Is Your Off-Label Use Now a Federal Crime?

For decades, a "clean mental line" existed: Doctors prescribe, and companies don't promote off-label. That line just got a lot messier. In this episode, Darshan Kulkarni breaks down the Hsaio Declaration—a seismic shift in DOJ enforcement that aims to turn independent medical judgment into evidence of a federal crime.

We dive into the University of Pittsburgh Medical Center (UPMC) subpoena battle, the fallout of Executive Order 14187, and why "Scientific Exchange" may no longer be a safe harbor for Medical Affairs. If you are a physician, a compliance officer, or a pharma marketer, the blast radius of this new theory is larger than you think. Is your prescribing pattern being "engineered" by marketing? The DOJ thinks so.

Transcript

Darshan 0:00

So for decades we've all lived with this clean mental line. Doctors can prescribe off-label, but drug companies cannot promote off-label. But that line just got a lot messier. The Department of Justice, under the new SAW Declaration, is now pushing a theory that off-label prescribing itself by done by a doctor can become evidence of a Food, Drugs, and Cosmetics Act violation when the government thinks that the behavior was shaped, nudged, or engineered by pharmaceutical marketing. So here's what happened. As we know, President Trump issued Executive Order 14187 titled Protecting Children from Chemical and Surgical Mutilation. The Executive Order demanded an end to gender-affirming care. In response, the Attorney General issued a memorandum in April 2025 and it instructed U.S. attorneys to investigate female genital mutilation. The Consumer Protection Branch then began investigating medical providers and the pharmaceutical companies for violations of the Food, Drugs, and Cosmetics Act for engaging in misbranding by making false claims about the on-or-off-label use of puberty blockers, sex hormones, or any other drug used to facilitate a child's so-called gender transition. They sent 20 subpoenas to hospitals and healthcare providers, and they asked for any documents related to this gender-affirming care. They even wanted personal identifying information such as social security numbers, birth dates. And obviously, for many reasons, including the fact that there's many, many privacy issues involved, there was pushback. Parents of patients at the University of Pittsburgh Medical Center, UPMC, moved to quash the subpoena and argued the government is inappropriately using the Food Drugs and Cosmetics Act to criminalize or regulate medical practice. Once a drug is approved, healthcare providers have always been able to prescribe for unapproved uses when medically appropriate. We've seen this in the context of cancer treatments, antibiotics, and many, many other treatment offices. The pharmacists have seen this all the time. The DOJ's position, on the other hand, detailed in a declaration with the acting director, Lisa Sao, signals a significant shift in DOJ policies and around enforcement involving drug treatments. Sao asserts that healthcare providers who prescribe certain drugs off-label may be subject to Food, Drugs, and Cosmetics Act liability. She asserts that providers of gender-affirming care are failing to provide adequate labeling for off-label uses and are actively deceiving patients and parents with false claims and statements regarding the drugs' effectiveness or alternatives and therefore misrepresented risks. We've seen versions of these claims from plaintiffs' attorneys in the past, but never the government, and never under the Food Drugs and Cosmetics Act.

SPEAKER_00 3:01

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Darshan 3:09

So let that sink in. This is not about rogue reps handing out sketchy slides. This is about actual scientific exchange, medical education, and the way influence actually works in real life. So here's the DOJ's angle in plain English. If the company designs messaging, education, or scientific discussions, knowing that they will drive off-label use, the DOJ may argue that the prescribing decision is no longer independent medical judgment. I.e., it becomes the endpoint of an unlawful promotional scheme. That is terrifying. So if you frame it this way, physicians stop looking like a neutral actor and they look like part of that causal chain. And that's new. And it should make prescribers, whether it's your doctor, whether it's your nurse practitioner, whether it's your PA, extremely uncomfortable. For physicians, this is a real risk shift. You're still allowed to prescribe off label. That part hasn't changed. Because again, that's regulated by the state laws. What has changed is that it can now be Monday morning quarterbacking. To see how your decision can be interpreted after the fact. Emails, speaker programs, advisory boards, repeated exposure to educational messages. If the DOJ believes that those interactions were structured to produce off-label use, your prescribing patterns are suddenly evidenced. Look at pharma marketers. This theory blows up that old compliance comfort zone. The one that said, as long as we stay scientific, we're safe. What the DOJ is saying is that intent matters more than labels. If scientific exchange functions like promotion, they will treat it like promotion. And now we're back to intended use. This means that marketers, MSLs, medical affairs, and brand teams are all in that blast radius. Bottom line, off-label prescribing is still legal, but it's not invisible. If you prescribe, ask yourself, who shaped the information you relied on? I'm not even sure you can answer that, but they're asking you to ask that. If you market, assume that the DOJ is reading your strategy deck, not just your disclaimer. This gap between science and promotion just got narrower. And ignoring that reality is how people get subpoenaed. Call, click, or email.