Filing Litigation to Challenge FDA Delays in NDA or BLA Review

Though every new presidential administration creates new challenges—and opportunities—for businesses, the second Trump administration has proven to be particularly disruptive for the life sciences industry. Coupled with staffing shortages across the federal government, recent changes at the Food and Drug and Administration (FDA) have created potential uncertainties for pharmaceutical companies seeking to bring new drugs onto the market.

Among the many questions that pharmaceutical companies now face is how to respond to potential delays in the FDA’s review of pending New Drug Applications (NDAs) and Biologics Licensing Applications (BLAs). As courts have held, the Administrative Procedure Act (APA) allows pharmaceutical companies whose NDAs and BLAs have not been timely reviewed to petition federal district courts for relief—and, in particular, for an order compelling the FDA to complete its review of pending applications. 

The APA Authorizes Relief for Agency Inaction 

Under the APA, a plaintiff may bring a lawsuit challenging a federal agency action, including a “failure to act.”[1] As the Supreme Court has recognized, the APA authorizes a court to “‘compel agency action unlawfully withheld or unreasonably delayed.’”[2] And the Court has further explained that an agency “fail[s] to act” when it “fail[s] to take one of the agency actions (including their equivalents)” enumerated in the APA—which includes the issuance of “an agency permit, certificate, approval, registration, charter, membership, statutory exemption or other form of permission.”[3] Thus, as the Supreme Court has discussed, a plaintiff “may obtain judicial review of prolonged agency inaction with respect to its application for a new permit.”[4] 

But, as courts have held, § 706(1) allows compelling only those agency actions that are “legally required.”[5] Consequently, courts will entertain plaintiffs’ claims for relief from delayed agency actions only when plaintiffs “assert[] that an agency failed to take a discrete agency action that it is required to take.”[6] And because § 706(1) “carr[ies] forward” the tradition of writs of mandamus, lower courts have adhered to that writ’s stringent requirement of mandatory action.[7] As the D.C. Circuit has observed, “issuance of the writ [of mandamus] is an extraordinary remedy, reserved only for the most transparent violations of a clear duty to act.”[8] 

Courts accordingly search for clear, mandatory language in statutory and regulatory schemes before finding that they have the authority to compel a delayed agency action. Just last year, for example, the Fourth Circuit stated that “the presence of ‘unmistakably mandatory’ language, such as the word ‘will,’ can provide sufficient evidence of the unequivocal command required for [the court] to hold that an agency is compelled to act.”[9] 

But even when an agency has an obligation to take action, there is no simple, bright-line rule that courts uniformly apply to determine how long of an agency delay will merit judicial intervention. In an influential 1984 decision, Telecommunications Research & Action Center v. F.C.C. (“TRAC”), however, the D.C. Circuit articulated a frequently cited six-factor balancing test to determine “whether the agency’s delay is so egregious as to warrant mandamus.”[10] That test requires consideration of the following points: 

1. the time agencies take to make decisions must be governed by a “rule of reason,”
2. where Congress has provided a timetable or other indication of the speed with which it expects the agency to proceed in the enabling statute, that statutory scheme may supply content for this rule of reason,
3. delays that might be reasonable in the sphere of economic regulation are less tolerable when human health and welfare are at stake,
4. . . . the effect of expediting delayed action on agency activities of a higher or competing priority,
5. . . . the nature and extent of the interests prejudiced by delay, and
6. [that] the court need not “find any impropriety lurking behind agency lassitude in order to hold that agency action is unreasonably delayed.”[11]

In a recent unpublished decision, the D.C. Circuit reminded litigants that a statutory provision that “simply expresses ‘a congressional view that agencies should act within reasonable time frames’” does not authorize relief for delayed agency action under § 706(1).[12] Thankfully for pharmaceutical companies with long-pending NDAs and BLAs, though, Congress has not merely expressed a view that the FDA should act on these applications in a timely matter. Rather, Congress has used the type of mandatory language that can justify § 706(1) relief.

Congress Has Defined Timely Review of NDAs and BLAs 

There is little doubt that the FDA has a mandatory duty to act after it receives an NDA; in fact, Congress has explicitly imposed a 180-day statutory deadline on the FDA. Under the relevant statute, “[w]ithin one hundred and eighty days after the filing of an [NDA], or such additional period as may be agreed upon by the [HHS] Secretary and the applicant,” “the [HHS] Secretary shall either” approve the application or “give the applicant notice of an opportunity for a hearing … on the question whether such application is approvable.”[13] The statute continues: “If the applicant elects to accept the opportunity for hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the [HHS] Secretary and the applicant otherwise agree.”[14] The provisions that govern the FDA’s review of BLAs similarly use mandatory language, but without explicit deadlines:   A BLA that passes safety review and meets other requirements “shall” be approved.[15]

As Judge Nichols of the U.S. District Court for the District of Columbia recently explained in Vanda Pharmaceuticals v. FDA, if the FDA does not approve an NDA within 180 days and instead offers the applicant a hearing, the applicant “has 30 days after it gets notice of an opportunity for a hearing in which to accept; if it does so, the [FDA] has 90 days after that 30-day period has elapsed to begin the hearing.   Adding these steps together … the entire process from application to commencement of hearing should take no longer than 300 days.”[16] Notably, the FDA’s “regulations governing this process . . . institute a different timeline” that deviates from what the statute requires.[17]

Recognizing the importance of the FDA’s timely review of NDAs and BLAs, Congress passed— and has repeatedly reauthorized—the Prescription Drug User Fees Act (PDUFA),[18] which (as part of funding the FDA) requires the HHS Secretary to identify “goals” for ensuring speedy review of drug applications.[19] Through this process, the FDA periodically “agrees to non-statutory performance goals that include deadlines for application review.”[20] The FDA agrees to these “negotiated deadlines”[21] after consulting with various experts, the pharmaceutical industry, and consumer advocates as required by statute.[22]  

The current FDA “goal letter” sets forth such goals “for fiscal years (FYs) 2023-2027.”[23]  These goals include that the FDA will “review and act on” “90 percent of standard NME NDA and original BLA submissions within 10 months of the 60-day filing date” and “90 percent of priority NME NDA and original BLA submissions within 6 months of the 60-day filing date.”[24] These dates are not statutory, but the process by which the FDA must negotiate them is “mandated by Congress.”[25]  And the FDA has stated that it “is committed to meeting the[se] performance goals.”[26]

All of these various timelines—prescribed by statute, by FDA regulations, and by the PDUFA goal letters—are relevant to determining whether the FDA has unreasonably delayed taking action on an NDA or BLA.   

Using the APA to Challenge FDA Inaction

A manufacturer that is frustrated by the FDA’s inaction on an NDA or BLA can potentially leverage the above timelines to bring an APA suit under § 706(1) that seeks to compel the agency to take action on the application.

An important initial question for any such suit would be whether the action is one that the FDA “is required to take.”[27]  Importantly, the Supreme Court has found that “the word ‘shall’ [in a statute] usually connotes a requirement,”[28] and the relevant statutory provisions governing review of NDAs and BLAs use mandatory “shall” language.  Moreover, with respect to NDAs, the D.C. Circuit has stated that the FDA’s review of NDAs satisfies this test—such that the FDA’s “sluggishness” can, under the correct circumstances, be found to have “violated a statutory mandate.”[29] Recently, the FDA even conceded this point in litigation.[30]

And though the FDA has discretion over whether to grant or deny an application, acting on an application is not discretionary.  Thus, the FDA’s failure to act on an NDA or BLA is arguably “specific enough to avoid entangling the judiciary in programmatic oversight, clear enough to avoid substituting judicial judgments for those of the executive branch, and substantial enough to prevent an incursion into internal agency management”—all of which supports the recognition of an APA cause of action.[31]   

Under such a cause of action, the key inquiry would be whether the FDA has “unlawfully withheld or unreasonably delayed”[32] its action on an application such that the court would be justified in granting mandamus relief.[33]  As noted, this is a highly fact-sensitive inquiry often governed by the six-part test laid out in TRAC.  Under that framework, at least one important consideration would be whether the applicant is simply seeking to jump the line in a scenario under which everyone is facing delays.  As the D.C. Circuit once found in a challenge to FDA delays, “a judicial order putting [the plaintiff] at the head of the queue simply moves all others back one space and produces no net gain.”[34] In that circumstance, the D.C. Circuit saw “no basis for reordering agency priorities. The agency is in a unique—and authoritative—position to view its projects as a whole, estimate the prospects for each, and allocate its resources in the optimal way.”[35] 

But in all events, there are many scenarios where the “line-jumping” rationale may not apply—particularly after the FDA has taken initial action on an application.  In Vanda Pharmaceuticals, for example, the FDA had offered the NDA applicant a hearing, which the applicant accepted, but the agency then never actually held the hearing—for which the applicant had been waiting more than 500 days by the time of the court’s ruling. The court consequently ordered the FDA to “resolve [the plaintiff’s] application or commence a hearing [in the next forty days].”[36]   

Much of the court’s analysis in Vanda Pharmaceuticals focused on the widening gap between the statutory—and even regulatory—timeline and FDA’s actual conduct.[37]  And the court emphasized that, although it had “no desire to superintend FDA’s process,” there was “no evidence that [the plaintiff] is attempting to jump a long queue,” further noting its significant doubts over the agency’s claimed inability to meet the applicable deadlines.[38]  The court also noted that PDUFA’s enactment potentially undermined the FDA’s ability to say it lacked sufficient resources to resolve applications on a timely basis.[39]  

The Vanda Pharmaceuticals case presents helpful precedent to consider for applicants frustrated by FDA delays—but the facts of that case were particularly egregious, with the NDA pending for almost 2000 days, and there are not many examples of lawsuits challenging FDA inaction.  Even in less extreme circumstances, though, an APA lawsuit can prove to be a fruitful strategy—as the mere threat of a judgment can sometimes suffice to spark agency action.  In addition, courts frustrated by agency delays can motivate action even without formally granting relief—for example, by requesting regular status updates while keeping the case pending.  Whatever the circumstances, applicants should aim to develop a factual record that will optimize their chances for later arguing that any FDA delays were unreasonable under the flexible, fact-sensitive standards applied to such challenges.