REGULATORY CHANGES
The potential impact of quality manufacturing systems on innovation and drug access provides a strong platform for change
in quality regulation, says Woodcock. CDER's pharmaceutical quality initiatives have yielded many successes, as seen in expanded
online monitoring of production lines; development of software and other technology to monitor manufacturing processes and
detect errors; harmonization of quality risk-management concepts through the International Conference on Harmonization; and
implementation of QbD approaches at many companies.
FDA has been less productive with efforts to provide industry with relief on manufacturing supplements and to build a pharmaceutical
inspectorate with greater expertise for evaluating innovative quality production systems. Woodcock is hopeful that added resources
provided by the Generic Drug User Fee Act (GDUFA) will revive the inspectorate program and provide more parity between foreign
and domestic site visits.
CDER also is responding to these developments by establishing an Office of Pharmaceutical Quality (OPQ), another "super office"
that will coordinate the review of chemistry, manufacture, and controls (CMC) data in applications with compliance efforts
to ensure adherence to good GMPs at plant sites. OPQ will replace the Office of Pharmaceutical Science (OPS), whose long-time
director, Helen Winkle, is retiring from the agency.
This change will bring together all CMC reviewers for generic drugs, conventional drugs, and biologics. In addition, the Office
of Manufacturing and Product Quality (OMPQ) in CDER's Office of Compliance will join the new entity. Meanwhile, the Office
of Generic Drugs (OGD) is becoming a separate CDER super office and will operate more like CDER's Office of New Drugs, with
responsibility for reviewing bioequivalence, microbiology, and clinical data and clearing product labels. More details about
the reorganization and OPQ should emerge over the next six months.
The regulations for CMC submissions and GMPs cover much of the same territory, so it makes sense to bring together the staff
members that evaluate them, commented Jon Clark, OPS associate director for regulatory policy, at the IQ symposium. One advantage
of the new structure is that it will encourage discussion of GMPs much earlier in the development process and hopefully avoid
the kinds of production delays that could stymie market approval. The appointment of Howard Sklamberg, deputy associate commissioner
for regulatory affairs, to head CDER's compliance office also brings in someone highly familiar with FDA's field force operations
to help shape new inspection models.
Woodcock is hopeful that this reorganization and other initiatives will promote better ways to ensure drug quality, while
also encouraging innovation. The current system for monitoring manufacturing activities is highly resource intensive, yet
it fails to direct oversight to higher risk situations. "We're not just moving boxes," she insists, but looking to focus more
on data surveillance and metrics, instead of site inspections, to provide faster review of applications plus improved procedures
for ensuring quality manufacturing around the world.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, jwechsler@advanstar.com
. Read Jill's blogs at
http://PharmTech.com/wechsler.
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