CDER Free Speech Response Complicated By Family Ties
This article was originally published in RPM Report
Executive Summary
It’s hard enough for FDA to try to chart its course on promotional claims in the face of shifting opinions in the courts. Now, the CDER management team has to deal with a change in leadership of one of the key internal groups monitoring the issue.
As the Center for Drug Evaluation & Research tries different approaches to placate the courts on the parameters for commercial speech regulation, one of the key groups involved (the Office of Medical Policy) is undergoing an unexpected transition.
The recently appointed acting head of that office, Jonathan Jarow, was reassigned to the center director’s office effective Oct. 26.
In an email to CDER staff, Director Janet Woodcock said the reassignment was due to “conflict issues due to spousal employment.”
Woodcock praised Jarow’s work as head of Medical Policy for eight months. However, she noted his spouse’s employment means he “is not eligible to hold this position.” He will still be involved in policy implementation in his new role, but as part of Woodcock’s immediate staff, rather than as head of a separate office. Jarow “will serve as a senior medical advisor and implement projects and policy development on behalf of the Director and Director’s office,” FDA said.
Jarow’s departure means that OMP’s deputy director, Denise Hinton, will return to the post as acting director. Hinton previously served in that capacity for a year following the departure of the last permanent head of OMP, Rachel Sherman, at the end of 2013. (Sherman has now returned to FDA as a deputy to FDA commissioner-nominee Robert Califf).
Jarow, a former oncology reviewer, was originally named acting OMP head for a 120-day detail that amounted to a tryout for the position. When that period ended in June, it appeared that he would become the permanent director.
Woodcock credited Jarow with playing a “vital role in advancing the development and implementation of medical policy guidelines and initiatives related to antibacterial drug development, expanded access, patient and professional prescription drug labeling, First Amendment challenges, and prescription drug promotion.”
The promotion issues fall last on Woodcock’s enumeration of Jarow’s previous tasks but that is a major management function of the medical policy office in the wake of a recent unfavorable decision (Amarin) and at least one pending further challenge (Pacira). The head of the office oversees the regulation of prescription drug promotion and advertising through the Division of Drug Marketing, Advertising, and Communications.
CDER did not describe the conflict or identify his spouse’s position. Public records, however, indicate that he is married to Skadden Arps attorney Jennifer Bragg. Formerly with FDA’s office of the chief counsel for over five years from 1998-2003, Bragg was associate chief counsel for enforcement. Her Skadden profile says that the issues she worked on at FDA included “compounding pharmacies, unapproved pharmaceuticals, controlled substances, misbranded devices and food-related good manufacturing practices (GMP).”
The description of her client issues at Skadden is weighted more towards the medical device sector but there are situations described relating to pharmaceutical promotion. She advised one drug client on launch issues: providing regulatory guidance to “an international pharmaceutical manufacturer … in connection with the company’s preparations to launch a new drug in the United States.”
Recently, Bragg is listed as the second author behind John Bentivoglio in a Skadden analysis
of the Free Speech/promotion situation post-Amarin.
At several points that analysis demonstrates the awkward overlap between outside advice on the situation in flux and management responsibilities for FDA’s drug promotion oversight. The Skadden attorneys predict that drug companies are likely to initiate more challenges to FDA until the agency issues a guidance officially acknowledging its chastened authority.
The Skadden team projects “there will be a steady flow of litigation similar to Amarin and Pacira until FDA issues guidance to the industry that demonstrates a commitment not to engage in regulatory conduct or enforcement actions that necessarily or consequentially abridge the First Amendment rights of manufacturers. It is likely that FDA moved quickly, after the court’s ruling in Amarin, to try to settle the case to limit further damage; the filing of the Pacira litigation demonstrates that after failing to appeal Caronia, the government may have already lost the ability to limit Caronia’s reach.”
On the use of warning letters to enforce drug advertising control in the face of the Pacira challenge of that tactic, Skadden advises that FDA may well lose that tool soon.
“The potential exists for a substantial impact on how FDA uses its Warning Letters. FDA rarely has had to defend its power to issue Warning Letters or what it says as a regulator in those letters,” Skadden notes. “That power is under direct attack in Pacira in the same inhospitable forum that decided Amarin. A ruling by the Southern District of New York against FDA in Pacira likely would have a profound impact on the number and content of future Warning Letters.”
That kind of analysis, coming in part from a spouse to a key manager, it is not the type of added story that FDA needs while trying to find its way to new drug promotion rules.