Although there have been numerous articles written regarding the outcomes of several recent rulings of the Supreme Court of the United States (SCOTUS), it is a worthwhile exercise to review firsthand the SCOTUS ruling regarding the rights of pharmaceutical companies and their representatives to free speech in the marketplace.
What is Free Speech?
The First Amendment states that “Congress shall make no law abridging the freedom of speech or the press, or the right of the people to peaceably assemble”. While the First Amendment has generally been interpreted to apply to an individual’s right to “free speech”, there is also protection granted to “commercial free speech”:
Commercial free speech is speech done on behalf of a company or individual for the intent of making a profit. It is economic in nature and usually has the intent of convincing the audience to partake in a particular action, often purchasing a specific product. Generally, the United States Supreme Court defines commercial speech as speech that “proposes a commercial transaction.” The idea of “Commercial Speech” was first introduced by the Supreme Court when it upheld Valentine v. Chrestensen (1942). In upholding the regulation, the Supreme Court said, “We are … clear that the Constitution imposes … no restraint on government as respects purely commercial advertising.” (1)
Regarding the relative importance of non-commercial individual “free speech” versus “commercial free speech”, Justice Clarence Thomas replied, in 44 Liquormart, Inc. v. Rhode Island (1996), that “I do not see a philosophical or historical basis for asserting that ‘commercial’ speech is of ‘lower value’ than ‘noncommercial’ speech.” (1)
The State of Vermont’s Legislation to Suppress Pharmaceutical Marketing
Vermont found that the “goals of marketing programs are often in conflict with the goals of the state” and that the “marketplace for ideas on medicine safety and effectiveness is frequently one-sided in that brand-name companies invest in expensive pharmaceutical marketing campaigns to doctors.” Detailing, in the legislature’s view, caused doctors to make decisions based on “incomplete and biased information.”. Because they “are unable to take the time to re-search the quickly changing pharmaceutical market,” Vermont doctors “rely on information provided by pharmaceutical representatives.” The legislature further found that detailing increases the cost of healthcare and health insurance, encourages hasty and excessive reliance on brand-name drugs, before the profession has observed their effectiveness as compared with older and less expensive generic alternatives, and fosters disruptive and repeated marketing visits tantamount to harassment. The legislative findings further noted that use of prescriber-identifying information “increase[s] the effect of detailing programs” by allowing detailers to target their visits to particular doctors. Use of prescriber-identifying data also helps detailers shape their messages by “tailoring” their “presentations to individual prescriber styles, preferences,and attitudes.” (2)
The state of Vermont therefore passed law §4631 or Act 80 which stated:
“A health insurer, a self-insured employer, an electronic transmission intermediary, a pharmacy, or other similar entity shall not sell, license, or exchange for value regulated records containing prescriber-identifiable information, nor permit the use of regulated records containing prescriber-identifiable information for marketing or promoting a prescription drug, unless the prescriber consents . . . . Pharmaceutical manufacturers and pharmaceutical marketers shall not use prescriber-identifiable information for marketing or promoting a prescription drug unless the prescriber consents . . . .” (2)
While unilaterally prohibiting the sale of prescribing information to pharmaceutical companies, the law did allow the sale of information to allow the state of Vermont to mount educational programs to counter-detail or promote generics:
Act 80 also authorized funds for an “evidence-based prescription drug education program” designed to provide doctors and others with “information and education on the therapeutic and cost-effective utilization of prescription drugs.” §4622(a)(1). An express aim of the program is to advise prescribers “about commonly used brand-name drugs for which the patent has expired” or will soon expire. §4622(a)(2). Similar efforts to promote the use of generic pharmaceuticals are sometimes referred to as“counter-detailing.” The counter detailer’s recommended substitute may be an older, less expensive drug and not a bioequivalent of the brand-name drug the physician might otherwise prescribe. Like the pharmaceutical manufacturers whose efforts they hope to resist, counter detailers in some States use prescriber-identifying information to increase their effectiveness. States themselves may supply the prescriber-identifying information used in these programs.(2)
The SCOTUS Ruling Overturns the Vermont Law
The SCOTUS overturned the Vermont law stating that the law violated the First Amendment by restricting both the content (it restricted the promotion of branded pharmaceutical content) and by restricting the person delivering the content depending upon their identity (it restricted a pharmaceutical representative from delivering the content). The complete contents of the ruling can be found here, what follows are a series of summary statements:
“First, the State contends that its law is necessary to protect medical privacy, including physician confidentiality, avoidance of harassment, and the integrity of the doctor-patient relationship. Second, the State argues that §4631(d) is integral to the achievement of policy objectives—namely, improved public health and reduced healthcare costs. Neither justification withstands scrutiny.”
With respect to the Vermont contention that the dissemination of prescribing information violates a physician’s right to privacy, SCOTUS stated:
“Physicians can, and often do, simply decline to meet with detailers, including detailers who use prescriber-identifying information. Doctors who wish to forgo detailing altogether are free to give “No Solicitation” or “No Detailing” instructions to their office managers or to receptionists at their places of work.” The defect in Vermont’s law is made clear by the fact that many listeners find detailing instructive. Indeed the record demonstrates that some Vermont doctors view targeted detailing based on prescriber-identifying information as “very helpful” because it allows detailers to shape their messages to each doctor’s practice.
With respect to the State’s contention that pharmaceutical marketing is counter to its policy objectives of improved public health and reducing costs SCOTUS stated:
“If pharmaceutical marketing affects treatment decisions, it does so because doctors find it persuasive. Absent circumstances far from those presented here, the fear that speech might persuade provides no lawful basis for quieting it. The State contends that §4631(d) advances important public policy goals by lowering the costs of medical services and promoting public health. If prescriber-identifying information were available for use by detailers, the State contends, then detailing would be effective in promoting brand-name drugs that are more expensive and less safe than generic alternatives. This logic is set out at length in the legislative findings accompanying §4631(d). Yet at oral argument here, the State declined to acknowledge that §4631(d)’s objective purpose and practical effect were to inhibit detailing and alter doctors’ prescription decisions. The State’s reluctance to embrace its own legislature’s rationale reflects the vulnerability of its position. While Vermont’s stated policy goals may be proper, §4631(d) does not advance them in a permissible way. As the Court of Appeals noted, the “state’s own explanation of how” §4631(d) “advances its interests cannot be said to be direct.” The State seeks to achieve its policy objectives through the indirect means of restraining certain speech by certain speakers—that is, by diminishing detailers’ ability to influence prescription decisions. Those who seek to censor or burden free expression often assert that disfavored speech has adverse effects. But the “fear that people would make bad decisions if given truthful information” cannot justify content-based burdens on speech. “The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.” These precepts apply with full force when the audience, in this case prescribing physicians, consists of “sophisticated and experienced” consumers.
“In an attempt to reverse a disfavored trend in public opinion, a State could not ban campaigning with slogans, picketing with signs, or marching during the daytime. Likewise the State may not seek to remove a popular but disfavored product from the marketplace by prohibiting truthful, nonmisleading advertisements that contain impressive endorsements or catchy jingles. That the State finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.”
“The law’s express purpose and practical effect are to diminish the effectiveness of marketing by manufacturers of brand-name drugs. Just as the “inevitable effect of a statute on its face may render it unconstitutional,” a statute’s stated purposes may also be considered. Here, the Vermont Legislature explained that detailers, in particular those who promote brand-name drugs, convey messages that “are often in conflict with the goals of the state.” 2007 Vt. No. 80, §1(3). The legislature designed §4631(d) to target those speakers and their messages for disfavored treatment. “In its practical operation,” Vermont’s law “goes even beyond mere content discrimination, to actual viewpoint discrimination.” R. A. V. v. St. Paul, 505 U. S. 377, 391 (1992). Given the legislature’s expressed statement of purpose, it is apparent that§4631(d) imposes burdens that are based on the content of speech and that are aimed at a particular viewpoint. The First Amendment requires heightened scrutiny whenever the government creates “a regulation of speech because of disagreement with the message it conveys.” A “consumer’s concern for the free flow of commercial speech often may be far keener than his concern for urgent political dialogue.” That reality has great relevance in the fields of medicine and public health, where information can save lives.”
“To sustain the targeted, content-based burden §4631(d) imposes on protected expression, the State must show at least that the statute directly advances a substantial governmental interest and that the measure is drawn to achieve that interest. There must be a “fit between the legislature’s ends and the means chosen to accomplish those ends.” As in other contexts, these standards ensure not only that the State’s interests are proportional to the resulting burdens placed on speech but also that the law does not seek to suppress a disfavored message.”
“The State cannot engage in content-based discrimination to advance its own side of a debate. The State gives possessors of the information broad discretion and wide latitude in disclosing the information, while at the same time restricting the information’s use by some speakers and for some purposes, even while the State itself can use the information to counter the speech it seeks to suppress. Privacy is a concept too integral to the person and a right too essential to freedom to allow its manipulation to support just those ideas the government prefers.”
“When it enacted §4631(d), the Vermont Legislature found that the “marketplace for ideas on medicine safety and effectiveness is frequently one-sided in that brand-name companies invest in expensive pharmaceutical marketing campaigns to doctors.” “The goals of marketing programs,” the legislature said, “are often in conflict with the goals of the state.” §1(3). The text of §4631(d), associated legislative findings, and the record developed in the District Court establish that Vermont enacted its law for this end. The State has burdened a form of protected expression that it found too persuasive. At the same time, the State has left unburdened those speakers whose messages are in accord with its own views. This the State cannot do.”
KENNEDY, J., delivered the opinion of the Court, in which ROBERTS, C. J., and SCALIA, THOMAS, ALITO, and SOTOMAYOR, JJ., joined. BREYER, J., filed a dissenting opinion, in which GINSBURG and KAGAN, JJ., joined.
The following SCOTUS Justices made the following public statements:
Chief Justice John G. Roberts, Jr.: “You want to lower your health care costs, not by direct regulation, but by restricting the flow of information to doctors…[the state is] censoring what they can hear to make sure they don’t have full information.” (3)
Justice Ruth Bader Ginsburg: The state is “interested in promoting the sale of generic drugs and correspondingly to reduce the sale of brand-name drugs, [but] you can’t lower the decibel level of one speaker so that another speaker, in this case the generics, can be heard better.”
(3)
REFERENCES
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