My career in FDA would not be complete if I do not mentioned the terrorist bombing of the World Trade Center in New York and the Pentagon in Washington, D.C. I remember clearly what I was doing and how I felt afterward. That morning in September 11, 2001, The office of New Drug Chemistry had a joint meeting with representatives of Pharmaceutical Manufacturers Association (PHARMA) at the Hilton Hotel in Gaithersburg, MD. At about 9:20 AM, we received an announcement that the meeting is canceled and we can go home, since the World Trade Center in New York was burning. All of the attendees went to the hotel lobby and the TV was announcing the news. I felt sick, depressed but helpless to see the burning WTC building. Later, I learned that the Pentagon in Washington DC was also bombed and another plane crashed in the field somewhere in Southern Pennsylvania. I also found out that this United Airline plane was intended for the White House. Had it not been for the courageous heroics of several passengers, the White House would have suffered the same fate as the WTC and the Pentagon.
The most heinous crime of the century produced thousands of burnt victims. Two drugs in my Division, Sulfamylon and Silvadene, approved for the treatment of burns were out of supply. A chemistry manufacturing supplement has to be approved as soon as possible to manufacture more of these ointments in a new facility. This required a review by the chemist, an inspection of the facility by a field inspector, my approval as the chemistry team leader plus the paper work by the project manager. The drugs are needed immediately, so we have to do an expedited review of the manufacturing supplement. It took us only 12 hours to approve the new facility and the review of the chemistry supplement and its manufacturing and control procedures. This review normally will take at least one month to three months depending on the availability of the field inspector and the schedule of the review chemist.
In December, 2001, the four members of my review team received a special cash award and recognition award from FDA management for our work on expediting review of two drugs, Sulfamylon and Silvadene. Of my more than a dozen awards I had, this one is the most appreciated. I felt that I have done my job as a public servant and had helped the victims of the terrorist attack in a timely manner.