In October of this year, Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) Director Tom Abrams announced that he was retiring from the agency after spending almost three decades working on the regulation of prescription drug advertising and promotion.
Abrams’ tenure “has been marked by his strong support for a vibrant program of social science research, generating data to show how messages are heard and understood, and by clearer guidance to industry about what is acceptable, prioritizing the most important issues,” said Jon Bigelow, Executive Director of the Coalition for Healthcare Communication. Bigelow also praised Abrams for building “OPDP into a steady, reasonable and predictable guardian to allow industry to effectively communicate with healthcare professionals and patients about innovative medicines.”
Abrams used research to respond to a changing promotional landscape. “At a time when the FDA is getting significant political criticism,” Bigelow continued, “Tom Abrams’ career is a reminder that the FDA leadership team and staff includes dedicated professionals working hard to improve regulation of pharmaceuticals.”
“Tom is the architect of today’s regulatory oversight of prescription drug marketing and communications,” said former FDA associate commissioner for public affairs and current APCO Worldwide Senior Director Wayne Pines, “He orchestrated the development of all the current guidances, enforcement policies and research. He achieved this in the most dynamic period in the history of pharmaceutical innovation and communications technology changes. Throughout, he guided his staff with a sure hand and an amicable manner, and established and maintained good relations with the regulated companies and their agencies.” Pines praised Abrams for building “a strong regulatory foundation.”
During his many years at the agency, Abrams was respected by his staff and by industry. “Tom has always been the consummate professional. He was courteous in every engagement, and I genuinely looked forward to seeing him and hearing from him every time I had that opportunity,” said Dale Cooke, president of PhillyCooke Consulting. “He also led DDMAC/OPDP through some very challenging times, as dramatic changes in the marketplace, law, and enforcement environment were rippling through the industry.”
Cooke also praised Abrams for always putting public health first, saying, “At every step (and even when I disagreed with him), I saw Tom as putting the interests of public health at the forefront. He sincerely appreciated the need for industry to get important information to the public and the need for industry to do so compliantly. The industry and the public owe him a debt of gratitude.”
Throughout his tenure with the agency, Mr. Abrams held multiple positions, including Acting Director, Acting Deputy Director, and Branch Chief in the division, which was formerly known as the Division of Drug Marketing, Advertising, and Communications (DDMAC). He began his career with the agency as a reviewer in DDMAC where he focused on reviewing promotional material for cardiovascular products. Prior to that, he worked for Merck and Company in pharmaceutical sales and marketing. Mr. Abrams has a BS in pharmacy from the School of Pharmacy at Rutgers University and an MBA from Rutgers School of Business.
OPDP Staff Director Catherine Gray will serve as OPDP acting director and is likely to be considered for the permanent Director position going forward.