FDA Gets a New Look - Pharmaceutical Executive


FDA Gets a New Look

Pharmaceutical Executive

Spielberg Up Front

Particularly important to pharma, a new deputy commissioner for medical products and tobacco, Stephen Spielberg, was brought in to coordinate the activities of FDA centers for drugs, biologics, medical devices, and tobacco products. Spielberg also oversees a cluster of programs that affect multiple products, including orphan drugs, pediatric therapeutics, combination products, and clinical research practices.

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 FDA's Science Board. Most recently, he headed up a new Center for Personalized Medicine and Therapeutic Innovation at Children's Mercy Hospital in Kansas City, Mo. While in industry, he chaired a Pharmaceutical Research and Manufacturers of America (PhRMA) pediatric task force and was instrumental in promoting the Best Pharmaceuticals for Children Act, 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. Industry and FDA have agreed on a new five-year PDUFA program, but the trick will be to head off adding extra measures to the PDUFA bill, and to avoid embroilment in election-year politics that could delay enactment past September 2012.

Another challenge for Spielberg is to resolve disagreements between the medical device industry and the Center for Devices and Radiological Health (CDRH) over proposals to revise the device approval process. High-profile safety issues and recalls prompted FDA to re-evaluate its testing requirements for devices, with public meetings and a report from the Institute of Medicine. CDRH has proposed policy changes that expand clinical testing for some devices, and manufacturers are protesting that this will curb innovation. Industry wants Congress to step in and limit FDA requirements, an issue that will play out in coming months as device user fees are deliberated on Capitol Hill.

"Super" Changes at CDER

Parallel to the restructuring of FDA's top management, CDER director Janet Woodcock has engineered operational changes, with more "super offices" better able to manage CDER's expanding and diverse operations. CDER already had several super offices—for new drugs, pharmaceutical science, and translational sciences. Earlier this year, Woodcock added the Office of Surveillance & Epidemiology (OSE) to the super office list—a move designed to emphasize the importance of drug safety programs, such as adverse event reporting, observational studies, medical error prevention, and risk management. OSE's elevation also may quiet those who want to shift drug safety out of CDER and into an independent entity.

Next, CDER's Office of Compliance became another super office, with multiple divisions to manage field inspections and ensure compliance with regulatory standards. One new suboffice handles drug recalls, counterfeiting, diversion, and other supply chain issues. And the Office of Scientific Investigations monitors pharmacovigilance and Risk Evaluation and Management Strategies (REMS), in addition to the conduct of clinical trials.

More recently, CDER's Office of Medical Policy (OMP) also gained "super" status, a change that transforms the Division of Drug Marketing, Advertising & Communications into the Office of Prescription Drug Promotion. OPDP director Tom Abrams gained more managers and operating divisions to better regulate always-controversial drug promotional activities. Another OMP office has a number of high-profile assignments: implement FDA's Sentinel Initiative; oversee the Clinical Trials Transformation Initiative; and advance the Patient Medication Information initiative, which aims to develop a one-page patient information sheet to replace various inserts and handouts.

Woodcock said she seeks "a high-functioning, policy-driven, risk-based organization," in unveiling the new compliance office. Such an achievement would support innovative and effective drug development. FDA proudly announced last month that CDER and FDA's biologics center together approved 35 new molecular entities in fiscal year 2011 (ended Sept. 30), including a number of new cancer treatments and two drug-diagnostic combinations. The agency is most pleased that 24 of the 35 approvals occurred first in the US, and that most reviews required only one cycle.

Woodcock pointed to the apparent "speed and efficiency" of the drug approval process as evidence that FDA is not blocking new products from market, and that industry statements to that effect are "inaccurate and unfair." Instead, she said, FDA is using "creative approaches" and "exercising its regulatory flexibility" to expedite approvals, and more ideas for enhancing reviews are in the works.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at


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