Last week, the U.S. Court of Appeals for Second Circuit ruled that the Food and Drug Administration (FDA) cannot prosecute pharmaceutical manufacturers’ representatives for speech promoting the lawful, off-label use of an FDA-approved drug. The decision, United States v. Caronia, could dramatically expand the free-speech rights of pharmaceutical companies and compounding pharmacies alike. Compound marketers could enjoy greater leeway to share unapproved information.
The case involved a pharmaceutical marketing representative, Alfred Caronia, who was an employee of Jazz Pharmaceuticals. Jazz Pharmaceuticals manufactures Xyrem, a powerful central nervous system depressant used to treat narcolepsy patients who experience cataplexy (a condition associated with weak or paralyzed muscles) and excessive daytime sleepiness (EDS). The FDA recorded Caronia marketing the drug for off label uses. He stated to a physician that, in addition to cataplexy and EDS, Xyrem could be used to treat insomnia, Fibromyalgia, periodic leg movement, restless leg syndrome, MS, Parkinson’s disease and other sleep disorders. Caronia additionally marketed the drug to treat patients under the age of 16 (despite the fact that the Xyrem had only been approved by the FDA to treat patients over the age of 16).
Caronia was convicted of violating Sections 331(a) and 333(a)(1) of the Food, Drug and Cosmetic Act (FDCA). In those sections, the FDA prohibits the introduction of a misbranded drug into interstate commerce. He was sentenced to one year’s probation. Caronia appealed the conviction to the Second Circuit.
On appeal, the Second Circuit overturned the conviction. The appellate court found the government improperly punished Caronia for his speech. This form of restriction on speech violated the First Amendment to the Constitution. The Court noted that the FDCA defines misbranding in terms of whether a drug’s labeling is adequate for its intended use, and permits the government to prove intended use by reference to promotional statements made by drug manufacturers or their representatives. However, the Second Circuit declined the government’s invitation to construe the FDCA’s misbranding provisions to criminalize the simple promotion of a drug’s off-label use by pharmaceutical manufacturers and their representatives. Such a construction—and a conviction obtained under the government’s application of the FDCA—would run afoul of the First Amendment.
This decision will likely expand the permissible scope of marketing efforts of pharmaceutical manufacturers for off-label uses of FDA-approved drugs in the States within the Second Circuit (New York, Connecticut, Vermont). The extent to which this may afford greater leeway to compound prescription marketers is less clear. Much of the opinion dealt solely with the issue of promoting an off-label use for an already FDA-approved drug. Specifically, the Court noted that “[a]s off-label drug use itself is not prohibited, it does not follow that prohibiting the truthful promotion of off-label drug usage by a particular class of speakers would directly further the government’s goals of preserving the efficacy and integrity of the FDA’s drug approval process and reducing patient exposure to unsafe and ineffective drugs.” The same might not be said as to compound medications.
Moreover, the Court struck down the conviction because a prohibition on speech applicable only to pharmaceutical representatives as to off-label uses did not pass the test for regulation of commercial speech set forth in Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980). The Supreme Court in Central Hudson instituted a four-step analysis for regulation of commercial speech:
- Is the expression protected by the First Amendment? For speech to come within that provision, it must concern lawful activity and not be misleading
- Is the asserted governmental interest substantial?
- Does the regulation directly advance the governmental interest asserted?
- Is the regulation more extensive than is necessary to serve that interest?
Here, the Second Circuit noted that one of the goals to be served by the FDCA was regulation of branding and registration of new drugs, and that this goal would not be circumvented by allowing pharmaceutical manufacturers’ representatives to discuss off label uses of already approved drugs. Meanwhile, allowing for the promotion of compound prescriptions not approved by the FDA could lead to a circumvention of the FDCA’s new drug requirements, and therefore, could satisfy the third prong of Central Hudson, which allows for regulation of commercial speech in certain limited areas.
Nevertheless, many principles upon which the Second Circuit relies in overturning the conviction as to the pharmaceutical manufacturer’s representative could equally apply to the promotion of non-FDA approved compound medications. Specifically, the Court noted that “prohibiting off-label promotion by a pharmaceutical manufacturer while simultaneously allowing off-label use ‘paternalistically’ interferes with the ability of physicians and patients to receive potentially relevant treatment information; such barriers to information about off-label use could inhibit, to the public’s detriment, informed and intelligent treatment decisions.” Continuing this theme of supporting the physicians’ and patients’ choice and the importance of free flow of knowledge, the Court went on to state that “in the fields of medicine and public health, ‘where information can save lives,’ it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed.”
These same compelling arguments could be made with respect to the marketing and promotion of compound prescription formulas to physicians for use by their patients. However, this celebration is cut short and broad application is limited by the Court’s statement that its “conclusion is limited to FDA-approved drugs for which off-label use is not prohibited, and [it] do[es] not hold, of course, that the FDA cannot regulate the marketing of prescription drugs.”
In sum, the Second Circuit has taken a new, broader approach, with respect to how and under what circumstances pharmaceutical representatives can promote a drug product. Many of the reasons upon which the Court based its decision to allow the off-label marketing of FDA-approved drugs are also applicable to the marketing of compound prescriptions. The true lasting effect of this decision will not be seen until a decision is issued by the Supreme Court and until a case is decided involving compound marketers.
Frier Levitt drafts opinion letters to compounding pharmacy clients outlining the ability to market and advertise compound pharmacy services, and explaining the risks of the various options and recommending a marketing plan for the pharmacy. Frier Levitt also drafts contracts and agreements between compound pharmacies and marketers, and has developed Standard Operating Procedures to ensure compliance by the marketers with Federal and State laws and regulations, including those related to what representations a pharmacy or its representatives can and cannot make regarding the compound medications. Frier Levitt can provide these services for a flat fee.
If your pharmacy is interested in advertising and marketing compound prescriptions, contact Frier Levitt. We can help your pharmacy ensure compliance, save money and avoid future liability.
