Pinney Associates

Pinney Associates is a consultancy that works with pharmaceutical and consumer healthcare companies navigating regulatory and commercial environments. Founded in 1994, it introduced an evidence-based approach to helping companies foster employee health, and soon after was invited by SmithKlineBeecham to participate in switching nicotine replacement therapy from prescription-only to OTC status in the United States. The firm specializes in Rx-to-OTC switch and supporting marketed consumer healthcare products, providing strategic advice and tactical support to reduce regulatory risk, achieve regulatory approval, secure competitive claims, and enhance product reach and value. Its multidisciplinary teams include behavioral and clinical scientists, and its leaders include CEO Joe Gitchell, President Lucy Owen, Vice President Jack Henningfield, PhD, and Senior Scientific Advisors Judy Ashworth, MD, and Saul Shiffman, PhD.

Pinney Associates was founded in 1994, when it introduced an innovative, evidence-based approach to helping companies foster employee health. Soon after its founding, SmithKlineBeecham (SKB; which became GlaxoSmithKline Consumer Healthcare and is now Haleon) invited John Pinney to participate in a novel project: switching nicotine replacement therapy from prescription-only to OTC status in the United States. John Pinney's time in the military taught him the value of rigorous project management, and from his work within the Department of Health, Education, and Welfare and the U.S. Public Health Service, he understood how science can provide practical solutions to complex public health problems. In response to SKB's request for support, John assembled the core of the Pinney Associates team—scientists and academic experts united by a commitment to advancing individual and public health, and to finding innovative ways to assemble data that informs solutions to the challenges faced by pharmaceutical and consumer healthcare companies. During the years that Pinney Associates supported the successful switches of other NRT products, its numbers grew to include a distinguished cadre of behavioral and clinical scientists. The firm has been part of teams that worked to achieve FDA approval of over-the-counter Opill, the first oral contraceptive to be made available without a prescription in the US (approved July 13, 2023), and OTC RiVive, a naloxone nasal spray for the reversal of opioid overdose developed by the non-profit company Harm Reduction Therapeutics (approved July 28, 2023).

Leaders in Rx-to-OTC switch, deeply committed to championing switches with the potential to have a significant impact on individual and public health.

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