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 email@example.com