SPIELBERG UP FRONT
The challenge for Spielberg, a leading pediatrician and pharmacologist, is to coordinate responses to these issues. His elevated
position makes him a ready spokesman for FDA medical-product regulators and gives him authority to make timely policy decisions
that otherwise would wait for Hamburg to weigh in. He also will facilitate the development of products that involve multiple
agency centers, including combination products, orphan drugs, and pediatric therapies.
Spielberg comes to FDA with 30 years experience in academia and industry. He has served on FDA advisory committees and got
to know Hamburg as a member of the advisory Science Board. Before coming to FDA, Spielberg was director of the Center for
Personalized Medicine and Therapeutic Innovation at Children's Mercy Hospital in Kansas City, Missouri. Previously, he was
dean of Dartmouth Medical School, and prior to that, he held senior research positions at Johnson & Johnson and Merck. While
in industry, he chaired a Pharmaceutical Research and Manufacturers of America pediatric task force and was instrumental in
promoting the Best Pharmaceuticals for Children Act, which was enacted in 2002 to provide incentives for developing pediatric
An initial task for Spielberg is to orchestrate reauthorization of the Prescription Drug User Fee Act (PDUFA), along with
new fees for generic drugs and biosimilars, by September 2012. Although industry and FDA generally agree on a new five-year
PDUFA program, they fear that the legislators will add numerous pet policies to this must-pass legislation.
A related challenge for Spielberg is to help resolve serious disagreements between the medical-device industry and the Center
for Devices and Radiological Health (CDRH) over proposals to revise the device-approval process. Safety issues and notable
product recalls have prompted efforts to stiffen FDA regulatory and testing requirements, particularly for those products
approved under the 510k regulatory procedure. After a lengthy evaluation process, which included public meetings and an IOM
report, CDRH officials have proposed changes likely to require additional clinical testing of some devices. Manufacturers
are protesting vehemently and urging Congress to support innovation by blocking such action.
"SUPER" CHANGES AT CDER
Parallel to the restructuring of FDA's top management, CDER Director Janet Woodcock has engineered operational changes that
also seek to deal with globalization and overcome obstacles to new drug development. Growth in responsibilities and in staff
has prompted the elevation of nearly all of CDER's main operating units into "super offices" with broader management structures
better able to monitor diverse operations.
In May 2011, Woodcock added the Office of Surveillance and Epidemiology (OSE) to the super-office list, joining the Office
of New Drugs, Office of Pharmaceutical Science, and Office of Translational Sciences. OSE Director Gerald Dal Pan gained more
support staff for his immediate office, plus for two subordinate offices: the Office of Medication Error Prevention and Risk
Management and the Office of Pharmacovigilance and Epidemiology. The various divisions of these larger operators manage CDER's
adverse-event reporting system, oversee sponsors' observational studies, prevent medical errors caused by product names, and
orchestrate risk-management programs. The move aims to highlight the importance of drug-safety issues and hopefully quiet
those who want to shift drug safety out of CDER and into an independent entity.
Next, Woodcock unveiled a new structure for CDER's Office of Compliance, making it another super office with multiple suboffices
and divisions. Ilisa Bernstein has been OC acting director since Autor left last summer. While many OC functions remain fairly
constant, a new Office of Drug Security, Integrity & Recalls was created to address the challenges of globalization and growing
drug counterfeiting and diversion (see the August 2011 Regulatory Beat column, "FDA Maps Strategy to Counter Supply-Chain
Threats"). The Office of Manufacturing and Product Quality oversees field inspections and compliance with GMPs. An increasingly
visible function is to prevent and mitigate drug shortages related to manufacturing and compliance issues. A larger Office
of Scientific Investigations now monitors pharmacovigilance and REMS programs, in addition to the conduct of clinical trials
and human subject protection.
More recently, CDER's Office of Medical Policy (OMP) also became a super office. Led by Rachel Sherman, OMP consists of the
Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications) and the
new Office of Medical Policy Initiatives. This last entity will oversee FDA's Sentinel Initiative for modernizing drug surveillance
and adverse event detection; the Clinical Trials Transformation Initiative to modernize trial conduct and oversight; and the
Patient Medication Information project which seeks to update FDA policies for communicating risk information to the public.
A key task is to support health reform initiatives related to biosimilars and other policy issues.
All the new acronyms are confusing, and critics are skeptical about so many "super" offices within CDER. Woodcock sees these
changes as leading to "a high-functioning, policy-driven, risk-based organization" that can "evolve and grow." And with any
luck, CDER's new management structure will provide more time for Woodcock to examine drug regulatory operations more broadly
and explain its actions and policies to its many constituents.
Organizational charts of the Center for Biologics Evaluation and Research can be found on the FDA website at
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, email@example.com