Arnold I. Friede, Sandler, Travis & Rosenberg, P.A..
Producers and users of prescription drugs have a shared interest in the communication of information about medications and the types of conditions they treat. According to the Food & Drug Administration (FDA), however, communications such as patient brochures should not include information about a specific medical condition and the attributes of an applicable drug treatment. Is such a limitation in the best interests of public health?
FDA has taken this position twice in the past two years, first in the fall of 2008 and again this past June. In September 2008, FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) sent compliance correspondence to five manufacturers of attention deficit hyperactivity disorder (ADHD) drugs. As discussed in a Washington Legal Foundation Legal Backgrounder I co-authored, DDMAC laid out a remarkable new interpretation about the consequences of including both disease awareness information and affirmative product claims in the same promotional piece, whether or not proximate to each other.
FDA’s speech regulators concluded, in effect, that whenever a manufacturer provides information about the consequences of ADHD generally, and then makes affirmative product attribute claims, no matter what their physical or contextual nexus, the two together will necessarily be construed as impliedly representing that the advertised product is effective in addressing these outcomes. DDMAC took this action based on its own unilateral understanding of each of the challenged pieces and without any empirical evidence whatsoever about what the target audience believed. Such “implied outcome claims” could only be made, DDMAC concluded, if supported by “substantial evidence,” i.e., evidence that meets the statutory substantial evidence standard for drug approval under §505(d) of the Federal Food, Drug, and Cosmetic Act.
In a June 10, 2010 Notice of Violation (NOV) to Auxilium Pharmaceuticals, Inc. about Xiaflex, DDMAC again asserted this nexus theory, albeit using a slightly different legal and regulatory rubric to characterize it. DDMAC challenged, among other things, the inclusion of general information about the condition the drug is intended to treat — Dupuytren’s disease — on the first full-page of text of a patient brochure that also discussed specific treatment options, including use of the promoted product, beginning on the second full-page of text. In a section of the first full-page of text, titled “Dupuytren’s Disease Overview,” Auxillium discussed this generally progressive condition and its increasing impact over time on a patient’s use of her hand. This Overview also discussed the progression of the disease from its early stage where lumps (or nodules) and dimples may appear in the palm to the later stages where “rope-like cords” may appear under the skin of the palm.
On the second full-page of the brochure, where the use of Xiaflex was specifically discussed for the first time in detail, Auxillum stated, under the heading “Nonsurgical Treatment,” that “Xiaflex is the only FDA-approved non-surgical treatment for adults with Duputyren’s contracture with a cord that can be felt. Xiaflex is injected directly into a Dupuytren’s cord, where it breaks down the cord’s collagen” (Emphasis supplied). These express references to use of Xiaflex only when “a cord can be felt,” to its injection directly into the Dupuytren’s “cord,” and to its action in breaking down collagen in “the cord,” all link directly to its FDA-approved product labeling. This says that “Xiaflex is indicated for the treatment of adult patients with Dupuytren’s contracture with a palbable cord.” (Emphasis supplied) What could be clearer? Not so fast.
Reading the brochure in an unsupported manner analogous to how it read the claims in the case of the ADHD drugs, DDMAC again unilaterally asserted that the combination of the disease awareness information on first full-page of text with the product attribute claims on the second full-page implies that Xiaflex is intended to treat all cases of Dupuytren’s contracture and not merely those with a palpable chord. FDA held that this “broadened the indication” for Xiaflex beyond the approved indication for the drug and hence violated the law. Of course, another, perhaps more malignant way of characterizing FDA’s accusation is that the company promoted the product for “off-label” use for all cases of Dupuytren’s disease and not just those where the cord is palpable. The broader implications of such allegedly “off-label” promotional activity put the consequences of FDA’s reading of the material into more stark focus.
So here is the manufacturer’s dilemma: Tell the patient about the disease and its evolution at the same time you are telling them about the product, and risk FDA enforcement action for “broadening the indication”/“off-label promotion” (or, in the case of the ADHD drugs, making implied outcomes claims that are not supported by substantial evidence). Or, omit any information about the disease itself and thereby fail to educate the patient about the condition the product treats, and just sell your product. Damned if you do; damned if you don’t.
The expansive use of this implied claims theory in the context of information that seeks to educate patients about a specific disease and then advise them about the attributes of the promoted product will likely have a perverse public health effect. Instead of encouraging dissemination of disease awareness information, which seems to be an important public health objective, FDA’s approach will likely result in the disaggregation of education from product promotion, which seems like odd, or at least questionable, public policy.