US FY 2014 budget continues push to curb patent settlements, shorten biologics exclusivity; a lawyer's view

At first look, the US Food and Drug Administration  appears to have fared rather well under President Barack Obama’s recent Fiscal 2014 Budget proposals (The Pharma Letter April 11), with an additional $821,453,000 in total funding, notes Kurt Karst, writing on law firm Hyman, Phelps & McNamara’s FDA Law Blog.

However, he notes, most of the increase is due to new user fee revenue, making the increase a bit of an illusion. In previous budgets the Obama Administration has proposed a ban on drug patent settlement agreements (an issue that the US Supreme Court is currently considering), as well as shortening the 12-year period of reference product exclusivity for brand-name biological products created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA). These topics are both address in the latest budget proposal

According to the Obama Administration, banning drug patent settlement agreements and shaving five years off of reference product exclusivity (from 12 years to seven years) will save US taxpayers $14.28 billion between 2014 and 2023.