Earlier this year, the US Supreme Court struck down a highly controversial Vermont law that restricted the sale of prescription drug info identifying prescribers and patients for commercial marketing purposes. The practice is known as data mining and has been growing for the past two decades, ever since data was gathered by market research firms (back story). However, the implications are reverberating as the pharmaceutical industry is using this ruling to argue in other cases that off-label promotion is a form of protected speech (see this). We spoke with Tamara Piety, a professor at the University of Tulsa College of Law who specializes in commercial and corporate speech, about where all this is headed…

Pharmalot: Before the Supreme Court ruling, the issue was largely thought of as data mining. How did we get from there to thinking of this in terms of a ban on off-label promotion?
Piety: Well, the Sorrell case was treated as a commercial speech case. The Vermont statute provided that this data about physicians’ prescription practices could not be sold to be used for marketing purposes. It did not ban sales of the data to be used for other purposes, just marketing. Promotion is basically marketing in the hands of the seller. For example, a physician who thinks that a particular drug is effective for treating some condition for which the drug is not approved can write an article setting out her opinion that this drug is very effective for treating such and such condition and it could be said that this article promotes the off-label use, but when the company that manufactures the drug urges doctors to prescribe that drug for that same condition, that’s marketing and it is, as I understand it, prohibited by the FDA regulations. The thrust of this prohibition is, presumably, that we don’t want the manufacturer, which obviously has a financial interest in selling as much of the drug as it possibly can, to tout the drug’s efficacy for treating conditions for which the FDA has not assessed its use.

Since the Court struck down the statute in Sorrell as contrary to the First Amendment, we can expect that language to be used by those who argue that a ban on off-label promotion that applies solely to the drug companies is discriminatory and similarly violates the First Amendment. By the way, this development is the flowering of approximately 40 years of strategic litigation and intensive lobbying to get full First Amendment protection for commercial speech. Prior to 1976 and the creation of the commercial speech doctrine, no one thought advertising and marketing efforts like these were even covered by the First Amendment, so there are any number of statutes, not only related to drug marketing, but many, many other products and services, that are likely to be attacked as unconstitutional. Many of these laws are one that I think most people think are good laws.

Pharmalot: How did the Sorrell v. IMS case fit into this?
Piety: In Sorrell the data mining and pharmaceutical companies argued that Vermont’s singling out of marketing for different treatment than say, research or law enforcement was discriminatory. The Sorrell opinion used the word disfavored a lot. It cast the data miners and drug companies in the role of a disfavored speaker with a viewpoint the government didn’t like. What the opinion does is leverage the language of civil rights and political speech to suggest that somehow the regulation of marketing is discriminatory. But this is nonsense because the commercial speech doctrine itself, as established, treated marketing differently than other speech that the First Amendment protects. As I say, for years industry has been trying to get rid of the commercial speech doctrine and to get a ruling from the Court that commercial speech ought to have the same level of protection as political and expressive speech. And with Sorrell they have largely gotten what they wanted because the Sorrell opinion barely mentions the Central Hudson test.

Pharmalot: What do you mean by the Central Hudson test?
Piety: Central Hudson is a Supreme Court opinion from 1980 that sets out the test which governmental regulation of commercial speech must pass in order to be consistent with the First Amendment. The decision which created the commercial speech doctrine in 1976, Virginia Pharmacy, set up this intermediate level of protection for truthful commercial speech. It said that commercial speech that is truthful (false commercial speech got no protection) is protected by the First Amendment, and so if the government wants to regulate this truthful commercial speech, it has got to show it has a good reason for doing so and that its regulation addresses the problem. But the opinion didn’t clearly articulate when governmental regulation would be constitutional and when it wouldn’t and so 4 years later, in Central Hudson, the court created this four-pronged test that is supposedly still the governing test today.

It provides that in order for a regulation of commercial speech to be constitutional the following criteria have to be met: The first question is whether speech, assuming it is speech, that the statute is intended to regulate is speech that involves a legal activity, and is not misleading. If the speech in question involves a legal activity and the speech is truthful then you go to the next three prongs. The second prong says the government has to have a substantial interest that it is trying to address with the statute. In Sorrell, for example, Vermont said that prescriptions of brand name drugs over generics drove up health care costs for the state. Moreover, some doctors lobbied the Vermont legislature claiming that the practice of selling their prescription information so it could be used to pitch drugs to them violated their privacy. So the state had an interest in responding to those complaints. Under the third prong a statute must directly advance the government’s substantial interests. Here that means that the statute must actually do something to lower health care costs and protect doctor privacy. And prong four of Central Hudson requires that the regulation not be broader than necessary to serve that substantial government interest. In other words, it can’t suppress a bunch of speech which is not the target speech or which wouldn’t have any impact on lowering health care costs or protecting doctor privacy. The Sorrell Court sort of went through all of these issues, but more as an afterthought than as the decisive factor.

Pharmalot: So let’s circle back. Put this in context.
Piety: Well, instead of the court saying, “This is a commercial speech case and so we must apply the Central Hudson test,” which would have been the conventional way to approach it if you think this is a commercial speech case, for the first 16 pages of the opinion, the court talks about content neutrality and whether the statute singles out marketing as a disfavored activity and concludes that this is constitutionally impermissible. So the court doesn’t explicitly overrule Central Hudson, but it seems like it treats Central Hudson it as if it’s fairly irrelevant. And again, I think that is nonsensical because by definition, the commercial speech doctrine singles out marketing for different treatment because it’s marketing. For most of our history, we have thought it appropriate to regulate marketing and to treat commercial speech differently than expressive or political speech. This ruling suggests it’s not appropriate to make that distinction.

Pharmalot: How does this get us to the point where off-label marketing may be protected?
Piety: Off-label marketing is, in one view, marketing and if it isn’t appropriate to single out marketing for different treatment how can you justify all the rest of those prongs in the Central Hudson test? It seems like Sorrell offers an argument that this off label marketing regulation singles out particular speakers and disfavored points of view for suppression and that that is not constitutional. Now that is what the drug companies will argue. In my view this is a misuse of notions of content neutrality and antidiscrimination. I think it is perfectly appropriate to treat commercial activity, and commercial speakers, differently than you would the doctors, journalists, government officials and members of the public. Moreover, there is an argument, assuming that Central Hudson still applies - which, since the court didn’t overrule it is theoretically the case - that promoting off-label use of drugs approved for different purposes is not a legal activity and, thus, does not meet the first prong of Central Hudson any more than it would be legal for the seller of an illegal drug to promote it, even though we would offer full First Amendment protection to someone advocating for the legalization of illegal drugs.

Moreover, you might have an argument about whether such promotion is truthful. If you are simply reporting that such and such a trial was done, or some doctor wrote such and such article, arguably conveying that information to a doctor is truthful. But if you reframe the marketing as an attempt to convey that the use of this drug for a purpose other than for what it was approved is safe, or effective or what have you, there is an argument that this is misleading and further fails prong one of Central Hudson.

Pharmalot: So what might this mean?
Piety: Other courts are liable to use Sorrell to say that regulating marketing in almost any fashion is unconstitutional and so, as I say, the implications are much broader than just off-label marketing. The ramifications of this ‘anti-discrimination against marketing’ argument go well beyond the off-label marketing of prescription drugs. This same argument is currently being used to attack the new FDA regulations regarding cigarette packaging, securities regulations, junk food marketing and many others. It is hard to say what the stopping point may be because, on the one hand, it puts at risk a lot of regulation that has been with us for a very long time and which I think most people, including most judges, probably think is appropriate. So maybe lower courts won’t adopt the broadest reading of Sorrell.

On the other hand, there are, as I say, a lot of very powerful interests pushing this broad reading of the case and they have managed to attract to their side some high powered names like Floyd Abrams which tends to increase the argument’s legitimacy even though, as I say, if you think about this civil rights for big corporations argument it sounds pretty ridiculous. One scholar titled an article on this topic, “Free the Fortune 500!” and I think that title captures the absurdity of casting pharmaceutical companies as oppressed minorities who, without the intervention of the courts, would not have a voice. The pharmaceutical companies seem like they have plenty of influence with respect to legislation.

Pharmalot: So are we headed to the point where any business will be able to say anything without regulation?
Piety: I don’t know. I hope not. But I think as a society, at least folks my age and younger, see the civil rights struggle as an iconic struggle for justice and so that rhetoric strikes most people as correct when they hear it. So when they hear the drug companies arguing, “Hey! How come everybody gets to talk about these off-label uses but us?”, they think, “Yeah, that’s right. That’s not fair.” But the answer is the reason the companies are treated differently is because they have a financial incentive to slant the information in a particular way and they are in a position of superior knowledge vis-á-vis the public because they manufacture the product and so we want to subject what they say in order to sell that product to more exacting scrutiny than we would the criticism (or praise) from a party without a financial interest.

This is utterly routine in many area of the law. For instance, judges with a financial interest in a case before them should recuse themselves; members of a board of directors with a financial interest in a transaction typically are required to disclose that interest; witnesses’ testifying in court can have their credibility impeached with the fact that they have a financial stake in the outcome, we treat uses of copyrighted material for a commercial purpose as infringement and those for an academic purpose as fair use – and on and on. Until very recently we also thought it appropriate to treat commercial speech differently under the First Amendment. And however appealing the anti-discrimination rhetoric, I don’t think most people recognize where this idea could potentially take us or how it might endanger consumer protection regulations.

Pharmalot: What might this do to the FDA then?
Piety: I’m concerned about the FDA’s ability to engage in appropriate regulation. I don’t have strong feelings one way or another about off label marketing, in part because I just don’t know enough about the subject. But I’m inclined to think that it is a good idea to have an agency such as the FDA engaging in oversight of the industry and I fear that Sorrell might signal diminished effectiveness of its ability to control deceptive practices or practices that are in other ways counter to the public interest.