Changes and Controversy at CDER

The heavy buzz at the recent fall technical conference sponsored by the Generic Pharmaceutical Association (GPhA) involved proposals for reorganizing the Office of Pharmaceutical Science (OPS) in the Center for Drug Evaluation and Research (CDER). A few weeks ago, CDER director Janet Woodcock announced plans to elevate the Office of Generic Drugs (OGD) to “super office” status, pulling it out of OPS so that its director Greg Geba would report directly to her.

While most of OGD would move, there also is talk of leaving OGD chemists in OPS so they can work more closely with their colleagues involved with reviewing the CMC sections of new drug applications (NDAs). OPS would be reshaped into the Office of Drug Quality (ODQ), housing all the chemists, research scientists and also some functions of the CDER Office of Compliance involved with oversight of good manufacturing practices (GMPs).

A number of regulatory and manufacturing experts at the GPhA conference privately voiced skepticism about separating the generic drug chemists from the rest of OGD, particularly at a time of extensive change and expansion for that office. OGD is under pressure with the advent of generic drug user fees to make the approval process for abbreviated NDAs (ANDAs) more efficient. The office will be hiring and training some 300 new staffers to that end, about half of them chemists. Yet some OPS officials said that it makes sense for all the chemists to be more collaborative, and that a new cadre of  “regulatory policy managers” will coordinate OGD review functions (labeling, bioequivalence, microbiology) with chemistry and compliance.

There’s a déjà vu quality in this discussion. Years ago, all the chemists worked together until those involved with ANDAs split away from those dealing with NDAs, a shift designed to better coordinate the ANDA review process. It’s not clear that it now makes sense to put the chemists back together again, but separate from the rest of the generic drug review operation.