The Formulary Fix Buries Fritz & Harvey: Drug Promotion Escapes Its Past Constraints

By O'Reilly, James T. | Washington and Lee Law Review, Winter 2018 | Go to article overview

The Formulary Fix Buries Fritz & Harvey: Drug Promotion Escapes Its Past Constraints


O'Reilly, James T., Washington and Lee Law Review


I. Setting the Scene

The young in-house lawyer, a recent W&L Law graduate, enters the meeting on the executive floor of corporate headquarters and observes the vigorous debate among the team of pharmaceutical marketing experts. One group wants to ask senior management to invest $7 million to conduct an additional clinical trial at three prestigious hospitals, in order to request that the FDA would allow the company to make the newly expanded claim that their ten-year-old acne drug "Alepsima" will cure hangnail.

This is the correct "by the book" route1 to selling a greater volume of Alepsima, at a greater profit, beginning in an estimated twenty-six months following submission of test results to the Food and Drug Administration (FDA). They expect that a label change will be approved, after the FDA allows the hangnail claim following a detailed medical evaluation of the clinical trial results, and after the FDA's team of reviewers of the company's supplemental new drug application feel they have seen enough supporting data, so that their approval of this drug for hangnail will be unassailable.

Another expert group of company marketers wants to push more Alepsima sales today, by overtly promoting its use against hangnails in trade-show booth presentations and sales visits to dermatologists and podiatrists, without awaiting FDA blessings. This group cites an in-house dermatology research team that conducted a less formal review of the technical literature, and found sixteen doctors whose hangnail patients had responded well to their use of Alepsima. The first group replies, "No! Such aggressive claims will get us into trouble."

At the head of the table, the division Vice-President turns to the young lawyer and says: "How much trouble will we be in, if we use the hangnail claim in sales presentations to sell Alepsima to doctors tomorrow?"

Hundreds of miles away, the maker of Hangtough® ointment has its sales team wondering what defensive moves will be needed, in response to rumors that Alepsima might intrude upon Hangtough's FDA-approved use as the best-selling brand for hangnails. Is litigating the right strategy? Will the FDA respond to our pleas, and defend us? How much is our lost market share potentially worth?

And, a thousand miles away, the Regional Drug Compliance Director of the FDA is oblivious to both, bemoaning yet another budget cut from the Trump Administration, which reduces the FDA's ability to monitor claims on drug labels for the latest gene-derived cancer drugs. If she had been asked she would probably respond: "Hangnail? Who cares? When we have death risks surrounding neonatal stem cell infusion, why spend the scarce resources we have on these less impactful decisions?"

So, the conflicts of Lanham Act2 remedy, the long shot of FDA and Justice Department cooperation to halt misbranding, and the potential for jeopardizing an income stream of millions to win marginal additional sales in the thousands, makes the young lawyer hesitate. If she or he is as bright as Chris Hurley, there will be a brilliant answer. Charles Dickens would see me as the Ghost of Christmas Past, and Chris as the smiling angel of the pharmaceutical industry's future. What the Dickens should come from this scenario today?

II. Yesterday's Blues

Fritz Lanham of Texas3 and Harvey Wiley of Indiana4 never met, but their respective legacies in legislation have given the federal courts numerous challenges to decipher. Fritz intended to update the federal trademark laws in the boom years of postwar commerce after World War II; the less busy federal courts had the time and the intellectual power to help Fritz create the legal protection of the statutory rights of trademark owners.

Harvey wanted to stop snake-oil salesmen who hawked their claimed curative potions with loud promises but an absence of supporting data and safety research.5 If Harvey and Fritz had met, chances are they would not have regarded the complexities of the 2018-era presentation of drug benefit claims6 as a theme for new legislative attention. …

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