WASHINGTON — Supreme Court Justice Samuel Alito had a clear question at Tuesday’s arguments over the abortion pill mifepristone: If the doctors who brought that case can’t sue the FDA over a drug’s label, who can? And when?
“Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful? And maybe what they did was perfectly lawful, but shouldn’t somebody be able to challenge that in court?” Alito asked the government’s lawyer.
While it’s not impossible to sue the FDA to restrict a drug’s label, or its prescribing rules, the circumstances are slim, experts told STAT Wednesday. To establish standing to challenge the FDA, plaintiffs would have to show not only that the agency’s drug approval directly harmed them, but that the harm would be addressed with its withdrawal or an updated label. For someone already injured by the product, an FDA change would not address those issues — which is why, when patients are looking for compensation for injury, they often sue the drugmaker or provider instead.
“FDA is covered in the fact that they’re issuing an instruction manual, a label, saying this is how you should use it, and these are the risks,” said Mikkael Sekeres, hematology chief at the University of Miami’s Sylvester Cancer Center.
But at least one person has tried to take the FDA to court to force the agency to narrow the use of a drug before.
Longtime pharmaceutical manufacturer Ed Thompson sued the FDA in 2017, arguing its approval Roxybond, an opioid its manufacturer said is abuse-deterrent, has no evidence for the claim or prescription for chronic use. Thompson argued that as an opioid manufacturer himself — first at Johnson & Johnson in the 1970s, and later at his own Pennsylvania plant, Pharmaceutical Manufacturing Research Services — no opioid should be authorized for chronic pain and long-term prescription.
“For sure I have standing,” he told STAT. “There’s no adequate and well-controlled studies to show abuse deterrence, there’s no adequate and well-controlled studies to show chronic treatment.”
A Pennsylvania district court disagreed, and the case was thrown out.
Thompson, realizing he was never going to establish standing under current law, tried a new tack: He manufactured a generic oxycodone in his plant and submitted it for FDA approval, with the explicit note that it would not be authorized for chronic pain. If the FDA greenlit his version, it would essentially force the same labeling onto existing, identical forms of oxycodone, he said.
But the agency did not approve his application, and Thompson took them to court again. This time, a D.C. appeals court judge threw the case out on a technicality.
Thompson was not the first to mull suing the FDA over a too-broad label, even as a mountain of other lawsuits focused on opioid manufacturers and distributors. Andrew Kolodny, a Brandeis University opioid policy researcher and founder of activist group Physicians for Responsible Opioid Prescribing, told STAT that the organization considered this route as well, amid mounting frustration with the agency’s opioid crisis response.
But after speaking to some of the most prominent advocates for drug and device safety, such as Sidney Wolfe, founding director of Public Citizen’s health division, PROP did not pursue a lawsuit.
“What I heard from Sid, and what I heard from others, was that it’s very hard to sue the FDA,” Kolodny said.
Over many years at Public Citizen, Wolfe spearheaded at least 28 successful efforts to limit or pull certain FDA-approved products from market, typically by unleashing a series of petitions, advisory committee appearances, and public campaigns.
“Generally, the process for challenging an FDA approval is not via a lawsuit, but via a citizen petition,” Allison Zieve, director of Public Citizen’s litigation group, wrote to STAT in an email. The FDA is required to respond to every petition, even if that means denying them — or saying it cannot respond within the given window, which Thompson said was the response to multiple opioid petitions he filed.
“Because the FDA is not infallible, the limits on standing can be frustrating,” said Zieve, referring to the right to sue. “That showing standing is difficult, however, does not mean that it is never possible. I think, for example, that a hospital might have standing if it could attest to having so many patients arrive in the emergency department experiencing harm from a particular drug that it was unable to keep up, resulting in delayed treatment of other patients or forcing it to spend money to hire more doctors and nurses.”
As reported Tuesday, the Biden administration is arguing that plaintiffs in the mifepristone case did not “come within a hundred miles” of proving that happened, or could happen, to emergency room doctors because of increased abortion pill access.
Instead, the vast majority of lawsuits against FDA decisions represent the reverse of mifepristone’s plight: Drugmakers contesting restrictions on their medicines, or patients and states suing for broader use or earlier access to restricted or experimental drugs. Battles like the latter particularly rose after several states, and later Congress, passed “Right to Try” legislation that opened the channels for patients to directly appeal for unapproved medicines.
“There’s always this tension about the FDA; [The agency] is accused of working too fast and too slow all the time,” said Sekeres, who wrote a history of the agency’s evolving regulatory process, “Drugs and the FDA,” that delved into times the agency ordered a product off the market or curbed its use.
Courts have generally ruled against patients suing for experimental therapy access outside of clinical trials. But pharmaceutical companies have had slightly better luck challenging the agency’s decisions. One small biotech, Amarin, in 2016 won a dispute that freed the company to communicate with doctors about its fish oil-derived heart pill, Vascepa.
That companies have more success suing the regulatory agency is not necessarily surprising, but presents an uncomfortable reality, especially for anti-opioid advocates such as Kolodny.
“I realize that powerful corporations … have the ability to sue regulatory agencies in ways that can be harmful to the public, and that concerns me,” he said. “But I believe that federal agencies should be required to comply with federal law … And sometimes you need the law to compel a federal agency to regulate forcefully.”
Asked if he would sue the FDA again if the Supreme Court upheld mifepristone restrictions, Thompson said he was not sure.
“I don’t do things trivially,” he said. “You really have to think that you’re doing the right thing and have some hard ground to do it.”