Does Any Party Have Standing to Challenge FDA Drug Approvals?

The very first question during the oral argument in FDA v. Alliance for Hippocratic Medicine, posed by Justice Thomas to Solicitor General Prelogar, was this: "if we agree with you on standing, could you give us an example of who would have standing to challenge . . . these FDA actions?" It was a good question. Already this week, both Professor Segall and I have argued separately that the Court should deny standing to the particular plaintiffs, with my contribution also explaining how the Court might do so. Justice Thomas was implying that under the SG's account of why these plaintiffs lack standing, it's hard to imagine any plaintiff who does have standing.

If that's right, is it a problem? Not necessarily. As the SG would eventually note, the Supreme Court's cases say that the fact that no one has standing to challenge some government action is not a reason to find standing where it is otherwise lacking.

Even so, one might worry that if no one has standing to sue the FDA for improperly approving a drug, the legal structure will be asymmetrical. No one could sue to challenge drug approval, but clearly a disappointed manufacturer whose drug application the FDA disapproves may sue the FDA as an aggrieved party under the Administrative Procedure Act. The manufacturer would have standing because it loses out on the ability to lawfully market its drug. The legal system would be biased towards approval of drugs.

SG Prelogar explained why that would not be a terrible problem for the public: there are other safeguards for the safety and efficacy of FDA-approved drugs and drug protocols. As the Supreme Court explained in Wyeth v. Levine,  in general, FDA approval of a drug, its label, and its approved use does not preclude state law liability suits against the drug's manufacturer. Thus, the tort system provides protection should the FDA goof by approving a drug that is unsafe and/or ineffective. Moreover, and as the SG also noted, FDA revisits prior approvals, protocols, and labels (as it did with mifepristone itself) to keep the regulatory regime up to date.

Those are good answers, but one might think that Justice Thomas's question has some residual force. Ideally, it would be useful if we could point to some party who could, in a timely fashion and without opening the floodgates, have standing to challenge an FDA drug approval. Why? Because one can imagine realistic but extreme cases.

Suppose that the Trump White House had pressured the FDA to approve some new drug to treat COVID-19 despite a dearth of evidence of either safety or efficacy. (I'm putting aside off-label uses of already-approved drugs.) Although tort suits against the makers of such drugs and malpractice actions against prescribers of them could play a role in affecting incentives, we would be better off if such drugs were completely off the (legal) market.

So, can no one ever sue the FDA to challenge a drug approval? Here's what SG Prelogar said in response to Justice Thomas's initial question:

As a general matter, we've seen lawsuits in the past that are brought by, for example, prescribing physicians or patients who want greater access to a drug. Sometimes we've seen theories of competitor standing, where a competing drug manufacturer might sue and claim that FDA's approval of a drug creates a competitive harm or in -- or injury in that sense.

The first suggestion is nonresponsive. Physicians or patients suing for greater access to a drug would not be seeking to void FDA approval but to require the FDA to reconsider its disapproval of a drug.

The competitor standing theory is more promising, although there aren't a whole lot of reported cases. So far as I could discover, the leading one is Schering Corp. v. FDA, a 1995 Third Circuit decision that upheld Article III standing of a competitor and also found that the competitor satisfied the zone-of-interest test for appealing agency action.

However, Schering involved a provision of law governing FDA approval of generic drugs; the statute necessarily had as its target the economic interests of both original brand-name applicants and generic applicants. So the finding that the zone-of-interest test was satisfied would not necessarily carry over to the case of the maker of an established drug suing the FDA to invalidate approval of a new drug made by a competitor. And note the caginess of the SG's statement: she didn't endorse the competitor standing cases; she said merely that "we've seen" such cases.

Maybe more can be made out of Schering, though. The Third Circuit said there that the competitor's interests in contesting the new drug's approval were aligned with the public's interest in ensuring that only drugs that are safe and effective are approved. That will be true in all competitor standing cases.

Here's another scenario in which there could be standing. Suppose that Prescription Drugs R Us (PDRU) is under contract to pay for FDA-approved prescription drugs for a list of illnesses for the hundreds of thousands of employees of a very large employer. Now suppose that the FDA approves a new drug for lowering cholesterol. PDRU's costs would increase dramatically if doctors begin prescribing the new drug because it is still under patent and thus much more expensive than the generic alternatives (such as atorvastatin, the generic version of Lipitor). That's a pocketbook injury that aligns PDRU's interest with that of the public in ensuring that the new drug is actually safe and effective. 

Is PDRU within the necessary zone of interest? I ran that question by an administrative law scholar who thought the answer was yes. I'm not so sure, but the zone-of-interest argument for PDRU is at least as strong as the general zone-of-interest argument for a competitor. And there's certainly Article III injury for both my hypothetical prescription drug insurer and for a competitor. Accordingly, it's at least possible that someone has standing to challenge FDA drug approvals.

What shouldn't be possible is that that someone is the Alliance for Hippocratic Medicine.