The U.S. Food and Drug Administration (FDA) enjoys broad regulatory authority to police the approved-products market to protect public health. This authority is backed by an array of civil and criminal penalties FDA can impose to deter manufacturers from promoting products for intended uses outside of those which FDA has previously approved. This practice is commonly known as “off-label” promotion.
More recently, however, FDA’s regulatory authority has encountered challenges in the federal courts, which have begun to question the FDA’s ability to prohibit truthful and non-misleading claims in marketing. Commercial speech, which includes approved-product promotion, enjoys narrower protections than artistic expression or political or religious speech. Nonetheless, truthful and non-misleading speech in aid of marketing a product is generally protected under the First Amendment. An evolving body of case law thus indicates that a manufacturer’s promotion of a product for a lawful off-label use constitutes protected commercial speech under the First Amendment.
The question is where does the tipping point lie between protected First Amendment speech and prohibited conduct in the approved-products marketplace? This article first explores the tension between FDA’s broad regulatory mandate and the First Amendment, and how that tension is presently being resolved by the courts. Next, it offers some considerations that manufacturers may find helpful in more fully understanding their options when promoting an approved drug or device.
Can You or Can’t You?
It may come as a surprise that federal law does not expressly define or even ban off-label product promotion. Instead, FDA’s regulatory authority to prohibit off-label promotion arises from the federal Food, Drug, and Cosmetic Act (FDCA) and its preclusion of any adulterated or misbranded drug or device in interstate commerce. This prohibition includes the promotion of any product for an intended use outside of what the FDA has already approved for a product. From this murky framework, FDA has established its broad authority to generally prohibit any off-label promotional claims by a drug or device manufacturer. This prohibition does not extend to physicians in prescribing off-label product uses for their patients or publishing research concerning potential off-label uses.
But, while the FDA’s authority regulating drug promotional claims is broad, it is not limitless. Applying the First Amendment’s protections for commercial free speech, the U.S. Supreme Court has held that truthful and non-misleading speech in aid of pharmaceutical marketing is a form of commercial expression protected under the First Amendment. Accordingly, the FDA cannot prohibit a manufacturer’s truthful and non-misleading speech in isolation. Rather, the FDA must pair a manufacturer’s promotional claims regarding a product with other conduct violative of the FDCA to show the manufacturer’s objective intent to cause the use of a product outside its approved label or indication. As can be imagined, this analysis can be subtle.
Accordingly, the courts have generally upheld criminal convictions when, for example, a manufacturer has promoted an off-label use for a product for which the manufacturer filed no application or amendment with the FDA. Conversely, the courts have overturned criminal convictions when the off-label promotion was made to a target physician regarding an off-label use that the physician was otherwise entitled to learn from the applicable medical or scientific literature and thereafter prescribe.
The zone of what may be permissible for truthful and non-misleading off-label promotion is grey. There is, however, a strong consensus that any exception to FDA’s regulatory authority is narrow and must be read within the larger context of FDA’s mandate to safeguard public health.
FDA’s 2009 Guidance and 2014 Draft Guidance
In view of evolving case law and legal standards, the FDA has offered guidance to manufacturers to assist them in determining whether off-label promotion may be less likely to receive adverse regulatory scrutiny. The FDA has promulgated two publications on the topic: FDA’s 2009 “Guidance for Industry: Good Reprint Practices for the Distribution for Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices”; and FDA’s 2014 “draft Guidance: Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices.”
While the 2009 Guidance is still technically in effect, the 2014 draft guidance offers significant nuance in ascertaining the FDA’s latest thinking and enforcement priorities. Following the 2009 Guidance and 2014 draft Guidance is no assurance against a subsequent enforcement action by the FDA. But, FDA has stated that it does not intend to use a manufacturer’s distribution of scientific or medical information pursuant to the 2009 Guidance and 2014 draft Guidance as evidence of that manufacturer’s intention to cause the use of a product for an unapproved new use.
While manufacturers should always be careful regarding off-label promotion, the FDA has outlined a series of factors that are helpful when a manufacturer learns of a scientific or medical journal article, reference publication, or clinical practice guide that considers unapproved new uses for a product. The 2014 draft Guidance draws a clear distinction between scientific or medical journal articles on one hand and reference texts and clinical practice guides on the other. This approach constitutes an improvement over the 2009 Guidance while still nesting within the 2009 Guidance’s larger protections.
Regardless of the type of information they contain, the article, reference publication, or clinical practice guide should include the following indicia of trustworthiness (although this list is far from complete):
- Independence and peer-reviewed;
- Avoidance of conflicts of interest and biases among contributors, authors, and editors (including financial incentives made available by drug manufacturers);
- Expertise in the subject matter discussed; and
- Other indicia that point to the quality of the underlying study or subject matter and dependability of the results discussed and promoted.
In addition to being reprinted in full, the article, reference publication, or clinical practice guide (the last two of which may be reproduced in discrete chapters or parts) must be accompanied by a permanently affixed and prominently displayed statement disclosing a list of critical information. This information generally includes the product in which the manufacturer has an interest, that some or all the uses discussed may not have been FDA-approved, and all significant safety risks or concerns associated with the unapproved use known to the manufacturer but not discussed in the article.
There are a multiplicity of additional rules and considerations in deciding to promote a product within the framework outlined in the 2009 Guidance and 2014 draft Guidance. An experienced attorney is important to the larger marketing effort in providing information and guidance which the business can apply to help avoid needless and costly errors and improve the overall market approach.
Good and Experienced Counsel is Important
FDA’s 2009 Guidance and 2014 draft Guidance offer manufacturers a narrow but important window to inform target physicians and medical professionals about new off-label uses of their products. Nevertheless, the rules that manufacturers must follow to avail themselves of this narrow window are extensive and differ depending on the types of information the manufacturer would like to share.
Baker Jenner LLLP has counsel experienced in assisting manufacturers and others in obtaining their business, product, marketing, and compliance objectives within a complex regulatory environment (and through the lens of the FDCA). What our team can provide is thoughtful and practical legal representation. Schedule an initial consultation for a conversation with your legal partners and advisors, and stay tuned next month for a look at how firms can respectfully police the competition.
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