Crawford steps down at FDA, Hussain reportedly moving on

11/01/2005

ROCKVILLE, Md. - After only a two-month stint as commissioner of the Food and Drug Administration (www.fda.gov), Lester M. Crawford submitted his resignation on Sept. 23, reportedly via an internal e-mail to FDA staff. Neither Crawford nor the agency offered official comment on the resignation. The commissioner had been under pressure in recent months from both political parties for agency response concerning drug safety and emergency contraception.

National Cancer Institute Director Andrew von Eschenbach will serve as acting commissioner in Crawford’s absence. The search and congressional approval for a new commissioner is expected to take several months.

The agency also announced that Ajaz Hussain, director of the Office of Pharmaceutical Science (OPS), is leaving to become vice president and global head of biopharmaceutical development at German pharmaceutical maker Sandoz. While at the FDA, Hussain is credited for significant roles in developing the Center for Drug Evaluation and Research’s (CDER) Scale-up and Postapproval Changes as well as the Biopharmaceuticals Classification System.

In a related item, CDER says it has officially launched its Office of New Drug Quality Assessment (ONDQA), formed from the Office of New Drug Chemistry (ONDC). Dr. Moheb Nasr, director of the ONDC and keynote speaker at this year’s CleanRooms Contamination Control Technology (CCT) conference and exhibition in Boston, will head the new office. Using a science-based approach, the ONDQA’s mandate is to assess chemistry, manufacturing and controls sections of investigational new drugs and new drug applications.

Speaking at the CleanRooms CCT conference in March, Dr. Nasr announced that the agency, responding to industry concerns that its policies hinder new drug development, is now aiming for risk-based assessments rooted in science-based policies and standards.

“If you make your decisions based on science, you can’t go wrong,” he explained.