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Drug Law: Off-Label Use – A Paradigm Shift And A Moral Imperative

On December 16, 2016, the State Bar of Texas will host a Webcast on the FDA and Off-Label Uses of Medical Products.

Coincidentally in the wake of the 2016 presidential election, the Food and Drug Administration (FDA) is reevaluating its rules on how drug and device companies disseminate information. The change that the FDA is about to undertake is contentious, with each side dug in as deeply as the political parties were in the election. Unlike the election, however, a small still voice broke through the rancor and dissention.

The FDA has been grappling for more than fifteen years with a determined group of companies and individuals who champion the dissemination of more – not less – accurate scientific and medical information. These challengers question the FDA's restricting and criminalizing the distribution of such information. In response, the FDA stands behind the old paradigm of vague and restrictive rules and draft guidelines which punish manufacturers for the dissemination of information to physicians and the public about unapproved uses for its products. The FDA and those who support the FDA's position believe that a pernicious pharmaceutical and medical device industry will visit great harm on the public by providing information regarding products approved for one use and promoted for another. While this is a serious concern, the unintended harm from the FDA's current approach demands action – not words, more hearings or delay. (For more detail on these issues see our prior posts here and here).

The new paradigm has an unlikely champion. It is not a scientist, professor, judge, lawyer or politician. The voice that cut through the clamor did not spout arcane principles rooted in the labyrinth of rules and regulations that govern the marketing of medical products in the United States. The champion of the new was among the quietest voices of all.

Congress has left the FDA the hard work of navigating due process, the First Amendment and court deference to agency determinations. The FDA is ill-suited to this task, particularly in the current politico-jurisprudential climate where some of the judicial underpinnings for FDA authority are in question. The FDA did not hold two days of hearings on off-label use willingly; Congress and a menacing avalanche of adverse court rulings rejecting FDA's longstanding approach forced the FDA to conduct the hearing. Through all the bitterness surrounding FDA regulation of the release of medical and scientific information, on November 9 and 10, 2016, the FDA listened. By all accounts this was not a perfunctory hearing where the FDA just pretended to listen. Not unlike in the Old Testament story where Elijah is on Mount Carmel, the winds blew, the earth shook and fires raged. Many of the usual acrimonious voices that have forged the current impenetrable divide bombarded the FDA. At this hearing, however, some small voices managed to prevail.

One doctor testified at the hearing that the practice of medicine is an art. As we wrangle over how the FDA might fashion new rules governing how best for manufacturers to share what they know about their products, we might think of an artist poised to paint hope in the picture of a child sent home to die. The artist's palette contains tubes simply labeled "color" because the manufacturer cannot give him more information. Physicians with patients for whom the stakes are high and the options limited want better scientific and medical information about the contents of the tubes so they can paint some hope before sending a child home. The small still voice whispered in a thousand mothers' ears yesterday, thousands today and many more tomorrow. It is the voice of a child with cancer speaking through her mother telling us that for the third time she has been sent home to die.

Join us on December 16, 2016 at 10:00 AM for the State Bar of Texas Webcast entitled:

FDA Law: Off-Label Use of Drugs and Medical Devices – the election, the Supreme Court and the FDA. Due Process, Deference and the First Amendment; where we are and where we are heading. [Click here to register.]

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Walsh Michael web
About the author Michael A. Walsh Shareholder, Dallas, TX

Mike devotes much of his practice to counseling clients in regulated industry on issues related to manufacturing, labeling, compliance and transportation. He has extensive experience defending clients in complex administrative law and litigation matters, and has served as national coordinating counsel, regional trial counsel and as local Texas counsel in environmental and toxic tort litigation. Mike has practiced in Dallas since 1994. Prior to 1994, he practiced in New York City as a trial lawyer handling a broad range of matters including securities, commercial, real estate, intellectual property, pharmaceutical, toxic tort and environmental contamination matters. He is the author of the law book, The Supply and Distribution of FDA Regulated Products published by Thompson Reuters. Mike is a frequent writer and speaker on issues related to compliance and litigation for regulated industry and is regularly published on issues concerning toxic exposure, compliance and marketing. Mike is the founder of a daylong educational program designed for lawyers and senior industry executives in industry regulated by the federal Food and Drug Administration.

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