New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

On May 2nd, the U.S. Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review.  That bill is S. 1067, the “Ensuring Timely Access to Generics Act of 2023,” and it would fundamentally transform the playing field for NDA, ANDA, BLA, and aBLA applicants seeking to preserve their rights in the wake of an adverse FDA approval decision.

It does so by amending FDC Act § 505(q), the current statutory subsection regarding citizen petitions.  Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. L. No. 110-85 (2007), as amended by Section 301 of Pub. L. No. 110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub. L. No. 112-144 (2012).  And, as originally drafted, it was narrowly intended to prevent the citizen petition process from being used to delay the approval of ANDAs,  505(b)(2) applications, and aBLAs.  We’ve posted on FDC Act 505(q) many times over the years (see, e.g., here, here, here, and here).

As background, FDC Act § 505(q) states that FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar 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 is required to “take final agency action on a petition not later than 150 days after the date on which the petition is submitted.”  FDA may not extend the 150-day period “for any reason,” including consent of the petitioner.  In addition, FDA may deny a petition if the Agency “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.”

That last provision—concerning petitions that are intended solely to delay the entry of competing products—was the subject of FDA’s most recent modifications to guidance on FDC Act § 505(q) (see our previous post here), in which FDA identified the various factors it would apply in determining whether or not a petition was submitted to the Agency with with the primary purpose of delay.  And in December 2021, we saw FDA apply those factors in responding to a citizen petition (Docket No. FDA-2021-P-1211) concerning generic VASOSTRICT (vasopressin).

Current FDC Act § 505(q) also includes a provision addressing judicial review of final Agency action.  Specifically, subsection 505(q)(2) deems FDA to have taken judicially reviewable final agency action on a petition if the Agency either makes a final decision within the meaning of 21 C.F.R. § 10.45(d) during the 150-day period (including the common FDA response of denying a petition without comment), or if the 150-day period expires without FDA having made a final decision on the petition.  Under current FDC Act § 505(q)(2)(B), if a civil action is filed against FDA “with respect to any issue raised in the petition before the Secretary has taken final agency action on the petition. . . , the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.”  This statutory provision was tested once without much luck (see our previous post here).

With that background, let’s get back to S. 1067, which first reared its head in Spring 2022 as an amendment to  S.4348, the “Food and Drug Administration Safety and Landmark Advancements Act of 2022” (Section 511).  In addition to amending FDC Act § 505(q) to incorporate the various “intent to delay” factors FDA currently uses to determine whether a petition was submitted with the primary purpose of delaying FDA’s approval of an application, the new bill rewrites FDC Act § 505(q)(2) in a manner that appears calculated to immunize FDA’s actual final approval decisions from timely judicial review.  Specifically, the bill would amend the law to state:

(2) Exhaustion of administrative remedies

(A) IN GENERAL.—A person shall submit a petition to the Secretary under paragraph (1) before filing a civil action in which the person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act. Such petition and any supplement to such a petition shall describe all information and arguments that form the basis of the relief requested in any civil action described in the previous sentence.

(B) TIMELY SUBMISSION OF CITIZEN PETITION.—A petition and any supplement to a petition shall be submitted within 60 days after the person knew, or reasonably should have known, the information that forms the basis of the request made in the petition or supplement.

(C) FINAL AGENCY ACTION.—The Secretary shall be considered to have taken final agency action on a petition if—

(i) the Secretary makes a final decision within the meaning of section 10.45(d) of title 21, Code of Federal Regulations (or any successor regulation); or

(ii) on or after the date that is 151 days after the date of submission of the petition, the Secretary approves or has approved the application that is the subject of the petition without having made such a final decision.

(D) DISMISSAL OF CERTAIN CIVIL ACTIONS.—

(i) PETITION.—If a person files a civil action against the Secretary in which a person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act without complying with the requirements of subparagraph (A), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.

(ii) TIMELINESS.—If a person files a civil action against the Secretary in which a person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act without complying with the requirements of subparagraph (B), the court shall dismiss with prejudice the action for failure to timely file a petition.

(iii) FINAL RESPONSE.—If a civil action is filed against the Secretary with respect to any issue raised in a petition timely filed under paragraph (1) in which the petitioner requests that the Secretary take any form of action that could, if taken, set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act before the Secretary has taken final agency action on the petition within the meaning of subparagraph (C), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.

Yeah, you read that correctly!  If S. 1067 is enacted, it would require potential litigants to submit a citizen petition to FDA not only before filing suit with respect to issues that were known and could have been raised prior to FDA’s approval of an application, but also before filing suit with respect to previously unknown issues even after FDA has granted a final approval—the quintessential “final agency action” in the FDA context, and of course the subject of hard-fought Administrative Procedure Act litigation in the federal courts for decades.  Taken together, these aspects of the proposed legislation are likely to prevent potential litigants—including brands, generics, public-interest groups, and interested members of the public—from vindicating their rights or protecting their interests in multiple contexts, and ultimately poses a clear and direct threat to the public health by immunizing critical safety-related issues from timely judicial review.

These problems arise because sponsors and other interested members of the public frequently do not know about potential regulatory issues (or cannot reasonably disclose what they may know about those issues because of a protective order in pending litigation or other trade-secret and confidentiality concerns) until after FDA issues a final approval.  Indeed, in many cases, no one beyond FDA and the application’s sponsor has any idea that an application implicating such issues even is pending before the Agency; FDA’s confidentiality regulations preclude the Agency from disclosing the existence of an unapproved application, and sponsors who otherwise might receive notice of a pending application (e.g., by receiving a Paragraph IV notice) nonetheless might remain in the dark because a particular application references a different RLD or lacks a Paragraph IV certification.

S. 1067, however, could effectively preclude potential litigants from protecting their interests in court even if they had no idea about a potential issue prior to approval, even after FDA has fundamentally altered the marketplace by approving an application in alleged violation of the law—for instance, by issuing approval before the conclusion of a thirty-month stay; a pediatric exclusivity period; a new chemical entity (“NCE”) or new-indication exclusivity period; an orphan-drug exclusivity (“ODE”) period; a 180-day exclusivity period; or by approving disputed labeling change. That is so because the proposed bill would condition access to the courts on: (1) potential litigants first filing a post-approval citizen petition asking FDA to unwind its approval decision; and (2) the Agency then taking final action on the post-approval citizen petition, which the statute makes clear can up to 150 days.

Between the time needed to prepare such a post-approval citizen petition; and the 150-day period FDA is granted to address such a petition; and the time it takes to prepare post-petition litigation papers; and the time it takes a court to resolve litigation after it is filed, S. 1067 easily could prevent the sponsor from securing judicial relief for 6-9 months after an allegedly unlawful approval.  That delay would consume the entirety of an NDA holder’s pediatric exclusivity or a first-to-file ANDA sponsor’s 180-day exclusivity, and a considerable portion (if not the entire remaining amount) of a thirty-month stay, new-indication exclusivity, NCE, or ODE period.  Importantly, because FDA has sovereign immunity from damages claims, sponsors trapped in S. 1067’s post-approval citizen petition web can never be made whole for their losses even if a court later agrees that FDA acted unlawfully in approving the application at issue.

S. 1067 isn’t bad just for application sponsors. It threatens grave risks to the public health. While these two authors certainly have seen our fair share of petitions and lawsuits raising dubious “safety concerns,” and indeed have persuaded FDA to refer bad actors to the FTC in past cases, we also have been party to a number of matters that raise indisputably serious potential health risks.  We have the utmost respect for the seriousness with which FDA’s scientists and regulatory professionals approach these matters, and are confident that no one at FDA wants to see potentially dangerous drugs on the market.  But FDA also tends to move slowly and deliberately even under the best circumstances; it is chronically underfunded, overwhelmed by competing demands (including a backlog of unresolved citizen petitions), and—like all federal agencies—constrained in its ability to respond even to the most pressing matters because of the cumbersome bureaucratic procedures inherent in any administrative agency (especially one as sprawling as FDA).

In the many decades we have been practicing in this space, we are fortunate that FDA has never once refused to engage when we’ve brought an urgent matter to its attention.  But it’s one thing to discuss matters with the Agency, and another thing entirely for FDA to take action.  Litigation risk tilts the balance: In our experience, the prospect of taking FDA to court when it makes a mistake, violates the law, or otherwise compromises the public interest is the only tool that reliably ensures FDA will prioritize a given issue and dedicate the resources and personnel needed to resolve it quickly and appropriately.  Put simply, nothing focuses FDA’s attention on a matter more effectively than the risk it might soon be forced to explain its action (or lack of action) to a United States District Judge. We have no doubt the same is true of other federal agencies—which, of course, is a big reason why the Administrative Procedure Act has authorized aggrieved parties to file suit over an agency’s undue delay or its final agency actions for nearly 80 years.

S. 1067 would gut that venerable tool: By curtailing timely judicial review of final approvals—game-changing final agency actions that, to reiterate, have been litigated for generations—the proposed law threatens to remove the only real leverage through which the public can ensure prompt agency action. And without that tool, there is literally nothing to prevent FDA from taking months to evaluate market-transforming legal issues and pressing safety concerns, even as vulnerable patients are exposed potentially dangerous drugs and sponsors see their competitive standing destroyed. Indeed, that appears to be the precise objective of these provisions in S. 1067: to make it more difficult for the public to hold FDA to account after it has approved a product in alleged violation of the law, by shielding FDA from litigation.  The fact that S. 1067 might allow these issues to be litigated months down the road therefore provides no solace: That’s far too late for patients, sponsors, and the broader public.

We certainly hope that Senate HELP will consider these issues as it entertains S. 1067 later this week in its Executive Session, and encourage readers of this blog to consider contacting your Representative and Senators about S. 1067 at the earliest possible opportunity.