Another week, another missive on US BPCIA exclusivity

In yet another letter to US Food and Drug Administration Commissioner Margaret Hamburg concerning the 12-year period of reference product exclusivity (which can be extended to 12.5 years with pediatric exclusivity) created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), a bipartisan group of U.S. Senators expresses concern about how the new statutory provisions could be interpreted and requests that FDA “reject misinterpretations of the law that – if followed – would prohibit the agency from even reviewing generic applications during the 12 year monopoly period, which would preclude generic alternatives from being ready to go to market after the 12-year monopoly period ends,” reports Kurt Karst of US law firm Hyman, Phelps & McNamara on its FDA Law Blog.

The January 24 letter, which according to a press release, was led by Senator Sherrod Brown (Democrat, Ohio), was signed on to by Senators John McCain (Republican, Arizona), Charles Schumer (Dem, New York), and Tom Harkin (Dem, Iowa). The letter is the latest in a string of letters concerning BPCIA reference product exclusivity is most similar in tone and content to the letter signed on to by several generic drug manufacturers and other companies and organizations noting that the BPCIA amended the Public Health Service to add No 351(k)(7)(A)-(B) creating periods of both data and market exclusivity.

According to the January 24 letter: