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Free speech at stake for IVDs
According to industry experts, IVD manufacturers could be drawn into an ongoing First Amendment battle with FDA if the agency's draft compliance policy guide (CPG) for RUOs and IUOs takes effect in its current form.
The draft CPG, "Commercialization of In Vitro Diagnostic Devices Labeled for Research Use Only or Investigational Use Only," would restrict the labeling claims that manufacturers could make for such products. For example, it would preclude manufacturers from making certain types of claims about performance characteristics, safety, or efficacy.
The limitations would apply even if the information is truthful and not misleading. The draft also says that product distribution could be suspended unless manufacturers comply.
In drafting the CPG, FDA sought to encourage manufacturers to file premarket submissions for new product uses and indications. The CPG therefore applies not only to package labels, but also to supplementary labeling provided by manufacturers. FDA's definition of the term labeling includes package inserts and spec sheets, as well as promotional reprints of peer-reviewed articles and book chapters and other materials.
In a recent letter to FDA, Jeffrey Gibbs, a partner in the law firm of Hyman, Phelps & McNamara (Washington, DC), expressed concern regarding the limitations that the draft CPG would impose on manufacturers. Citing several precedents, Gibbs pointed out that the CPG could fall under judicial scrutiny for suppression of truthful and nonmisleading information.
One case cited involved FDA guidelines restricting the dissemination of reference texts and journal articles to physicians and prohibiting manufacturers from sponsoring continuing medical education seminars. The court concluded that the FDA was unconstitutionally limiting commercial speech. The court stated that "conclusions reached by a laboratory, scientist, or university academic . . . are not 'untruthful' or 'inherently misleading' merely because the FDA has not yet had the opportunity to evaluate the claim."
Two other cases involved advertisement and promotion of pharmaceuticals and dietary supplements. In both cases, the courts invalidated FDA regulation of health claims as being unconstitutional restraints on speech. In all cases, the courts agreed that FDA expressed legitimate governmental concerns, but that the agency's restrictions did not directly address or advance those concerns.
Gibbs urged FDA to thoroughly evaluate its policies regarding research and investigational use only diagnostic products so that the final CPG will not infringe upon manufacturers' rights to provide truthful and nonmisleading information.
Supporting these positions, the Washington Legal Foundation (WLF) filed briefs in the ongoing WLF v. Henney case, arguing that the proposed FDA regulation is unconsitutional on First Amendment grounds. According to WLF attorney Richard Samp, the group's April brief, "restates earlier points, but by targeting section 401 of the FDA Modernization Act of 1997, we are opposing Congress as well as FDA." Section 401 specifically addresses the requirements for dissemination of information on treatments involving drugs or devices.
The current draft of the CPG for IVDs was made public in January 1998 and can be viewed on the Web site of FDA's Center for Devices and Radiological Health.
Meanwhile, in the WLF v. Henney case, FDA filed its final briefs this May, and the decision now rests with the court. Samp anticipates that a decision will be forthcoming before the end of the year.—Gary Woo
