Will the USA's Hatch-Waxman lock be sprung in 2012? asks HP&M lawyer

In the USA, there have been rumors for several weeks that, once the ball gets rolling in Congress with legislation to reauthorize the various user fee statutes (eg, the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act) and other statutory provisions (eg, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act), along with legislation to create new law (eg, the Generic Drug User Fee Act), there might be a push to open up and amend the Hatch-Waxman Amendments, comments Kurt Karst on law firm Hyman, Phelps & McNamara’s FDA Law Blog.

Although the 2003 Medicare Modernization Act made important changes to Hatch-Waxman, and in particular with respect to Abbreviated New Drug Applications (ANDAs) and 180-day exclusivity, the brand-side of the equation concerning five-year New Chemical Entity (NCE) exclusivity, three-year new clinical investigation exclusivity, and Patent Term Extensions (PTEs) has remained largely untouched since 1984. A new article out this week in Health Affairs might very well be an opening salvo in what could be a battle royal to more broadly open up Hatch-Waxman, says Mr Karst.

The article, authored by Duke University professor emeritus of economics Henry Grabowski and four other co-authors (Margaret Kyle, Richard Mortimer, Genia Long, and Noam Kirson), is titled “Evolving Brand-Name And Generic Drug Competition May Warrant A Revision Of The Hatch-Waxman Act.” Prof Grabowski’s research was supported in part by the Pharmaceutical Research and Manufacturers of America.