Morrison & Foerster partner Bethany Hills discussed with BioWorld the increase in FDA approvals of abbreviated new drug applications, including first-time generics.
“This is clearly part of the overall Trump administration’s drug pricing plan,” Bethany said, adding that increasing the availability of generics “does seem to be the easiest to accomplish through the existing regulatory framework. And it does seem to be the one drug pricing component…that has an economic model behind it that makes sense.”
Bethany also noted a significant amount of government work being done in terms of “enforcing the competition laws and trying to minimize the pay-for-delay situation or other activities that could be used to minimize the generic entry on the market.”