FDARA: Senate Takes Action on Citizen Petition Abuse & Requires Disclosure of Interests

June 7, 2007

There is a wise political maxim, “Fool me once, shame on you; fool me twice, shame on me.”  Not to be fooled a second time, the U.S. Senate has passed legislation that would, if enacted, make significant changes in the way FDA handles so-called “generic blocking” citizen petitions.  The measure is part of the FDA Revitalization Act (“FDARA”) passed by the U.S. Senate in May 2007.

Fool me once . . . .

In November 1999, FDA issued a proposed rule to revise the Agency’s citizen petition regulations at 21 C.F.R. § 10.30.  At that time, FDA stated that “[q]uestions have [] arisen whether a citizen petition can be used for improper purposes, such as delaying competition . . . or delaying agency action,” and noted that there was a citizen petition backlog.  As such, FDA proposed several options intended to reduce the backlog, to facilitate and improve FDA interactions with petitioners, and to avoid frivolous petitions, including limiting petitions to “request that the agency: (1) Issue, amend, or revoke a regulation; (2) amend or revoke an order that the agency has issued or published; or (3) take an action as specifically authorized by another FDA regulation.”

In April 2003, FDA withdrew the proposed rule.  In taking this action, FDA stated:

As we evaluated the comments [submitted in response to the proposed rule, such as the Federal Trade Commission’s [http://www.ftc.gov/be/v000005.pdf]], we continued efforts to improve our handling of citizen petitions.  These efforts have led to a marked increase in the number of citizen petition responses, and our current annual response rate is equal to, and sometimes even exceeds, the number of citizen petitions that we receive.  Given this progress, we believe that a revision of the citizen petition regulations is not warranted at this time. 

FDA’s withdrawal notice, however, did not address the lingering concern raised in the proposed rule about “generic blocking” petitions.  Indeed, a few years later, in 2005, FDA continued to express concern:

The citizen petition process is in some cases being abused.  Sometimes, stakeholders try to use this mechanism to unnecessarily delay approval of a competitor’s products. … [we’ve] already seen several examples of citizen petitions that appear designed not to raise timely concerns with respect to the legality or scientific soundness of approving a drug application, but rather to delay approval by compelling the agency to take the time consider arguments raised in the petition, whatever their merits, and regardless of whether the petitioner could have made those very arguments months and months before.

Fool me twice? . . .  Not a Chance . . .

Recognizing that an overhaul of the citizen petition process would be necessary to prevent the type of abuse about which FDA expressed concern, and that the Agency would likely be unable to carry through to completion the type of proposal made in November 1999, a cadre of Senators, led by Sen. Debbie Stabenow (D-MI), spearheaded an initiative to include a provision in FDARA to require swift FDA action in response to citizen petitions with the ability to stall or block generic competition.

Specifically, FDARA § 506 (which is similar to a provision in Sen. Stabenow’s “Lower PRICED Drug Act” introduced earlier this year) would amend the FDC Act to add § 505(s) – “Citizen Petitions and Petitions for Stay of Agency Action.”  Under new (if enacted) FDC Act § 505(s):

[T]he receipt and consideration of a petition [(including a citizen petition, petition for stay of action, or other request) to delay consideration or approval of an ANDA or a 505(b)(2) application] shall not delay [such] consideration or approval . . . unless [FDA] determines, not later than 25 business days after the submission of the petition, that a delay is necessary to protect the public health. . . .  Notwithstanding [such] a determination . . . [FDA] shall take final agency action with respect to a petition not later than 180 days of submission of that petition unless [FDA] determines, prior to the date that is 180 days after the date of submission of the petition, that a delay is necessary to protect the public health.

In cases where FDA determines that a delay is necessary to protect the public health, FDARA § 506 would require FDA to promptly provide a detailed and publicly available statement with the reasons underlying the Agency’s determination, and to provide the affected generic applicant with an opportunity to meet with appropriate FDA staff to discuss the Agency’s determination. 

In addition, FDARA § 506 would require persons submitting petitions and comments to make certain written verifications, including the following: “I received or expect to receive payments, including cash and other forms of consideration, from the following persons or organizations to file this petition [(or for commenters – to submit this information or its contents): _______.”  Thus, while today companies can submit petitions and comments anonymously via, for example, a law firm, if the Senate-passed version of FDARA § 506 is enacted, it will be more difficult for companies to cloak their activities and interests.   

Categories: Hatch-Waxman