The Ban on Off-Label Promotion after Sorrell v. IMS Health

Photo by woodleywonderworks via Flickr

In the wake of Sorrell v. IMS Health, in which the Supreme Court invalidated on First Amendment grounds a Vermont law barring drug companies from using physician-specific prescribing data to craft physician-specific sales pitches, lawyers on both sides of the case have weighed in on the opinion’s implications for the Food & Drug Administration’s ban on off-label promotion.  In doing so, they build upon an exchange between the dissent and the majority in Sorrell.  Writing in dissent, Justice Breyer argued that the fact that the Vermont ban is “speaker-based” (i.e., that it only applies to drug companies) should not mean that it is subject to heightened scrutiny, because in the regulatory context it is not unusual for rules to apply only to regulated entities.  By way of example, Justice Breyer cites the ban on off-label promotion, which limits what manufacturers but not others can say to doctors about unapproved uses.  In response, the majority suggests that the government “might defend” the ban on the ground that it “will prevent false or misleading speech.”  The majority then reiterates that Vermont’s interest in banning data mining “instead turns on nothing more than a difference of opinion” between the state and the companies about the truthful marketing messages to which doctors should be exposed.

In an article for BNA’s Pharmaceutical Law & Industry Report, Lisa Blatt and colleagues (who represented PhRMA, one of the respondents in the case) contend that: “Sorrell builds on prior Supreme Court precedent in establishing a strong foundation to argue that a pharmaceutical company’s truthful, non-misleading information about its products cannot be subjected to content-based and speaker-based restrictions.”  And they predict (correctly) that “[t]he implications of Sorrell for the FDA’s off-label promotion regulatory regime may be tested in litigation, as well as in new regulations, in the months ahead.”  On July 14, 2011, as reported here, the Second Circuit ordered supplemental briefing on the implications of Sorrell for its pending decision in United States v. Caronia, a criminal case in which a sales representative was convicted of conspiring to misbrand the sleep aid Xyrem by promoting it for a number of off-label uses.  On the regulatory front, on July 5, 2011, seven leading pharmaceutical companies filed a citizen petition asking “the Commissioner of Food and Drugs to clarify FDA regulations and policies with respect to manufacturer dissemination of information relating to new uses of marketed drugs and medical devices.”

In a very provocative blog post at The Incidental Economist, Kevin Outterson (who wrote an amicus brief on the side of the petitioner in Sorrell on behalf of, among others, the New England Journal of Medicine) appears to concur with Blatt that “[i]n the wake of Sorrell … we can expect the FDA to relax rules against off-label promotion.”  Professor Outterson characterizes the Supreme Court’s decision as a radical adjustment of the regulatory balance between the FDA and the companies it regulates.  Under our current system, data on the safety and efficacy of drugs is largely generated privately, as a condition of marketing approval.  The ban on off-label promotion is a key component of the system, because it provides manufacturers with a powerful push to continue to study their products after they are initially approved for sale.  Without it (or, even more radically, without any requirement that a manufacturer establish that a drug is efficacious before marketing it), we’ll either need to find other ways to incentivize private sector research or spend more public money on the study of drugs, both easier said than done.  Professor Outterson suggests a third way, that: “the US could simply free ride off the studies produced to satisfy Europe’s Phase III approval process.”  As he points out, however, “[t]hat would work only so long as the EU didn’t make the same changes.”

Perhaps naively, I am hopeful that the ban on off-label promotion will survive the coming wave of legal challenges largely intact.  In addition to its role in incentivizing research (a neutral function which distinguishes it from the data mining law at issue in Sorrell), I think that the ban serves as an important prophylactic against false and misleading product promotion.  (I elaborate on this argument here.)  This preventive role further distinguishes the ban on off-label promotion from the law invalidated in Sorrell.

Power, Knowledge, and Big Pharma: Preliminary Reflections on the Sorrell Vacuum

I have previously commented on Sorrell v. IMS Health, as a co-author of an amicus brief, a Pharma FaceOff panelist, and a blogger. I’m disappointed by the Sorrell ruling, for reasons largely elaborated in Justice Breyer’s dissent. As he observes, the majority opinion “reawakens Lochner’s pre-New Deal threat of substituting judicial for democratic decision-making where ordinary economic regulation is at issue.” But I’m not surprised at the Lochner revival, given the First Amendment maximalism of the Citizens United Court. For this Court, “free expression” will have to do in the information age what “freedom of contract” did for the early decades of the 20th century: erase even small and incremental steps toward a fairer social order.

Bill McGeveran has characterized Kennedy’s majority opinion in the case as relatively limited, a surgical strike against an overreaching and incompetent state legislature. I want to respond to his interpretation in a future post, after I’ve digested the opinion a bit more. But for now, I’d like to focus a bit of attention on the types of problems Vermont was addressing, to give the case more of a human face. For behind all the familiar Kennedy rhetoric about sacred speech, deeply disturbing industry practices motivated Vermont’s law.

Both PhRMA and IMS Health want us to believe that the case is about the life-saving power of a marketer to recommend drugs to oblivious doctors once it has access to their prescribing records. Never mind that, as Dr. David Orentlicher notes, “For $98 a year . . . physicians can subscribe to The Medical Letter on Drugs and Therapeutics, a respected and independent, biweekly newsletter that provides evaluations of prescription (and over-the-counter) drugs.” Maybe detailing, on occasion, saves lives. But, as the dissent observes, Vermont’s law allowed doctors to permit distribution of their prescribing records in order to receive personalized solicitations. They only needed to opt in.

Now why did Vermont doctors petition the state to limit access to prescriber records? And why might a rational physician choose not to opt in? Hundreds of pages of empirical studies show the problems caused by detailing; many are cited in Breyer’s dissent. But to make the situation a little more concrete, consider some of the literature a physician who rarely prescribes, say, pscyhotropic drugs, may now be reading. These examples are all drawn from two recent pieces by Marcia Angell in the NYRB:

A large survey of randomly selected adults, sponsored by the National Institute of Mental Health (NIMH) and conducted between 2001 and 2003, found that an astonishing 46 percent met criteria established by the American Psychiatric Association (APA) for having had at least one mental illness within four broad categories at some time in their lives. . . . The new generation of antipsychotics, such as Risperdal, Zyprexa, and Seroquel, has replaced cholesterol-lowering agents as the top-selling class of drugs in the US. . . . [Author Robert Whitaker] is outraged by what he sees as an iatrogenic (i.e., inadvertent and medically introduced) epidemic of brain dysfunction, particularly that caused by the widespread use of the newer (“atypical”) antipsychotics.

***

The pharmaceutical industry influences psychiatrists to prescribe psychoactive drugs even for categories of patients in whom the drugs have not been found safe and effective. [There has been an] astonishing rise in the diagnosis and treatment of mental illness in children, sometimes as young as two years old.

The FDA approves drugs only for specified uses, and it is illegal for companies to market them for any other purpose—that is, “off-label.” Nevertheless, physicians are permitted to prescribe drugs for any reason they choose, and one of the most lucrative things drug companies can do is persuade physicians to prescribe drugs off-label, despite the law against it. In just the past four years, five firms have admitted to federal charges of illegally marketing psychoactive drugs. AstraZeneca marketed Seroquel off-label for children and the elderly (another vulnerable population, often administered antipsychotics in nursing homes); Pfizer faced similar charges for Geodon (an antipsychotic); Eli Lilly for Zyprexa (an antipsychotic); Bristol-Myers Squibb for Abilify (another antipsychotic); and Forest Labs for Celexa (an antidepressant).

Despite having to pay hundreds of millions of dollars to settle the charges, the companies have probably come out well ahead.

Whereas IMS Health’s counsel described detailing in oral arguments as “information about lifesaving medications where the detailer goes in and talks about double blind scientific studies that are responsible for the development of drugs that have caused 40 percent of the increase in the lifespan of the American public,” Angell marshals an impressive array of evidence on the unreliability of pharma marketing, and even the underlying studies some of it is based on. Angell also compiles surprising details about the pervasive role of pharmaceutical firm influence over the social construction of mental illness. When you consider the industry’s targeting of “key opinion leaders” (professors and practitioners at elite medical centers), civil society groups, and the DSM, Vermont’s law seems an almost trivial response to a juggernaut of profit-driven promotions for mind cures. And yet even that small step (toward allowing physicians more control over how they are approached by detailers) offended the delicate sensibilities of the majority.

The Breyer dissent’s litany of regulated industry information practices should have dampened Kennedy’s abstracted enthusiasm for a “commercial marketplace” that “provides a forum where ideas and information flourish.” But in the vacuum of First Amendment fundamentalist thought, the complex ecology of fair information practices and calibrated disclosure cannot survive. It’s all-or-nothing: as soon as some parties gain access to prescriber data, everybody has to have it. Doctors can’t choose to structure their interactions with detailers based on profiling of their practices; rather, they face the stark choice of letting in marketers with access to all the prescribing practice data the state requires pharmacies to maintain, or not to talk to them at all.

In Sorrell, privacy and free expression become clashing rights, rather than social values that have long been reconciled (and occasionally reinforced one another) in complex regulatory schemes. We need to maintain that tradition of nuance in information law. Sadly, Sorrell turns its back on it.

The Identity Theft Smoke Screen: Data Mining of Prescription Drug Records and Personal Data Privacy

[Ed Note: We are pleased to welcome a guest article from Christopher J. Asakiewicz, J.D. He graduated from Seton Hall Law in 2011 with a concentration in Health Law, recently passed the New York Bar Exam (congratulations!) and works for ImClone Systems Corporation, an affiliate of Eli Lilly and Company, drafting and negotiating various clinical documents and patient disclosures with both US and ex-US institutions as well as central and local investigational review boards (IRBs). During law school he worked  at Saint Vincents Catholic Medical Centers of New York (SVCMC) in the department of legal affairs, and prior to pursuing a legal education, managed phase IIIB/IV international clinical trials for Pfizer Inc. in the areas of neurology and neurodegenerative diseases.]

Personal data privacy once again has taken front stage in Sorrel v. IMS Health, Inc.[1] Vermont passed the Vermont Confidentiality of Prescription Information Law that allows doctors which prescribe drugs to patients, to decide whether pharmacies can sell their prescription drug prescription records.[2] IMS Health as well as other health information companies contested the law, arguing that the law poses a restriction on commercial speech as access to such information helps pharmaceutical companies market their drugs effectively to doctors. The Supreme Court is now tasked with determining the constitutionality of the restriction on access to prescription information with regards to our First Amendment. [3]

However, this post is focused on the secondary effects asserted in amici curiae briefs supporting the petitioners of allowing companies to purchase such information, specifically the concern of data privacy and patient re-identification. [4] Under the Health Information Portability and Accountability Act (HIPAA), personal health information is de-identified by your local pharmacy prior to such information being shared with any third party. By de-identifying the data, your personal data cannot, it is believed, be linked or traced back to you. De-identifying your health information is a way for covered entities to share your information without your consent or authorization and in accordance with the law. The information once shared is completely anonymized. After the transfer to a third party, like IMS Health, your information is solely data of zeros and ones that translate to dates of dispensing and drug names. No longer does your prescription record list your name or month or day of birth. [5]

Briefs in the case assert that data mining firms could, hypothetically, create profiles based on these de-identified prescription records. Such prescription profiles would constitute certain patient’s prescription habits, including an individual’s medication types, pharmacies visited and dates dispensed. The briefs argue that linking and mining further public information to these drug profiles could result in patient re-identification.

IMS Health, Inc., of course, asserts that it has no knowledge of any patient re-identification and it protects such records with all the security privacy measures set forth under HIPAA and as strengthened by Health Information Technology for Economic and Clinical Health Act (HITECH). So what is the issue, I ask?

A pharmaceutical company does not need nor want to know who you are. Aggregate data is more beneficial to a marketing company, rather than just one record with your name on it. What benefit would a company get from a record that says, John Doe, DOB: 01-Jan-1984? The company could send you a mailer, but under the current regulations, you can opt out of the marketing material and it stops there. However, what helps a pharmaceutical company is aggregate datasets that say Dr. Jane Doe, MD writes 100 scripts for Lipitor ® a month. No one cares if the patients are unidentifiable, and most likely, the pharmaceutical company wants to keep it that way. Not only will the de-identified data be cheaper to buy, but it also assures the third party purchasing the data that it is not aiding a HIPAA violation.

Last, it is also asserted that there is no penalty for re-identification of personal health data, but there are stark penalties under HIPAA for “a person who knowingly … (1) uses or causes to be used a unique health identifier; (2) obtains individually identifiable health information relating to an individual; or (3) discloses individually identifiable health information to another person.” [6] If the offense is committed with the intent to sell, transfer or use the individually identifiable health information for commercial advantage, the penalty could be up to $250,000 and 10 years imprisonment. [7] If claims are brought against companies, like IMS Health, the companies will surely argue they are not covered entities subject to the penalties under HIPAA; however, this does not prevent civil lawsuits against them.

What will happen if a breach occurs due to patient re-identification? Most likely, the current healthcare environment where many companies are acting under corporate integrity agreements or deferred prosecution agreements, promotes reporting, if not out of altruistic purpose at least a compliance purpose. With this said, once reported to both the Department of Health and Human Services, Office of Civil Rights, as well as, in most states, the Secretary of state, privacy and confidentiality laws require notification to be provided to the patient that has been re-identified. This patient whose privacy rights have been infringed can then bring an individual civil claim against the organization responsible for the disclosure of their health information as well as the collateral damages caused by the unauthorized disclosure. Now, what company today wants to get involved with this type of bad publicity?

In conclusion, just because the possibility exists that a patient can be re-identified with data mining practices, does not mean that our current environment will foster such. The nine Justices of the Supreme Court need to be more concerned with the First Amendment and the commercial speech implications of their ruling, rather than amici curiae briefs supporting public policy positions based on unwarranted fears of patient information disclosure.[8]

I therefore urge you to put yourself in the role of your favorite Justice and consider if you should be more concerned that a company is going to buy your prescription records and try to determine that you took amoxicillin for a sinus infection when you were five years old, or if that company would rather purchase all the information you posted on Facebook ® or other social networking sites, including all the locations you have checked in. Which do you think is more useful to market its products? It is with this mindset that you must consider if the regulation directly advances the governmental interest “in protecting the public health of Vermonters, … the privacy of prescribers and prescribing information” and is no more extensive than necessary to serve that interest. [9]

[2] Vt. Stat. Ann. tit. 18, § 4631 (2010).

[3] See Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980).

[4] Brief of Electronic Privacy Information Center (EPIC) et. al. as Amici curiae supporting Petitioners, Sorrel v. IMS Health, Inc., 131 S. Ct. 857, (2011) (No. 10-779), 24-9, available at, http://www.atg.state.vt.us/assets/files/10-779%20EPIC%20amicus%20Sorrell.pdf; Latanya Sweeney, Simple Demographics Often Identify People Uniquely (Carnegie Mellon University, Data Privacy Working Paper No. 3, 2000), available at, http://dataprivacylab.org/projects/identifiability/paper1.pdf.

[5] Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Pub. L. No. 104-191 (1996), 45 C.F.R. §§ 164.312(e)(2)(ii), 164.514(b)(2)(i) (2010).

[6] 42 U.S.C. § 1320d-6(a)(1)-(3).

[7] Id. § 1320d-6(b).

[8] Brief of Electronic Privacy Information Center (EPIC) et. al. as Amici curiae supporting petitioners, Sorrel, 131 S. Ct. 857, (No. 10-779).

[9] See Vt. Acts & Resolves No. 80, § 17 (2007) (Confidentiality of Prescription Information); Vt. Acts & Resolves No. 89, § 3 (2008) (amending Act 80).

Rethinking IMS Health v. Sorrell: Privacy as a First Amendment Value

Today the Supreme Court will hear oral arguments in IMS Health v. Sorrell. The case pits medical data giant IMS Health (and some other plaintiffs) against the state of Vermont, which restricted the distribution of certain “physician-identified” medical data if the doctors who generated the data failed to affirmatively permit its distribution.* I have contributed to an amicus brief submitted on behalf of the New England Journal of Medicine regarding the case, and I agree with the views expressed by brief co-author David Orentlicher in his excellent article Prescription Data Mining and the Protection of Patients’ Interests. I think he, Sean Flynn, and Kevin Outterson have, in various venues, made a compelling case for Vermont’s restrictions. But I think it is easy to “miss the forest for the trees” in this complex case, and want to make some points below about its stakes.**

Privacy Promotes Freedom of Expression

Privacy has repeatedly been subordinated to other, competing values. Priscilla Regan chronicles how efficiency has trumped privacy in U.S. legislative contexts. In campaign finance and citizen petition cases, democracy has trumped the right of donors and signers to keep their identities secret. Numerous tech law commentators chronicle a tension between privacy and innovation. And now Sorrell is billed as a case pitting privacy against the First Amendment.
Read more

Under the Radar: Health Care Reform & Drug Advertising & Marketing

Photo by wenzday01 via Flickr

At the Food and Drug Law Institute’s 21^st Annual Advertising & Promotion Conference John Kamp of the pro-industry Coalition for Healthcare Communication discussed four proposals addressing drug advertising and marketing issues that may be incorporated into the final health care reform bill but have not been widely debated.  Mr. Kamp’s presentation is available here.  

Off the Table (For Now)

Of most concern to industry is an oft-floated proposal to eliminate the tax deduction for drug advertising.  (See, for example, bills sponsored by Representative Jerrold Nadler (D-NY) and Representative Daniel Lipinski (D-IL) here and here.)  Most recently, on September 11, 2009 Senator Bill Nelson (D-FL), a member of the Senate Finance Committee, announced his plan to put forth an amendment to the Baucus Bill that would eliminate the “tax break drugmakers get for TV advertising.”

Direct-to-consumer advertising is a prime target because, as the New York Times put it, for many “the ads are a daily reminder of a health care system run amok,” which “prompt people to diagnose themselves with chronic quality-of-life problems like insomnia or restless leg syndrome; lead people to pressure their doctors for prescriptions for expensive brand-name drugs to treat these conditions; and steer people away from cheaper generic pills.”   There is also concern that DTC ads do not present an accurate picture of drug risks and benefits and that they drive uptake of new drugs before their safety is fully known.

Another obvious driver is the need to pay for health care reform.  Senator Nelson echoed a claim made earlier this year by Congressman Charles Rangel (D-NY) that eliminating the tax break for TV ads would free up $37 billion over the next ten years.  Industry representatives contest the $37 billion figure, arguing that drug companies spend far too little on direct-to-consumer advertising to achieve that level of additional tax revenue.  They contend that Congress would have to eliminate the tax deduction for physician advertising and other marketing expenditures to garner $37 billion.

Less than a week after he announced it, Senator Nelson backed off his plan, perhaps under pressure from other members of Congress who come from districts with a strong media presence and have spoken out against eliminating the deduction.  According to Mr. Kamp, however: “Somebody else will raise this again before it’s over, you bet … Baucus says the reforms will cost $850 billion, the Congressional budget office $750 billion. Three-quarters of a trillion dollars is a lot of real money in Washington. The $37 billion will continue to be in the buffet of options as they try and figure out healthcare.”  

Still on the Table

Three proposals related to drug and device promotion are still on the table, with varying chances for inclusion in the final health care reform bill.

First, health care reform bills in both the House and the Senate contain transparency provisions akin to those in the Physicians Payments Sunshine Act of 2009 introduced in January by Senator Chuck Grassley (R-IA).  Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy recommended that disclosure of drug and device company payments to doctors be federally mandated in its January 2009 white paper.  As the Sunshine Act has widespread support, including from industry, transparency provisions are likely to be included in the final bill.

Second, Section 138 of the health care reform bill reported out of the House Education and Labor Committee   bans the commercial use of “prescription information containing patient identifiable and prescriber identifiable data,” essentially adopting as federal law New Hampshire’s ban on prescription data mining which survived a First Amendment challenge in the First Circuit.  If passed, Section 138 would end drug reps’ current practice of tailoring their sales messages to each doctor’s prescribing history, which many believe creates undue pressure on doctors to prescribe newer more expensive medications.

Third, a bill sponsored by Senator Jack Reed (D-RI) would authorize the FDA to evaluate whether use of a “drug facts box” format for presenting a drug’s benefits and risks would improve healthcare decision making and, if so, to promulgate regulations requiring that drug facts boxes be added to drug labels.  Senator Reed’s bill also empowers the FDA to set standards for comparative clinical effectiveness information included in drug labeling and advertising.

It is difficult to predict whether the data mining ban or Senator Reed’s bill will be included in the final health care reform bill.  Mr. Kamp calls Senator Reed’s bill’s chances a “toss up;” regarding the data mining ban, he has “no idea.”