Off-Label Use and the First Amendment: The Pathway to Naivety?

Daniel E. Troy, recently appointed General Counsel for GlaxoSmithKline and Former Chief Counsel for the FDA, has recently authored a letter to the editor in the New England Journal of Medicine entitled “Pharmaceutical Promotion and First Amendment Rights.”

Mr. Troy attempts to offer justification in favor of off-label promotion of medications by manufacturers in scientific articles on the basis that the Constitution via the U.S. Supreme Court “affords truthful, nonmisleading commercial communication such as that embodied in reprints of scientific articles discussing off-label uses.”

Mr. Troy’s proposed constitutional relationship between the questionable practice of off-label promotion of medications, to the First Amendment, is extremely tenuous, especially where historically, off-label practice is and has been the primary source of many misgivings by the industry.

As Aaron S. Kesselheim, M.D. and Jeffery Avorn, M.D have so aptly replied, “there are important public health reasons for regulating the ability of companies to promote off-label uses of drugs for which the data have not been reviewed by the FDA. Manufacturers’ communications to physicians exist to increase product sales and heavily shape the choice of prescribers. Commercial distortions of the medical literature are well-documented, including omission and or underemphasis of safety data, presentation of negative or questionable findings about efficacy as being positive, selection of publication results, and industry-sponsored ghost-writing of seemingly academic papers. (emphasis added).

Still, many proponents in Mr. Troy’s camp are jumping at the opportunity to put forward the off-label First Amendment argument through the Courts, similar to Preemption.

More discussion to come.