Rep. Eshoo Expresses Views on Abbott's Biosimilars Petition in Letter to FDA

by McDonnell Boehnen Hulbert & Berghoff LLP

[author: Donald Zuhn]

FDAWhile 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 AAbbott 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).

Eshoo, AnnaIn 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


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.