Par Pharma: Free Speech Muffled By The FDA
23 CommentsBy Ed Silverman // October 17th, 2011 // 9:02 am
In yet another clash between the pharmaceutical industry and the FDA over discussing prescription drug usage with doctors, Par Pharmaceutical has filed a lawsuit contending that its ability to convey “truthful” information to physicians is protected by the First Amendment, yet is thwarted by agency regulations governing off-label promotion.
At issue, Par argues, is its ability to talk to physicians who may prescribe one of its drugs for unapproved uses. The drug in question is Megace ES, which was approved by the FDA in 2005 to treat anorexia, cachexia or unexplained weight loss in AIDS patients. Par notes that doctors prescribe Megace to treat wasting in other patients, such as the elderly or those with cancer.
The drugmaker “contends that the government’s effort to minimize off-label use by means of banning Par’s truthful speech is unjustified since off-label use is lawful, widespread, medically necessary and reimbursed by the federal government under the Medicare and Medicaid programs,” Par says in a statement. “Through its suit, Par hopes to elicit tailored and constitutionally permissible regulatory guidance to ensure that physicians may be kept abreast of valuable, on-label information about prescription drugs to aid in their provision of quality and informed patient care” (here is the lawsuit and a motion for preliminary injunction).
This is not the first time that a drugmaker has gone to court and charged that FDA regulations run roughshod over commercial free speech. Allergan did the same thing two years ago, but to resolve a criminal and civil investigation, the drugmaker agreed to dismiss its First Amendment lawsuit (here it is) in which it sought to win the right to distribute information about unapproved uses for Botox in the context of providing scientific and medical info to doctors. Allergan claimed an FDA ban on off-label marketing violates its First Amendment rights to free speech (back story).
The overriding issue is also being debated in a case involving a former sales manager for Orphan Medical, which obtained FDA approval to market its Xyrem drug to treat cataplexy, an affliction marked by a sudden loss of muscle tone associated with narcolepsy. However, docs soon began prescribing the med to treat other conditions and Alfred Caronia, a former Orphan sales exec, was convicted three years later of encouraging docs to engage in off-label usage (back story). The US Court of Appeals for the Second Circuit is reviewing the conviction and the commercial speech issue, especially in light of the recent US Supreme Court ruling that struck down a Vermont data mining law, in part, over free speech (see here).
pic thx to newtown graffiti on flickr
original industry insider
I’ve never trusted Par since they were enmeshed in the Generic Drug Scandal of 1990.
http://articles.latimes.com/1990-01-12/business/fi-465_1_generic-drug
Observer
I deny their first premise …
“since off-label use is lawful, widespread, medically necessary and reimbursed by the federal government under the Medicare and Medicaid programs,” Par says in a statement.”
It isn’t LAWFUL which is why they are going through this process…. at least IMHO.
J
Observer,
Doctors prescribe drugs off-label all the time and it’s perfectly within their legal rights to do so…
It’s a company’s _promotion_ of an off-label use for one of their products that isn’t lawful.
Justice in MI
Yes, I understand about 1/4 of scripts are off-label, of which about 75% have no supporting scientific evidence or, in fact, negative scientific evidence of efficacy.
One of my “favorite” internal documents released via the Lilly/Zyprexa litigation is a slide in which marketeers are anticipating the impact of being able to spread the Zyprexa Gospel if the Washington Legal Foundation succeeded via the Supreme Court to get the restrictions on off-label promotion rescinded.
How many people believe this is sincerely about patient care?
Observer
Justice - for a number of years, the common wisdom was that 50 % of scripts (= or - 10) were off-lable. Things must be improving?
J - thank-you for clarifying the sttement, it isn’t legal for them. Which, again, is the point of their action.
Justice in MI
Yes, 50% appears to be mythology, convenient for certain purposes.
According to an Archives study in 2006, the actual number was about 20% (less than I suggested), with 75% of those having no significant evidence of efficacy. See one summary here:
http://www.sciencedaily.com/releases/2006/05/060513122427.htm
So I doubt things are “improving” in this regard. “Common wisdom,” as happens, is dis/misinformation.
Beyond dis/misinformation, one of the reasons we tend to assume the number is larger is because of certain high profile cases. Neurontin, for example, was rx’d about 86% off-label.
Also, many docs frankly don’t know one way or other, especially once “word gets around.”
How does that happen, I wonder.
Salient point
A good case can be made that FDA restrictions are an abrogation of a company’s 1st amendment rights.
I’m not sure, though, that these are the guys to make it. If Par is being restricted from discussing “approved use” of its product, as the filing maintains, why does its statement refer to free speech rights extending to off-label use?
AnnePME
While I agree that there is a lot of misuse of off label marketing, going to far and basing this arguement on free speech bothers me. I think about how Plaquenil was discovered to be a useful tool in treating autoimmune disease by accident in WWII when it was given to prevent Malaria in the troops. Troops with Lupus reported benefits, and Plaquenil went on to become and it remains in use as a treatment for certain autoimmune diseases.
Justice in MI
Anne, wondering what you think would be a good system. How did the word about Plaquenil “get out”?
Renee
Glad to hear from Anne that doctors discovered other beneficial uses for Plaquenil. The key words here are “doctors” and “useful:. Lilly’s Zyprexa conniving was cited earlier - their off-label marketing of this very dirty psych. drug had to do with nothing but sales and market share…as the word was getting out about the fact that the drug’s side effects were the worst in its class, the Marketing Department took over, manufacturing fake patient profiles with fake and non-existent psychiatric diagnoses. 4,000 dead and counting.
Healthy Perspective
The 1st Amendment never gave anyone the right to claim something that is untrue; there were laws against fraud and adulteration from the earliest days of our republic. If fraudulent commercial marketing were protected under the First Amendment, courts over the past two centuries would have had plenty of laws to overturn. They did not. Stare decisis and the historical meaning of the Amendment should clearly issue in a rejection of Par Pharmaceutical’s suit.
If you claim that “product X heals disease Y,” we have a simple way in the 21st century of proving whether your claim is true: a randomized, controlled trial. If you claim that X heals Y without that evidence, you are engaging in fraud.
Meaning of Constitution. Check.
Modern science. Check.
End of story.
…though I suspect the new judicial hack-tivists on the Roberts Court will find a way to slowly twist our Constitution to fit their Randian dreams.
cliffintokyo
Off label positive outcomes are ALL anecotal.
Do the study! DuHH!
Salient point
Healthy Perspectives-Actually FDA typically requires at least two such trials for approval & promotion, although there are sometimes exceptions for new indications or rare diseases.
Furthermore, it’s only fraudulent to say something is true when it demonstrably isn’t. Which isn’t the same as saying a product has been shown to have an effect in a given disease even though FDA hasn’t approved it for that indication.
In pharmaceuticals, the burden of proof is always on the product to demonstrate something is true, per FDA guidelines. In most other commercial communications (political ads leap to mind, as an example) the burden is on FCC to demonstrate something is false. That’s a genuine difference.
Perhaps this is as it should be. But tossing around the word “fraudulent” is not appropriate.
Justice in MI
I appreciate some of the distinctions–what has and hasn’t gone through (or been submitted for) FDA approval process–but the following seem to me rightly categorized as fraudulent, although they are not the same:
–Claiming a benefit when the company knows there is no evidence that supports the claim.
–Claiming a benefit when co. knows there is evidence specifically against the claim.
Of course, I’m speaking in terms of common parlance, not legal definition.
Is there agreement that either of the above would constitute fraudulent communication?
Relatedly, as I understand the Neurontin strategy, the plan was specifically NOT to apply for wider indications and save those for “new, improved” Lyrica. Meanwhile, Neurontin was doing so well through fraudulent promotion with 86% off-label rx’ing (it was called “snakeoil” even within company communications) that there was no need to push further. The majority of off-label rx’ing meanwhile, had zero or negative evidence of efficacy. And so pts who might have received effective tx–for bipolar, for example–were provided, in essence, nothing…or less than that.
Healthy Perspective
Sal Point: Using the word fraudulent is “appropriate” indeed, as it invokes a longstanding (think English common law and I humbly suggest looking it up) legal tradition, from which FDA’s powers and those of many health agencies issue.
“Actually FDA typically requires at least two such trials for approval & promotion.” This is an academic distinction without a true difference. They could require three, they could require just phase 1, or phase 2. The key is that a constitutionally endowed actor — the U.S. Congress, through laws signed by the President, many decades ago, has delegated this power of what constitutes proof to the FDA.
“Furthermore, it’s only fraudulent to say something is true when it demonstrably isn’t.” And here you misunderstand the basic notion of modern science, that of the null hypothesis. The null hypothesis of science and modern medicine means that what you claim to be true is not so unless you prove it to be, using accepted empirical standards. That is why the court of science and medicine differ from the court of law, and why basic principles of physicians and pharmacology are not decided at the Supreme Court (thank God).
“In pharmaceuticals, the burden of proof is always on the product to demonstrate something is true.” And not just in pharmaceuticals but also in food (so if you claim your corn is “organic,” if you claim you are selling Champagne as opposed to sparkling wine, if you claim you are a professional attorney or accountant, you have to get pre-market certification).
And please let’s not compare the FCC and and the FDA. Courts, and governments cor centuries have long drawn a distinction between the police power of the state in public health and the regulation of communications and media.
Salient point
Healthy Perspective-I guess the executive & legislative branches are “constitutionally endowed,” whatever that means. Of course, the judiciary is too. The Supreme Court has yet to weigh in on this specific issue. Perhaps it sees no reason to, or the right case hasn’t made it that far yet.
I know all about the null hypothesis, a lot more than you do, probably. It has nothing to do with the law, of course, which is what I was writing about. But thanks for the head’s up!
Salient point
JiM-I’m afraid we probably disagree on how isolated the Neurontin case is from what typically goes on, especially nowadays. But can’t argue with your premise.
Dissident
This is not a close call. If Par is subject to punishment for truthful marketing speech, which is what it alleges, that violates the First Amendment. If Par makes false or misleading statements to doctors or others about the efficacy or safety of its drugs, that is fraud and can be punished. Also, prohibiting a company from exercising its constitutional right to speak truthfully unless it complies with some regulation is itself unconstitutional. That is what is known as an unconstitutional condition. If the government does not think a drug should be prescribed for a particular off label use, it should prohibit that act. But, once it decides to allow prescriptions for such off label use, it may not punish anyone that engages in non-fraudulent discussions about it, e.g., like the commentators on this blog.
Any questions?
john
I think this is an interesting and not completely straightforward issue. There is indeed something odd about off-label promotion being illegal when off-label prescribing is not.
The implication seems to be that physicians (one of the most highly educated and compensated professional groups in our society), will make better decisions if they are “protected” from certain commercial messages. The only comparable legislation I am aware of is a bill that was shot down in the House of Representatives 15 years or so ago that would have banned advertisements directed at children.
Having said all that, I do believe that bans on off-label prescribing serve one important purpose: to force manufacturers to perform clinical trials in the indications that they expect the drug to be used in, and not just in a single indication for which there is a low barrier to approval.
Dissident
There is hierarchy of rights in this country. Right at the top is the Bill of Rights. Would it be OK to deny a company its right to a jury trial or its employees their right to vote because it didn’t test a drug that was being legally used for off label use? If the FDA wants drug companies to do the testing for a particular drug if, say 10% of the prescriptions written are for an off label use, it should compel it to do the tests or face a fine. Or the government can impose a special tax based upon the number of prescriptions written for off label use. It should not threaten to punish the company for truthful speech in order to induce it to do the testing.
harpy
with all of the information available on this blog and throughout the interwebs, I am astounded there are still people who will take a pharmaceutical company at its word that drug X will work for condition Y.
companies are allowed to discuss off-label usage under strictly controlled circumstances. this whinging about corporate free speech rights is disgusting.
Norman Invasion
Odd arguments here. Nothing in the Constitution, or subsequent jurisprudence, says that “the Bill of Rights” is “right at the top” of some constitutional hierarchy. Art. 1 sec. 8 allows Congress to regulate interstate commerce; no single right trumps that power or any other in Sec. 1 — see Schenck v U.S. — and, to be consistent, nothing in the commerce clause power necessarily trumps the Bill of Rights. It’s for us who are alive, not dead, to figure out the balance.
Harpy, Dissident and, less so, Healthy P have a point when they say this is about fraud. The real legal question gets down to what is “truthful” and what is “false”; when science weighs in on the answer, the courts have historically been willing to turn this kind of matter over to Congress/FDA (delegation doctrine).
The relevant constraints on FDA restriction of off-label promotion that exist, here and now, have to do with companies ability to distribute a _published_ medical study that may show evidence of efficacy or safety. But let’s be real; nothing gives a company the ability to advertise that “Bye-bye-Tumor” cures prostate cancer just because there is no clear evidence that “By-bye-Tumor” _doesn’t_ cure PC.
Despite Healthy P’s horrific fantasies, the Court won’t create a right to say anything; they usually turn this over to the scientists.
Dissident
There is a hierarchy in the sense that an amendment to a document trumps whatever came before it. Thus, the fact that Congress was originally given the power to regulate interstate commerce is limited by its ability to punish truthful commercial speech. No one is arguing that a drug company may not be punished for promoting its drugs for off label use by presenting false or misleading information. But, that is not what the FDA typically alleges in charging companies with marketing drugs for off label use. Instead, it says a company cannot exercise its right to engage in truthful speech until it obtains the FDA’s approval. But, exercising one’s constitutional rights may not be conditioned on government approval. That is why they call them “rights.”