FDA Revamps to Meet New Challenges - Added responsibilities and outside concerns prompt overhaul of agency's structure. - BioPharm International


FDA Revamps to Meet New Challenges
Added responsibilities and outside concerns prompt overhaul of agency's structure.

BioPharm International
Volume 24, Issue 12, pp. 12-15


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 therapies.

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.


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 http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/default.htm.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,

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