Public Shaming: FDA Edges Closer to Citizen Petition Denial for Intent to Delay Generic Drug Approval, But Prefers to Pass the Buck on Enforcement

By Kurt R. Karst –      

Public shaming has been used as a type of punishment for centuries and has taken on many forms.  In Colonial America, for example, physical forms of shaming and humiliation like stocks and pillory were common.  And who could forget Nathaniel Hawthorne’s The Scarlet Letter, in which a fictional seventeenth century Hester Prynne was forced to wear a scarlet “A” on her chest to show her crime of adultery. 

Public shaming is still used in contemporary America – even in the food and drug space.  For example, back in 2007, the CEO of a medical device company agreed to wear, as part of a plea agreement for marketing an unapproved device, a yellow shirt bearing the inscription “I WAS CONVICTED OF VIOLATING THE FDCA” (see here and here).  Earlier this week, in fact, FDA, as part of changes to the law made by the 2012 FDA Safety and Innovation Act (“FDASIA”), began posting on the Agency’s website redacted correspondence concerning drug and biologic sponsors’ non-compliance with the Pediatric Research Equity Act (see here).  There also seems to be a growing trend in FDA responses to certain citizen petitions alleging misuse of the petitioning process to delay generic drug competition.

By way of background, the FDC Act was amended by the 2007 FDA Amendments Act (“FDAAA”), and again by the 2012 FDASIA, to add Section 505(q), titled “Petitions and Civil Actions Regarding Approval of Certain Applications.”  FDC Act § 505(q) is intended to prevent the citizen petition process from being used to delay approval of pending ANDAs, 505(b)(2) applications and 351(k) biosimilar applications, and says that FDA shall not delay approval of a pending application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. § 10.30 (citizen petition) or § 10.35 (petition for stay of action), unless FDA “determines, upon reviewing the petition, that a delay is necessary to protect the public health.”  FDA must respond to such petitions within 150 days of receipt and report to Congress each year on the Agency’s implementation of the statute.  FDA’s latest report to Congress is available here.  

One provision in Section 505(q) – FDC Act § 505(q)(E) – allows FDA to deny a petition based on intent to delay.  It states:

If the Secretary determines that a petition or a supplement to the petition was submitted with the primary purpose of delaying the approval of an application and the petition does not on its face raise valid scientific or regulatory issues, the Secretary may deny the petition at any point based on such determination.  The Secretary may issue guidance to describe the factors that will be used to determine under this subparagraph whether a petition is submitted with the primary purpose of delaying the approval of an application.

FDA has not yet used this provision to summarily deny a citizen petition.  In guidance (Docket No. FDA-2009-D-0008) and in a proposed rule to implement FDC Act § 505(q), FDA has avoided discussing the provision.  In both documents, FDA merely states that the Agency may issue guidance with respect to the factors it would consider in making such a determination.  Presumably, FDA is hesitant to divine a petitioner’s intent to delay.  Indeed, in a 2009 report to Congress, FDA commented that “[a]lthough a petition may not raise persuasive scientific or regulatory issues when those issues have been reviewed by FDA, a petition can easily raise valid scientific or regulatory issues.”  In that report, FDA acknowledges that the Agency “could issue guidances describing petitions filed under certain circumstances that would give rise to the presumption that a petition was filed with the primary purpose to delay approval” of an application, but says that “given the statutory standard in 505(q)(1)(E) for summary denial of petitions, the agency does not believe issuing a guidance on delay would allow the summary denial of petitions under this provision.  Without any significant impediment to filing a late petition, such as summary denial, it may be difficult to encourage the early submission of petitions under 505(q).”  Moreover, FDA commented that if the Agency “was able to issue a summary denial or brief response to a petition, the agency would still want to have an adequate internal record that the merits of any relevant substantive issues had been addressed in the consideration of affected applications.”

Given FDA’s position with respect to the implementation of FDC Act § 505(q)(E), and presumably in an effort to “encourage the early submission of petitions under 505(q),” the Agency appears to have turned to a different mechanism: public shaming. 

The first instance of a recent citizen petition public shaming that comes to mind is FDA’s April 9, 2012 denial of a 2006 petition (Docket No. FDA-2006-P-0007) – a non-505(q) petition because it was submitted to FDA before the enactment of FDAAA in 2007 – concerning the approval of generic Vancomycin HCl Capsules.  Buried in the 87-page petition response at pages 74-75, FDA comments:

FDA notes that you have petitioned FDA in a fashion analogous to interrogatories in civil discovery, demanding answers to more than 170 individual factual questions related to the Agency's development of the vancomycin bioequivalence recommendation.  This is an improper use of the citizen petition process.  The petition procedure enables parties to “petition the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other fonn of administrative action.”  “Administrative action” is defined in relevant part as “evcry act, including the refusal or failure to act, involved in the administration of any law by the Commissioner.”  The “action” you request the Agency to take here – to respond directly to factual questions regarding certain Agency decisions – is secondary to your underlying challenge of those decisions.  In the interest of a thorough evaluation of the many issues you raise, however, FDA has incorporated these questions and the events referenced therein in its consideration of your petition.

FDA was more bold in a February 2013 denial of a September 2012 505(q) citizen petition (Docket No. FDA-2012-P-1028) concerning the approval of generic Buprenorphine drug products.  In response to comments alleging anticompetitive conduct, FDA said that the Agency would not deny the petition pursuant to FDC Act § 505(q)(E).  Instead, “[t]he Agency has, however, referred this matter to the Federal Trade Commission, which has the administrative tools and the expertise to investigate and address anticompetitive business practices.”

That brings us to the most recent allegations lodged by FDA – the boldest yet that we have seen – against a petitioner.   In an August 2013 denial of a March 2013 petition (Docket No. FDA-2013-P-0247) concerning the approval of generic Zoledronic Acid Injection, in a section titled “III.  Misuse of Petition Process,” FDA comments:

This Petition represents a particularly egregious misuse of the FDA citizen petition process for what appears to be the purpose of delaying generic competition.  Novartis first submitted an incomplete version of this Petition on Thursday, February 28, 2013, and submitted the corrected version on Friday, March 1,2013, just one day before the pediatric exclusivity attaching to the ‘130 patent expired, which would have allowed approval of tentatively approved ANDAs on Monday, March 4,2013.

FDA carefully evaluates assertions that the approval of a drug will put patients at risk, and Novartis’s claims required consultation with experts within the Agency.  That process resulted in some minor changes to the proposed labeling of the generic products, but, as this Petition response demonstrates, the assertions in the Petition were found to be without merit.  We note that the 25-day delay in approval of the AND As was entirely the result of the timing of Novartis’s Petition, rather than its merits.  Had the Petition been filed, for example, even one month before the date on which pediatric exclusivity associated with the ‘130 patent expired, these issues would have been resolved in time for approval of the ANDAs on that date.  Moreover, according to the certification to the Petition, the information on which the Petition was based became known to Novartis on or about November 8, 2011 (Petition at 7).  Had the Petition been submitted within a reasonable time after that date, the Agency could have considered its merits and taken final agency action within the time period contemplated under section 505(q) of the FD&C Act, and resolved the matter before ANDAs were eligible for approval.

FDA’s allegations have drawn a sharp rebuke from Novartis in the form of an August 23rd Request to Supplement the Record and Petition for Reconsideration.  Novartis requests FDA “to strike Section III in its entirety or, in the alternative, to modify any conclusions in Section III based on mistaken inferences resting on prior incomplete information regarding the Petition’s timing.”  According to the petition, “[e]ven if FDA believes that Novartis should have submitted its petition earlier, and wishes to encourage other sponsors to do so, Novartis asks that FDA delete the statements that Novartis ‘misuse[d]’ the petition process, as that and related statements are contrary to the evidence.”

FDA’s decisions not to use FDC Act § 505(q)(E) to deny a petition, but to instead comment on or otherwise allege misuse of the citizen petition process, could be an effort by the Agency to pass the buck on enforcement . . .  and not just to the Federal Trade Commission.  Indeed, FDA’s statements could be used in private litigation to support allegations that companies violated the antitrust laws (see here).