Nisha Quasba Discusses Trump’s Push to Boost Drug Imports in Bloomberg Law

Faegre Drinker Consulting director Nisha Quasba commented on Trump’s push to buy more drugs from abroad to lower pharmaceutical prices in an article by Bloomberg Law.

The publication reported that President Trump issued an executive order pushing drugmakers to bring U.S. prices for pharmaceuticals, the highest in the world, in line with what other countries pay. The order directs the U.S. Food and Drug Administration (FDA) to explore situations in which the agency could consistently grant waivers “to import prescription drugs on a case-by-case basis from developed nations with low-cost prescription drugs.”

The order suggests the FDA will “more actively use Section 804 waivers to certify the safety of personal drug importation,” said Quasba. Personal importation of prescription drugs is generally prohibited, but Section 804 allows the FDA to grant to individuals, either “by regulation or on a case-by-case basis, a waiver of the prohibition of importation of a prescription drug or device or class of prescription drugs or devices,” she added.

The federal agency may publish guidance describing circumstances where it may consistently grant waivers to allow personal importation. But “no current system exists to approve these waivers—one would need to be established,” Quasba said.

The full article is available to Bloomberg Law subscribers.