Biosimilars Added To FDA’s Citizen Petition Certification Program

Agency estimates it will receive 26 certifications for citizen petitions that could potentially delay biosimilar or generic applications and one certification for a petition for stay of agency action.

FDA is expanding the information it is collecting about citizen petitions to include the certification required to submit petitions challenging the approvability of an ANDA or biosimilar biological product application.

In a Federal Register notice slated for publication on March 11 the agency estimates that each year 26 respondents will submit a certification for a citizen petition under a subsection 505(q) of the Food, Drug, and Cosmetic Act. The subsection prevents FDA from delaying approval of an ANDA, 505(b)(2), or biosimilar application because of a citizen petition unless the agency determines a delay is “necessary to protect the public health.”

FDA issued a final guidance for industry on citizen petitions and petitions for stay of action in June 2011. The guidance provided the agency’s interpretation of the FDA Amendments Act of 2007, which added the 505(q) subsection. The guidance specifies that certification of a petition must include the month, day, and year that the information in the petitions became known to the party on behalf of whom the petition is being filed (Also see "Citizen Petitions Face Strict Certification Requirements Under FDA Final Guidance" - Pink Sheet, 13 Jun, 2011.).

The statute also requires that those submitting supplemental information or comments to citizen petitions and petitions for stay of agency action include a verification and the agency will be collecting that information as well.

In July 2012 the FDA Safety and Innovation Act was signed into law expanding the scope of the subsection to include applications submitted under the abbreviated pathway for approval of biosimilar biologics. FDA said it is now including submissions pertaining to biosimilars in its burden estimates for collecting citizen petition information.

This notice closes the loop on the legislative revisions, allowing FDA to collect the information envisioned in the law.

FDA said it currently has approval from the Office of Management and Budget to collect information on: the format and procedures for submitting a citizen petition; the submission of written comments on a filed citizen petition; the submission of a request to withdraw a citizen petition; the format and procedures for requesting a stay of the effective date of an administrative action; and the submission of written comments on a petition for administrative stay of action.

The agency is now requesting OMB approval to collect:

1. The certification required under section 505(q) for citizen petitions challenging the approvability of a possible ANDA, 505(b)(2) application, or biosimilar biologic application;
2. The certification for petitions for stay of agency action;
3. The verification required for comments to citizen petitions;
4. The verification required for comments to petitions for stay of agency action;
5. The verification required for supplements to citizen petitions;
6. Supplements to petitions for stay of agency action;
7. The verification required for supplements to petitions for stay of agency action; and
8. The petitioner’s letter withdrawing a deficient petition for stay of agency action that is missing the required certification.

FDA published a Federal Register notice in October seeking comments on this collection of information. The agency said no comments were submitted.

In the current notice, FDA includes the estimated annual burden of collecting the information, which comes out to a total of 35 hours. For certification of citizen petitions, it estimates 26 respondents, for which there will be 1.15 responses per respondent for a total of 16 hours. FDA also estimates there will be one certification for a petition for stay of agency action; nine verifications for comments to citizen petitions and seven verifications for supplements to citizen petitions.

Comments on this collection of information are due 30 days from the date of publication in the Federal Register.