Find your way confidently through the uncertain landscapes that confront pharmaceutical and consumer healthcare companies, with Pinney Associates by your side.
As leaders in Rx-to-OTC switch who are deeply committed to championing switches which have the potential to have a significant impact on individual and public health, we are honored to have been a part of the teams who worked tirelessly 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).
Get to know our leaders
“We work closely with our clients to understand their challenges and determine the best solutions for their specific projects.”
Judy Ashworth, MD
Senior Vice President
Senior Vice President
“Our clients succeed when they anticipate, and then carefully and thoroughly address, all of the challenges they face—as early in the process as possible.”
Lucy Owen
President
President
“We hold ourselves to the highest standards of excellence in science—guided drug development and regulation to achieve FDA approval with the most appropriate labeling.”
Jack Henningfield, PhD
Vice President, Research, Health Policy, and Abuse Liability
Vice President, Research, Health Policy, and Abuse Liability
“We provide thoughtful counsel to help our clients make sound regulatory, policy, and business decisions.”
Joe Gitchell
CEO
CEO
“Well-designed behavioral research can resolve key regulatory questions.”
Saul Shiffman, PhD
Senior Scientific Advisor, Behavioral Science, Study Design, and Analysis
Senior Scientific Advisor, Behavioral Science, Study Design, and Analysis
Explore our practice areas
Prescription Medicines
Specializing in the development of CNS-active drugs, from traditional pharmaceuticals to psychedelics and cannabinoids
OTC Products
Focusing on Rx-to-OTC switch and support of marketed consumer healthcare brands
Dietary Ingredients & Supplements
Mapping science-based regulatory pathways for dietary ingredients and supplements
Tobacco Harm Reduction
Advancing research and policies that minimize death and disease associated with smoking conventional cigarettes
Get to know our Data Analysis team
We specialize in using data analysis to generate new insights and perspectives, and to answer regulatory and policy questions.