[author: Donald Zuhn]

While the U.S. Food and Drug Administration recently noted that the agency "has been unable to reach a decision" on a Citizen Petition regarding the Biologics Price Competition and Innovation Act (BPCIA) filed by Abbott Laboratories last April, the same cannot be said of California Representative Anna Eshoo, who sent a letter to the FDA expressing her views on Abbott's Petition less than three weeks after the Petition was filed.

Abbott filed the Petition on April 2, asking the agency to refrain from accepting biosimilar applications under the BPCIA that cite reference products (biologics) for which a biologics license application (BLA) was submitted to the FDA prior to March 23, 2010 (see "Abbott Asks FDA to Refuse Certain Biosimilar Applications").  The BPCIA, which provides an approval pathway for biosimilar biological products and constitutes a portion of the Patient Protection and Affordable Care Act that was signed into law on March 23, 2010, allows the FDA to accept biosimilar applications four years after a reference product has been licensed and to approve such applications twelve years after the reference product has been licensed.  In a letter sent to Abbott's counsel earlier this month, the FDA noted that it had "not yet resolved the issues raised in [Abbott's] citizen petition," explaining that the Petition "raises complex issues requiring extensive review and analysis by Agency officials" (see "FDA Continues to Review Abbott Petition on Biosimilars).

In a letter sent to FDA Commissioner Dr. Margaret Hamburg on April 20, Rep. Anna Eshoo (D-CA) provided a quick response to Abbott's Citizen Petition.  Rep. Eshoo (at right), who along with Rep. Jan Inslee (D-WA) and Rep. Joe Barton (R-TX) was one of the principal authors of the BPCIA, noted in her letter that the biosimilars regulatory pathway created by the BPCIA "balance[s] the need for patient access with incentives for innovation . . . by establishing 12 years of data exclusivity for innovator products."  The letter points out, however, that "[t]he BPClA clearly states that this period of exclusivity applies to all biologics and the expiration clock is retroactive" (emphasis added).

Rep. Eshoo writes that "[w]hile Abbott's Citizen Petition argues that pre-BPCIA approved biologic products cannot be subject to the law, l want to state very emphatically that it was Congressional intent for the new pathway to apply to biologics approved before and after the passage of the Affordable Care Act [i.e., March 23, 2010]" (emphasis added).  She notes that Congress "specifically designed the legislation this way in order to allow for immediate and/or impending use of biosimilars by patients at a lower cost and to capture the large savings which could be gained from top-selling biologics losing their exclusivity around time of passage."

Rep. Eshoo closes her letter by stating that:

Abbott's actions undermine the very legislation it supported during Congressional debate on this issue.  They were part of a broad coalition that supported the legislation and they never raised the issue throughout the legislative process.  Retroactive application of the 12 years of exclusivity was a guiding principle of the many discussions about the legislation to which Abbott was a party to every step of the way.

She concludes by urging the FDA to reject Abbott's Petition.

For additional information regarding this and other related topics, please see:

• "FDA Continues to Review Abbott Petition on Biosimilars," October 24, 2012
• "Abbott Asks FDA to Refuse Certain Biosimilar Applications," April 23, 2012
• "Representatives Oppose President's Attempt to Reduce Data Exclusivity Period," October 17, 2011
• "Legislators Urge President to Include 12-Year Data Exclusivity Period in Free Trade Agreement," August 15, 2011
• "House Legislators Lobby to Exclude 12-Year Data Exclusivity Period from Free Trade Agreement," Auguts 11, 2011
• "Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation," January 9, 2011
• "Snatching Defeat from the Jaws of Victory?" January 17, 2010