-federal governmental entities to import certain drugs from Canada through FDA-approved importation programs while accompanying draft guidance for industry allows drug makers to import their own drugs initially intended for distribution abroad. The pair of proposals are key pieces of the administration's remaining drug pricing agenda focused on bringing down prices for American consumers, following its retreat on several more ambitious drug pricing proposals, such as a plan to dramatically reform the drug rebate system. This proposal also comes just a week after passage of the House Democrat's sweeping proposal (H.R. 3) to allow Medicare to negotiate the price of high-cost prescription drugs and amid negotiation surrounding several other larger drug pricing packages aimed at delivering lower drug prices demanded by American voters.

The attached Tax Alert has details.

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ATTACHMENT

Importation proposed rule