Another Week, Another Missive on BPCIA Exclusivity

January 26, 2011

By Kurt R. Karst –      

In yet another letter to FDA Commissioner 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.”  The January 24th letter, which according to a press release, was led by Sen. Sherrod Brown (D-OH), was signed on to by Sens. John McCain (R-AZ), Charles Schumer (D-NY), and Tom Harkin (D-IA).  The letter is the latest in a string of letters concerning BPCIA reference product exclusivity – see our previous posts here, here, and here – and 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 § 351(k)(7)(A)-(B) creating periods of both data and market exclusivity. 

According to the January 24th letter:

As Senators who were actively involved in the debate over the [BPCIA], we are extremely concerned about possible misinterpretations – whether intended or unintended – that could further delay the availability of generic biologic drugs, restricting access for many Americans and driving up costs for the federal government.

The letter goes on to request that FDA “disregard any interpretation that would result in further delay of the availability of generic biologic drugs.”  Making a thinly-veiled reference to recent submissions to FDA supporting an interpretation of the BPCIA’s reference product exclusivity provisions that some argue would delay generic competition, the bipartisan group of U.S. Senators states:

It has recently been brought to our attention that the FDA has received suggested statutory interpretations which, if implemented by the FDA, could result in generic competition being delayed well beyond the 12 year exclusivity period in [sic] statute.  We believe the statute is clear that the FDA can begin reviewing biogeneric applications during the 12 year exclusivity period.

What response will the latest salvo elicit . . . if any?   We’ll keep you posted.