There’s a phenomenon known as off-label prescribing. Basically, to prescribe something off-label is to prescribe it for an indication that is not FDA-approved but that is supported by considerable evidence. For example, it could involve using an FDA-approved drug for an indication that is not within its approval, for an unapproved age range (such as children), or at an unapproved dose or in an unapproved form. Although the FDA has the power to approve drugs for specific indications, it doesn’t actually have the power to regulate the practice of medicine, which means that physicians can use drugs off-label for indications when they think it will benefit the patient and it is completely legal. off-label prescribing is very common and often beneficial. However, there is always the potential for harm as indications for the use of a drug expands beyond its original FDA-approved indication.
The one thing that the FDA has been able to do to regulate the off-label use of drugs is through the Office of Prescription Drug Promotion (OPDP, formerly the Division for Drug Marketing, Advertisement and Communication (DDMAC). In essence, the FDA can regulate drug promotion, and traditionally the FDA has forbidden drug companies from promoting off-label uses of their drugs. Basically, drug companies have been unable to advertise their drugs or promote them to doctors for use off-label, and the FDA has gone after drug companies that have tried to promote off-label uses of their products, particularly through encouraging doctors to use them that way.
Possibly until now:
In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration. The judges said that the ban on so-called off-label marketing violated the representative’s freedom of speech.
The 2-to-1 decision by a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan addresses a long-running and costly issue for the industry, which has paid billions of dollars in penalties to the federal government in recent years after being accused of marketing blockbuster drugs for off-label uses.
In July, for example, the British drug maker GlaxoSmithKline agreed to pay $3 billion in fines, in part for promoting antidepressants and other drugs for unapproved uses; a month later, Johnson & Johnson announced that its pharmaceutical unit had reached a $181 million consumer fraud settlement with 36 states and the District of Columbia over its marketing of Risperdal, an antipsychotic drug.
The case, United States v. Caronia, involved the conviction of a man named Alfred Caronia, who was a sales rep for Orphan Medical. He was selling Xyrem, a drug approved for narcolepsy and was convicted of promoting it as a treatment for conditions such as insomnia, fibromyalgia. Caronia appealed his conviction by arguing that his First Amendment right to free speech was illegally restricted when he was prevented from promoting legal uses for a drug. The ruling only applies to the the Second Circuit (New York, Connecticut, and Vermont), but it’s very possible that the case could find its way to the U.S. Supreme Court.
It’s actually a very interesting legal and philosophical question to ask whether it violates the First Amendment to restrict companies from promoting legal uses of their products. At least, it is as an intellectual exercise. As public policy, it’s a disaster, as the lone dissenting judge points out:
“The government clearly prosecuted Caronia for his words — for his speech,” the majority wrote, concluding later “the government cannot prosecute pharmaceutical manufacturers and their representatives under the F.D.C.A. for speech promoting the lawful, off-label use of an F.D.A.-approved drug.”
The lone dissenting judge, Judge Debra Ann Livingston, vigorously disagreed, arguing that by throwing out Mr. Caronia’s conviction “the majority calls into question the very foundations of our century-old system of drug regulation.” She argued that if drug companies “were allowed to promote F.D.A.-approved drugs for nonapproved uses, they would have little incentive to seek F.D.A. approval for those uses.”
Indeed. I’ve actually pointed out a similar principle with respect to allowing wider access to drugs for cancer patients. If drug companies were permitted to sell, for instance, drugs that had only passed phase I trials, there would be no incentive to do the phase II and III trials to prove efficacy and win FDA approval. In any case, it’s not surprising that pharmaceutical companies are “pleased” with the ruling. Actually, they’re more than pleased with it; they’re practically salivating over the opportunity to market their drugs for indications that go beyond what the FDA has approved. It’s not clear whether this ruling will end up being generalized, but it is clear that it is likely to go to the Supreme Court, as Pharmalot explains. If the Supreme Court sides with the ruling, then it’s possible that drug companies will have more freedom for direct-to-consumer advertising. One thing’s for sure, if this ruling stands you can be very sure that the FDA will be even more constrained than it already is, because it will then have to prove that the statements being used to promote the drug for off-label use are actually false or misleading.
In fact, the problem with this ruling is that it would make it very difficult to know when advertising for off-label uses crosses the line. As long as it’s not illegal for a doctor to prescribe drugs for off-label uses, then it’s much harder to show that promoting off-label prescribing is “false or misleading.” The only way to fix the problem would be to revise the Food and Drug Act to eliminate the loophole, and that itself could have unintended consequences.
There’s also another group besides big pharma that could like this ruling, and like it a lot. Can you guess who it is? Let’s wander on over to the Alliance for Natural Health website, a major trade group for supplement manufacturers, and see the headline Free Speech Court Ruling Could Have Far-reaching Consequences, in which the ANH-USA proclaims:
Big Pharma seems to be the winner. But this could open the door for natural health companies to cite truthful science about supplements.
As we have noted before, the FDA thinks that “misbranding” can mean making a completely true statement about a product but without FDA permission. The FDA is definitely not a fan of free speech.
A cherry producer who cites peer-reviewed scientific research from prestigious universities on the health benefits of cherries would, in FDA-speak, have engaged in “false” and actionable “misbranding” which suddenly turns the cherries into what FDA calls “drugs.” It’s because of this “misbranding” threat that supplement producers are not allowed to discuss scientific research on the efficacy of their products.
The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group representing the drug companies, was of course pleased with the decision. A spokesperson says saying PhRMA “believes that truthful and non-misleading communication between biopharmaceutical companies and healthcare professionals is good for patients, because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments.”
Now remove the word “biopharmaceutical” in the above quote and put “supplement” in its place. The sword that is our freedom of speech cuts both ways!
I can actually see supplement manufacturers also salivating over this ruling. One of the biggest marketing ploys favored by supplement manufacturers. Basically, they cherry pick the literature and find scientific studies, no matter how dubious, to support their use of supplements, and if they can’t find anything they tend to make them up. There is a little fly in the proverbial ointment here, though: The DSHEA of 1994. Supplements don’t have to have FDA approval. On the other hand, even the minimal to nonexistent regulation of dietary supplements that does exist chafes at the supplement manufacturers. That regulation consists of rules saying that they can’t make specific health claims for their supplements, claims that fall under the rubric of drug claims, and can only restrict their claims to relatively vague “structure-function” claims.
How supplement manufacturers would fare if they tried to make the same free speech argument that big pharma has made in a court of law is not known. However, it is very striking just how similar the arguments made by pharma over this case are to free speech argument arguments that supplement manufacturers have been making as they railed against the DSHEA. Or maybe it’s that pharma has learned from supplement manufacturers. At their core, the two industries are much more similar than the “natural” supplement industry would ever care to admit.
57 replies on “Big pharma wins a battle on off-label prescribing”
IANAL but this is the problem when an organization can be exonerated for actions based on an individual employee’s right to free speech. Where is the line drawn that will define illegal speech and will the corporation be held liable for the individual?
Before this goes to the Supreme Court, it will be subject to en banc review by the full Court of Appeals for the Second Circuit. I hope they will overrule it. However, the ruling does seem like a natural extension of the horrendous logic of the Citizens United decision. Be afraid.
As I understand, off-label prescribing is legal, but still experiemental. Therefore, the prescriber has the duty to warn that the Rx is off-label, the drug has not been approved for that use, and the dangers.
based on implied benefits?
FDA rulings are very relevant to those of us outside the US because their rulings are often cited by people pushing woo here and I find that people are more familiar with it than the equivelant organisations in europe so I am very keen to see their powers increased to combat BS. I was under the impression though that supplements if branded correctly dont need FDA approval. Is this true?
Also, I have been reliably informed that big pharma companies often have lots of investments in alt med and supplements but Im at a loss as to how to find evidence of this for myself to use as a reference in debate. Can someone suggest a link to get me started? Or indeed to disprove it if thats the case
Bleugh! My post got cut in half by android! Heres the first half for anyone who is bothered:
Does anyone think they are being intentionally ironic by picking cherries as an example of products that would benefit from cherrypicking?
Im not up on the US legal system (Or the Irish one really) but it seems to me that freedom of speech would be seperate to claims made about a product while promoting it based on implied benefits
Actually, Gary Null appears to know how to USE the rules to make his case: in his own twisted fashion ( and what else would you expect?), he tells audiences that ” Legally, I can’t tell you what ( the supplement) does but you can look it up” and refers you to his own material on particular nutrients or he says, ” I have it labelled ( amount on package) but I TAKE MUCH MORE myself”. Usually he then goes into a spiel about how his bloodwork is always ‘perfect’, how he has no need to sleep more than a couple of hours a night, how he wins running races, how he looks the same as he did 30 years ago AND EVERYONE TELLS HIM THAT and other far-fetched howlers.
Again, the idea that the government might restrict claims plays right into woo-meisters’ courts showing their followers that laws protect the competition- pharma. NOW they might say – “DIdn’t I tell you?” Pharma gets what it wants and we, so pure and natural, have controls dangling over our heads.
OT- but are woo-meisters’ fantasies about governmental suppression ever TRULY OT @ RI?
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Oh, this could be very, very bad for public health. I agree with the dissenting judge. The whole basis for the FDCA was to prevent drug makers from selling and promoting products that had not been proven safe and effective.
I thought, though, that the Free Speech clause does not always apply to commercial speech. Any lawyers that can weigh in?
If a publicly traded pharmaceutical company holds an interest in a supplement company, it should be revealed in their SEC filings.
It’s a tangled history. Under Central Hudson, since 1980, regulation of commercial speech has nominally been subject to an intermediate level of scrutiny. Last year, Sorrell v. IMS Health (decision authored by Kennedy, who also wrote Citizens United) struck down a Vermont law restricting marketers’ access to physicians’ prescribing histories, on the theory that it’s necessary to protect consumers’ access to a free flow of commercial speech. Basically, it appears that now nobody knows what’s going on, since they didn’t actually overrule Central Hudson.
Absolutely NOT happy with this decision. I can see this leading to a ishtstorm of epic proportions if folks are claiming ‘free speech’ while promoting off label uses for drugs.
The only way I can see free speech playing a role in any of this is whether the person is acting as a private individual or acting as a representative of the company, with COI considerations playing a big role in this.
It’s a slippery, difficult line to walk and very easily abused, though. Big ol’ can o’ worms.
Try looking at the First Amendment as a protection for both the speaker and the listener. Kennedy, in Sorrell: “[a]s to the particular consumer’s interest in the free flow of commercial information, that interest may be as keen, if not keener by far, than his interest in the day’s most urgent political debate.” I’m not agreeing with this, but that’s the mentality.
This really worries me because it’s another way to de-fang the FDA and loosen the leash we try to keep on the pharmaceutical companies.
Another aspect is that, IIRC, Burzynski uses a lot of chemo drugs off-label, right? Seems like this would provide him with one more level of immunity.
^ Wait, no, that’s from Virginia State Board of Pharmacy v. Virginia Consumers Citizens Council, from 1976. I think there’s similar language in Sorrell. Hang on.
OK, yah, as manifested in Sorrell:
“Oh, this could be very, very bad for public health. I agree with the dissenting judge. The whole basis for the FDCA was to prevent drug makers from selling and promoting products that had not been proven safe and effective.
I thought, though, that the Free Speech clause does not always apply to commercial speech. Any lawyers that can weigh in?”
I agree. Safety and efficacy of medication rigorously evaluated for one particular use doesn’t guarantee that same safety for another diagnosis. The same standards should also apply to supplements.
Ho…ly…crap. Do my eyes deceive me, or did Jay Gordon, pediatrician to the stars and alt-med shruggie, just say that supplements should be held to the same standards as other drugs? Excuse me while I pick my jaw up off the floor and restart my heart.
Dr. Gordon, I’m glad that you recognize this. Why, then, does your website recommend supplements that have not been subjected to said standards for a variety of conditions, including ADHD and Depression?
Have the safety and efficacy of these supplements been “rigorously evaluated?” I think it may be time to update your website.
Dr. Gordon has personally rigorously evaluated them and found them to be safe and effective. No need for science or clinical trials; his personal clinical experience is infallible.
This *would* at least be self-consistent; the bar for his standard of evidence is buried UNDER the floor, but it’s the same bar to which he subjects autism/vaccine claims.
Very good point. I’ll have to look at that. I think there’s a difference in the wording that might make those statements a little more acceptable . . . but not much. I believe that all of the vitamins and supplements mentioned have been evaluated for general safety but you’re correct in questioning whether they’ve ever been tested for safety or efficacy in treating ADHD.
Sauce for the goose . . .
Oh sweet Jesus . . . that is very disturbing. Only one dissenter? And it’s on free speech grounds? Good grief! This could do more harm than the Citizens United ruling, which also used the First Amendment in a rather tenuous way to achieve something I think is pretty nefarious.
Not all speech is protected. Even if we ignore that the *company* should not be protected based on its *employee’s* free speech rights (otherwise, you can kiss Truth in Advertising laws goodbye), surely this is a “fire in a crowded theater” situation. Death threats are illegal. Lying on your income tax statement is illegal. And companies are not supposed to market products for indications that aren’t approved. Hiding behind the shield of the First Amendment removes most of the *value* of the approval process, as well as the company’s incentive to continue performing studies on the drug. If they don’t have to prove the drug works for X, why would they bother studying it for X?
Put another way, the freedom of speech is not absolute. It can be limited in the face of a compelling public interest. There is a compelling public interest in ensuring drugs are safe and effective.
So what’s to stop tobacco companies from offering cigarettes as a ‘treatment’ for anxiety or executive function disorders? Free speech, man…
Anyone here familiar with the term “Tariel Cell?”
Jay — it’s from “Blake’s 7”. Tarial cells were the technological basis of the fictional computer Orac. I admit I haven’t seen much of that series, but given that it’s from much of the same creative team as “Doctor Who”, it’s gotta be good. 😉
It’s only a three-judge panel.
I wouldn’t necessarily be dismissive. The FDA’s enforcement approach over the years does not seem to have added up to a particularly coherent whole. A situation in which anybody can talk about something except for the class of marketers, on its face, strikes me as iffy. This is where you get scenarios in which a rep giving a presentation is fine saying X in response to an audience question but in trouble for saying the same X otherwise.
Arrgh! I understand why off-label use is permitted for doctors on individual patients, but I really wish it would be limited to clinical trials (that would expand the lable). But clinical trials are very expensive and time consuming, so unless you’re going to get a lot more people taking your drug, it doesn’t make business sense to expand the label. (Hence, doctors perscribing off-label.)
But the sales staff is no where near knowledgeable enough to understand all the implications of off-label drug use, so they sure as hell shouldn’t be promoting it! If, if, if there were a brilliant off-label use for a drug that clearly isn’t ever going to get its clinical trial, then I could see a professional organization sharing information among doctors about it, or even talking to the drug manufacturer about it.
But this sales-force promotion? It’s like a free clinical trial without any controls or ethics.
Self-medicating for ADD with high doses of caffeine, for BPII with various herbs/supplements, for insomnia with melatonin and (yuk) valerian has never been effective, financially or otherwise, for me. The medications I am prescribed work very well, although some tweaks are needed from time to time. My shrink and I stick to generics, as the new brand name stuff has led to some extremely bad results. Fortunately, those trials were brief, and they were samples.
@ Bad poet,
My doctor prescribed me Strattera for my ADD (which is probably caused by PTSD). Work fine so far but it’s really expensive and I glad to have sufficient insurance to cover for it.
Alain: I was on Strattera for a while. I stopped taking it when I graduated from college, as I didn’t want my insurance to notice me. My only caveat is that it seems to have a blood thinning effect; I had copious nosebleeds at the highest dose. Then again, I’m periodically anemic, so your milage may vary.
yeah I have problems with nosebleed but then, I don’t have anemia (checked very frequently by my two doctors) so maybe it’s a side effect of Strattera.
[…] and any health care product or service, and will not only neuter the FDA but the FTC as well. (Orac wrote about this topic yesterday and made the same point. […]
Considering the parallels to the Citizen’s United case, it seems likely that the Supreme Court will support the decision. And as with Citizen’s United, it is hard to envision a Constitutional work-around. There are a few other issues here:
1. Off-label prescribing by physicians is constrained by potential malpractice exposure. It is possible that civil suits against pharmaceutical and “nutriceutical” companies will help to limit abuses.
2. Many medical and educational institutions now have fairly stringent ethical standards regarding interactions of physicians with drug reps. If this stands, it will likely encourage even more restrictive rules.
The Second Circuit did leave open (i.e., managed to sidestep) the question whether such protected speech can be used to demonstrate an intended use, in which case prosecutions based on misbranding could still go forward. (Interestingly, to me at least, the FDCA doesn’t say anything about off-label promotion; this “prohibition” is purely a post hoc construction.)
I’m starting to think, after a day’s reading, that this decision may well be a good thing. Allowing the DOJ to proceed sloppily with such prosecutions later justified with tortured reasoning doesn’t seem much to help anybody.
TL;DR warning. After reading the opinion, I agree with the Second Circuit’s decision, which can be found here: http://www.ca2.uscourts.gov/decisions
First, in response to some of the comments here, this case has absolutely nothing to do with Citizen’s United. The only remote connection this has with Citizen’s United is that the words “First Amendment” appear in the decision and there is a corporation involved (albeit indirectly). This has to do with commercial speech (unlike the political speech funded by a corporation at issue in CU), which is an entirely separate line of cases and judged under an entirely different standard.
Orac’s post is very misleading (to be fair, he depended only on the NYT article). The central holding of the case is that federal law does not prohibit mere off-label promotion of a drug; such off-label promotion is only evidence of the promoter’s intent to misbrand the drug. The government tried to argue that’s exactly what it did, but the court said this argument is belied by the government’s repeated assertions at trial that the speech was criminal conduct in and of itself.
The court only reached the First Amendment issue to justify its interpretation of federal law, because criminalizing such speech, absent any connection to actually mislabeling the drug or any other actually misleading promotion, would raise First Amendment concerns. This is because, under Supreme Court precedent going back decades, content-based regulations of non-misleading commercial speech promoting lawful activity are reviewed under intermediate scrutiny, meaning the regulations must be narrowly-tailored to serve an important government interest, and not burden substantially more speech than necessary.
I agree with the Second Circuit that the outright ban of off-label use speech is unconstitutional. Stating that a drug can be used for a lawful purpose is non-misleading speech promoting a lawful activity, which means it
Oops, my comment was cut off:
…which means it’s presumptively protected by the First Amendment. I agree with Orac that the government has a very important interest in protecting the integrity of the FDA’s approval system, and that keeping an incentive there for drug companies to get approval for a new indication is a concern. But I have a hard time buying that an outright ban from a company/representative of speaking about off-label uses to anyone, ever, is a narrowly-tailored regulation.
I also disagree that this has any impact on advertisements for supplements. The regs Orac posted mentioned that supplements are banned from making specific health claims that make it sound like it has gone through any government approval process. That would fall under the “misleading” exception. This case dealt only with private speech with no connection to actually misbranding a drug. The opinion also said nothing about regulations focused only on the labeling of drugs, and prohibiting off-label promotion on the actual box or even for all public advertisements would be more limited than a blanket ban on all such speech.
Alain: That could be a side effect, yes. I try not to generalize, as my family has a history of weird medical things, and reacting oddly to certain meds is one of those w.m.t.s. I should dig up the bottle sometime and read the list of side effects, since I don’t remember what was specifically listed.
it can also make sense to run trials for an off label indication even if a lot more people won’t be buying your drug if it means you maintain exclusivity longer and keep selling to the people already taking your drug. Getting an existing drug approved for treating a new indication often extends the developer’s exclusivity and delays the introduction of generics. It’s called “evergreening”: maybe you’ll only sell a few tens of thousands of units to treat the new indication B, but if it means you remain the only one who get to sell millions of units to treat original indication A for an extra 5 or 10 years the trials are well worth their cost.
The intersection may be closer than you think (PDF).
@Narad: Oh, I am not saying that there is no reasonable argument that commercial speech should be judged the same as political speech. My only point was that this case has absolutely nothing to do with Citizen’s United, and the Second Circuit’s opinion in no way was dependent on or an extensive of CU. In fact, while the majority conceded that there is some confusion about whether to apply intermediate or strict scrutiny, it explicitly applied the old Central Hudson standard.
I understand what you’re saying, but Caronia indeed saw fit to invoke CU in his supplemental brief, and the Second Circuit itself called for the supplemental briefing in the first place. The decision may not rely on CU, but “absolutely nothing” strikes me as a stretch.
I like the decision. There are plenty of docs who appreciate hearing about off-label uses/studies about pharmaceuticals, as sometimes this knowledge can help difficult-to-treat patients.
I can’t see how a pharma rep could possibly promote a product off-label without being required to make it very clear that the drug is not approved and/or does not have an indication for that use.
A lot of docs are fine with that.
There are also a lot of docs who won’t use a drug outside of its FDA-approved indications. Fine, they won’t be listening to this type of information.
But I don’t see how restricting the flow of information about clinical/biological studies to doctors is in any way in the interest of patients.
@Gingerbaker – Suppose the sales representative refers to uses without much – or any – hard science behind them?
Thats exactly what I was looking for thanks!
Meeting with a staunchly unskeptical friend this weekend and we have agreed to have a discussion on this among other topics, Im not hopeful of any great outcome but at least Il engage with the best facts I can find!
“@Gingerbaker – Suppose the sales representative refers to uses without much – or any – hard science behind them?”
Then the physician, who presumably is not a moron, would pick up on that?
Do you really think a physician would prescribe a drug – completely out of indication – based merely on a passing reference by a sales rep?
I do have to say that in recent years, regulators have been pressing DOWN on off-label prescribing by physicians, perhaps too much. Sure, it’s better to get the formally approved one with strong, judged evidence behind it, but when you have a condition for which there IS no FDA approved treatment, or there’s only one and you’re allergic to it, what then?
@Gingerbaker – I’d love to believe that’s true.
I’ve known quite a few doctors, having grown up in a medical family. And I think I can quite confidently say the answer is “yes”. Doctors are humans; they are vulnerable to all the same biases and foibles as the rest of us, which means all the same marketing tricks work on them, such as giving a huge pile of well-supported information but slipping in some weak stuff too on the fairly well-founded assumption that once folks have accepted the first bits, they’ll take that part along without question.
In fact, although some doctors are famous skeptics, research has shown that the more highly educated a person is, the more likely they are to fall for a scam or believe something which is only weakly supported by evidence. It’s because lots of education makes it very easy to fall into the trap of thinking you’re smarter than other people, too smart to fall for a scam. But more education doesn’t actually make you smarter (just better informed) and it doesn’t make you too smart to be scammed. And of course doctors have a lot of education.
Doctors have another thing going against them in this area — they went into the profession because they want to help people be well. We all know what the road to hell is paved with, though. Wanting very much to help someone might make one a little better disposed towards trying more radical things or even lead one into wishful thinking about a possible treatment for a patient.
So yes, I do think a physician would prescribe a drug off-label based on something a sales rep said in passing. How often does it happen? Very hard to say, but given that the sales tactic works fine in other contexts, I see no reason to think it wouldn’t work in this context.
Oh, and one other thing:
But this decision basically says that the rep does not have to make it clear the drug is not approved and is not indicated for that use, unless I’m badly misunderstanding it. In any case, I’m a bit wary of that sort of language, because it could open the way to a fig-leaf bit of language that would be the pharma equivalent of the “quack miranda” (“this product is not intended to treat disease, yaddayadda”, right after claims that it can treat disease). I do think it’s important to allow the free flow of information about the state of scientific knowledge, but I tend to think that marketroids from pharmaceutical companies are about the last people I’d trust to actually do so in a fair and open way. It’s a difficult balance to strike there, but perhaps if they make their communications in the venue of scientific publication rather than speeches given at free dinners?
So it’s okay if I recommend Thalidomide as a morning sickness preventative despite the fact it’s only been approved for use as a sleeping pill?
Now the big question is, would Charles Nemeroff MD/PhD and any peoples of its kind are no longer useful for big pharma?
Is it likely that insomnia can also be treated by the same thing that treats narcolepsy?
Also… wow, meeting of RI and Popehat; the latter recently commented on banning conversion therapy, and here we have discussions of 1st Amendment issues. Weird.
Interestingly, over there, there’s a tendency to assume that buyer-beware is better than regulation. This is how ‘freedom of speech’ can so easily influence issues like this.
You should see what they do with the ‘fire in a theatre’ bit over at Popehat. Yet another shade of grey in this whole mess.
Orac says “There’s a phenomenon known as off-label prescribing. Basically, to prescribe something off-label is to prescribe it for an indication that is not FDA-approved but that is supported by considerable evidence.”
Let me correct that a little: There’s a phenomenon known as off-label prescribing. Basically, to prescribe something off-label is to prescribe it for an indication that is not FDA-approved.”
Actually, I’m sure Orac meant what he said, and that physicians like him prescribe for non-approved indications when they have substantial evidence to support their decision, but …
For example, doctors prescribe HCG for weight loss. Not merely not approved but, according to the FDA, not supported by evidence at all. See http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm281834.htm
‘5. Are prescription HCG products safe and effective for weight loss?
No. FDA-approved uses for prescription HCG products include female fertility and select hormonal treatment in males, and FDA has not approved prescription HCG for any other uses, including weight loss. Current scientific evidence does not support the claim that HCG is safe and effective for weight loss or for the treatment of obesity. In fact, FDA labeling for the approved HCG drug products requires the following statement about the use of HCG for weight loss:
“HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.”’
Now I’m all on favor of off-label uses – I’m an orphan disease sufferer, so all my treatments are off-label: no drug company bothers to conduct studies in my condition. Which is not to say that it isn’t studied – it is, but not in a way likely to lead to FDA approval for the condition; and believe me I’m grateful for that research. But surely there is an appropriate middle ground between “you cannot say anything except about the approved indications” and “you can’t be penalized no matter what nonsense you spout to sell your drug”.
Kiwi wrote, “Actually, I’m sure Orac meant what he said, and that physicians like him prescribe for non-approved indications when they have substantial evidence to support their decision, but …”
I strongly doubt most physicians have strong evidence to support off-label uses. The evidence in support of a lot of _on_-label uses isn’t necessarily all that strong.
It’s stating that you can’t slap a criminal penalty on someone for truthful and nonmisleading speech. That’s pretty much it.
Yeah, Narad is right. There’s nothing in the decision that says reps cannot be forced to disclose that the drug is not approved for a particular indication. In fact, making that a strict requirement, perhaps on top of other disclosures, is another type of less-restrictive regulation that would probably be upheld. The only thing decided was that you can’t make it a criminal offense for merely mentioning an off-label use.