FDA Policy Vet Joins Generic Drug Advocacy Group

One of the leading trade associations advocating for the widespread availability of generic drugs and biosimilars has brought on a new deputy general counsel.

Rachel Sher has joined the Association for Accessible Medicines from the U.S. Food and Drug Administration, where she most recently served as senior policy analyst in the agency's Office of Policy.

A group spokesman did not immediately respond to a request for comment about the hire, including the scope of Sher's duties at the advocacy group, which was known until recently as the Generic Pharmaceutical Association. But Sher's experience in the federal government includes extensive legislative drafting.

In her policy position at the FDA, Sher was the agency's lead in the legislative process surrounding the 21st Century Cures Act, sweeping legislation passed late last year and strongly supported by the pharmaceutical industry that provides for investment in medical and mental health research and treatment and accelerates drug and medical device approval processes. In this capacity, Sher's policy discussions with congressional staff members focused on provisions of the law governing the generic drug and biosimilar industry, the AAM said in a statement.

"Ensuring the widespread availability of safe and effective generic drugs and biosimilars is one of the most important steps we can take in the face of today's spiraling health care costs," Sher said in the statement. "AAM plays a critical role in achieving this goal and I am thrilled to have the opportunity to join this team."

Sher will presumably report to Jeffrey Francer, who is senior vice president and GC at the AAM.

Before joining the FDA, Sher worked for 10 years for former U.S. Rep. Henry Waxman, D-California, as senior FDA counsel. There, she drafted and negotiated major FDA legislation, including the Biologics Price Competition and Innovation Act (enacted as part of the Affordable Care Act) and the Food Safety Modernization Act.

She worked as an assistant state attorney in Jacksonville, Florida, a trial attorney in the Office of the Attorney General for the District of Columbia and an associate at Hogan & Hartson (now Hogan Lovells) before taking the job with Waxman, according to her LinkedIn profile.

In addition to Sher's degree from the Levin College of Law at the University of Florida, she holds a master's of public health, with a health policy analysis emphasis, from the Milken Institute School of Public Health at The George Washington University.