Background
In February 2014, FDA released a new draft guidance document entitled Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices.
The guidance is a revision of a 2009 draft guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. That guidance came under fire from life science companies, which argued that it restricted their ability to “promote the public health” by distributing scientific information informing the safe and effective use of their products.
Labeling, the manufacturers said, cannot be all-encompassing, and patients and healthcare providers must rely on outside sources of information. This was seen as especially pertinent, since healthcare providers may use products off-label, even as companies cannot promote those same uses.
Consumer health advocates, meanwhile, claimed the guidance would create an open loophole, which would allow companies to freely promote the off-label uses of their products.
FDA’s revised guidance was aimed at addressing some of industry’s and the public’s concerns by making clear that the pharmaceutical and medical device industries candistribute medical and scientific reprints to medical professionals, but only under certain conditions.
The Guidance, in Brief
For example, the information should not have been funded, either in whole or in part, by the company. This is presumably meant to prevent companies from sponsoring literature on an off-label use of a drug and then distributing that literature to increase prescribing.
Scientific and medical journal articles, for example, should be from a peer-reviewed journal, be distributed in unabridged form (i.e. reprint), contain information from an “adequate and well-controlled clinical investigation” and be “scientifically sound.”
In addition, the FDA-approved labeling should be disseminated along with the literature, as well as a comprehensive bibliography of information from other publications (including contradictory literature) and separate from any promotional literature.
WLF: Companies Have First Amendment Rights
But as the Washington Legal Foundation (WLF) argues in public comments filed on 16 May 2014, FDA’s guidance document is in direct violation of a 1998 permanent injunction (WLF v. Friedman) it obtained against the agency to prevent it from trampling on industry’s purported First Amendment rights. That injunction, WLF claims, “prohibits the agency from preventing manufacturers from disseminating peer-reviewed medical journal articles and medical texts that contain truthful off-label information,” limiting FDA’s ability to enforce what WLF calls “speech restrictions.” Failure to follow the injunction would cause FDA to be held in contempt of court, WLF wrote.
The comments are similar to ones filed by the group in 2008, which also claimed the agency’s guidance violated the same injunction. At the time, WLF argued that FDA needed to “substantially revise” the guidance to limit the number and type of restrictions placed on companies. And while FDA’s latest guidance does contain revisions, WLF said in its latest comments that it is “dismayed that the Draft Guidance makes no effort to correct any of those infirmities.” The effect of the guidance is to limit the First Amendment free speech rights of companies, WLF said—a “particularly glaring” omission given a slate of recent Supreme Court decisions upholding those rights.
The legal group recommended that FDA take the same actions it originally recommended in 2008:
1. Eliminate any reference to “adequate and well-controlled clinical investigation,” a reference that likely will be interpreted as imposing severe limitations on the types of journal articles that may be disseminated
2. Narrow the overly burdensome “disclaimer” requirements, such as that the article be accompanied by a comprehensive bibliography and articles/texts expressing contrary or different conclusions
3. Scale back on the limitations imposed on disseminating medical texts, particularly the distribution of individual chapters from a medical text
Without making these changes, companies will find it “virtually impossible” to distribute reprints, WLF contended. While “reasonable” restrictions are fine, WLF said, the sum total of FDA’s current restrictions—outlined in the guidance—are overly restrictive and de factoviolate industry’s First Amendment rights.
WLF’s complete comments may be found on its website, and soon on FDA’s public docket.
REFERENCE: Regulatory Focus; Alexander Gaffney, RAC; 16 MAY 2014