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Originally published November, 1998
REGULATIONS & STANDARDS
Free-speech decision could advance off-label IVD promotion
Jeffrey N. Gibbs
Over the years, very few constitutional challenges to FDA authority have been successful. But on July 30, Judge Royce Lamberth of the United States District Court for the District of Columbia struck down several important FDA policies on the ground that they violated the First Amendment.1 This decision may benefit IVD companies.
Historically, FDA has prohibited companies from distributing information about off-label uses of their products except in certain narrowly defined circumstances. FDA significantly restricted the dissemination of scientific articles that discuss off-label uses of approved drugs, biologics, and devices. The agency also developed policies curbing company-sponsored seminars at which off-label uses were discussed.2
The WLF Suit
In 1994, the Washington Legal Foundation (WLF; Washington, DC) filed a lawsuit challenging FDA's restrictions on the dissemination of information relating to off-label uses. WLF's principal allegation was that FDA's policies infringed upon the First Amendment's protection of free speech.
In response, FDA sought to have the case dismissed on procedural grounds. For example, FDA asserted that since the restrictions were merely statements of policy—as distinguished from rules—there was no final agency action reviewable by the court. The agency also argued that WLF did not have standing to bring the case because it was not directly affected by FDA's restrictions. Judge Lamberth rejected both of these arguments.3
Although most lawsuits involving FDA are decided without the plaintiff being permitted to depose any agency employees, the discovery phase of this case presented an exception. WLF was allowed to take depositions from several senior FDA officials, including William Hubbard, associate commissioner for policy coordination, and Byron Tart of the Center for Devices and Radiological Health. The court found some of the information gleaned during these depositions to be relevant to its decision.
The discovery process also resulted in an unprecedented ruling. Over FDA's objections, WLF was granted the right to depose then-commissioner David Kessler. FDA sought relief in the court of appeals, which was denied.4 If not for his subsequent resignation, Kessler would have faced the dilemma of whether to allow himself to be deposed or potentially be found in contempt for refusing to be deposed.
The July Decision
After all this procedural wrangling, both FDA and WLF filed motions for summary judgment. In its July 30 order, the court denied FDA's motion and granted WLF's.
The first issue that the court needed to address was whether FDA's policies regulated speech or conduct. This threshold issue was critical, because conduct is not entitled to the same level of constitutional protection as speech. The judge disposed of FDA's argument quickly, saying that "This court is hard pressed to believe that the agency is seriously contending that 'promotion' of an activity is conduct and not speech, or that 'promotion' is entitled to no First Amendment protection."5
FDA next argued that First Amendment protections did not apply because the agency has pervasive powers to regulate industry, in effect subsuming industry's First Amendment rights. The court disagreed, ruling that government's power to regulate many industry activities does not mean that it also has an untrammeled right to regulate speech.
However, the court agreed with FDA on the next point: that the distribution of reprints and sponsorship of scientific symposia constitute commercial speech. WLF had argued that these forms of communication are pure speech, which is entitled to a much higher level of constitutional protection than commercial speech. Governmental restraints on pure speech rarely survive judicial scrutiny.
In finding that these activities are commercial speech, the court used language that is likely to be cited by FDA in the future. Referring to the possible risks of enduring materials and company-sponsored seminars, the court wrote, "The potential to mislead, and the harm that could result, convinces this court that it is permissible to 'depart from the rigorous review that the First Amendment generally demands.' "6
Having decided that reprints and seminars constitute commercial speech, the court then applied the four-prong test established by the Supreme Court for reviewing the constitutionality of restrictions on commercial speech. First, the court found that the speech was neither unlawful nor inherently misleading. The agency had argued that until FDA has reviewed and approved a claim, it is inherently misleading. In a passage that is likely to be frequently quoted, Judge Lamberth wrote:
In asserting that any and all scientific claims about the safety, effectiveness, contraindication, side effects, and the like regarding prescription drugs are presumptively untruthful or misleading until the FDA has had the opportunity to evaluate them, FDA exaggerates its overall place in the universe. . . .[The] conclusions reached by a laboratory scientist or university academic and presented in a peer-reviewed journal or textbook, or the findings presented by a physician at a CME seminar, are not "untruthful" or "inherently misleading" merely because the FDA has not yet had the opportunity to evaluate the claim.7
Nevertheless, the district court also emphasized that its ruling does not restrict FDA's ability to control claims that actually are false or misleading. In determining what actions to take in light of the WLF case, companies will need to pay heed to this important limitation on the scope of the ruling.
Applying the second element of the Supreme Court's test, the court agreed that FDA has a substantial interest in regulating enduring materials and seminars, and in forcing manufacturers to obtain agency approval for off-label treatments. (Government regulation of commercial speech can be voided if such regulation does not advance a substantial interest.) But the court also said that FDA cannot justify its regulation by citing fears that such commercial information might be misused by physicians.
The court further agreed that FDA's policies advance this important interest. The court observed that FDA's restrictions on enduring materials and continuing medical education (CME) programs provide an incentive for manufacturers to get approval for off-label uses of their products.
While agreeing that FDA's restrictions advanced a substantial government interest, however, the court found that they flunked the fourth prong of the Supreme Court's test: they are more extensive than necessary. The court advanced several reasons for its conclusion. For instance, it noted that off-label treatments are often the most effective ones. "In this case, the truthful information may be life saving information, or information tha[t] makes a life with a debilitating condition more comfortable."8 The court also noted that even without these restrictions, companies have adequate incentives to get FDA approval for new uses.
More Wrangling
Even the court's July decision has not brought an end to the procedural wrangling over this suit. Since the decision was handed down, FDA has filed a motion to amend the judgment, basing its argument on the extensive provisions relating to the distribution of off-label reprints and textbooks in the FDA Modernization Act of 1997 (FDAMA).9 The provisions of FDAMA would allow such distribution, but only under circumscribed conditions and with FDA's prior approval. FDA has asked that the court's order be modified so that it would affect only the agency's guidance documents, and not FDAMA. WLF has opposed that motion, arguing that the court's First Amendment decision applies to all FDA restrictions on the dissemination of speech—including those in FDAMA.
FDA's motion is currently pending. If it is granted, FDA's current guidance documents on this subject will be void, but companies will be required to comply with FDAMA's restrictions on the distribution of reprints when that section goes into effect this November. CME programs, which are not mentioned in FDAMA, will be subject only to the court's order, and not to FDA's guidance documents. If the motion is denied, the court order issued on July 30 would presumably prohibit the agency from using FDAMA to restrict the distribution of reprints or textbooks relating to off-label uses.
In industry, there has been some misunderstanding of the meaning of the court's order. It certainly does not mean that companies can distribute any off-label information they want. However, under the order FDA cannot prohibit an IVD company from taking the following actions:
- Distributing reprints of articles that have appeared in a bona fide, peer-reviewed professional journal. FDA could interpret this provision as allowing it to restrict the distribution of special supplements devoted to a single product.
- Distributing textbooks published by a bona fide independent publisher; that is, a publisher that has no corporate affiliation with the manufacturer and is in the business of publishing and distributing books.
- Suggesting content or speakers for an independent program provider. A provider is independent if it has no connection with the sponsor, engages in the business of creating CME seminars, and is accredited by a national organization.
Significantly, the order explicitly allows FDA to take action to prevent the distribution of materials that are false or misleading. Moreover, FDA can require companies to disclose that the uses described in the article or discussed at the seminar have not been approved by the agency, and can compel the company to disclose its interest in the drugs or devices being discussed. IVD companies would be well advised to take these steps, even in the absence of an FDA requirement.
IVD Implications
Although the WLF case concerned both devices and drugs, the court's opinion does not specifically refer to IVDs. Nevertheless, IVD companies can benefit from the decision if they understand what that decision means to them.
Assuming that FDA's motion to amend the judgment is not granted, an injunction is in effect prohibiting FDA from taking enforcement action against informational activities that were previously prohibited. However, companies that decide to distribute reprints should read the court's order carefully, and comply with all of its limits. They should also be judicious in which articles they choose to distribute.
There are certainly numerous instances of IVDs with off-label uses for which a substantial literature exists. One example is the use of alpha-fetoprotein (AFP) testing as a marker for Down's syndrome. Although AFP is often used for this purpose, such a use has not been cleared by FDA. Nor has the widely used triple-marker screen been approved by FDA. Companies will be able to distribute reprints relating to these uses if they are within the scope of the court's order.
Similarly, prostate-specific antigen (PSA) assays are routinely used to screen for prostate cancer, even though they are not approved for that purpose. The court's ruling would potentially permit companies to distribute certain articles regarding this off-label use. Of course, this would not provide equal footing with an assay approved for screening; an approved product can be advertised for screening, while an unapproved assay cannot. Even so, the ruling opens up new opportunities to provide information about off-label uses.
FDA has also restricted the flow of information regarding research-use-only and investigational-use-only products.
The court's ruling does not directly address these categories of IVDs. Nevertheless, the WLF case raises potentially significant constitutional issues for FDA policies that restrict the advertising of these products.
Conclusion
The WLF lawsuit has already lasted four years, and it may stretch on even longer. FDA may well choose to appeal the court's decision. How any appeal will come out is anyone's guess. The court of appeals could affirm the decision, reverse it on the procedural grounds raised by FDA long ago, or reverse it on the merits of the case.
Ironically, perhaps FDA can take comfort from its recent loss in the tobacco case. That case illustrates that a district court victory in a high-profile FDA case doesn't always mean success in the court of appeals.
References
1. Washington Legal Foundation v. Friedman, Civ. No. 94CV01306 (U.S. District Court, District of Columbia [DDC], July 30, 1998).
2. Gibbs J, "Industry-Supported Educational Programs: FDA's Final Policy," Regulatory Affairs Focus, 3(3):22, 1998.
3. Washington Legal Foundation v. Friedman, 880 F. Supp. 26 (DDC, March 9, 1995).
4. Washington Legal Foundation v. Friedman, 100 F.3d 1015 (D. C. Cir., November 29, 1996).
5. Washington Legal Foundation v. Friedman, Civ. No. 94CV01306, p 16.
6. Washington Legal Foundation v. Friedman, Civ. No. 94CV01306, p 32.
7. Washington Legal Foundation v. Friedman, Civ. No. 94CV01306, p 36.
8. Washington Legal Foundation v. Friedman, Civ. No. 94CV01306, p 53.
9. Food and Drug Administration Modernization Act of 1997, Pub. L. 105–115, sec. 552.
Jeffrey N. Gibbs is a partner in the law firm of Hyman, Phelps & McNamara (Washington, DC).
