The lettering above the entrance to the Food and Drug Administration's main building in suburban Maryland says Naval Ordnance Laboratory, and on February 15, it almost seemed like a warning to anyone entering for a meeting held to advise the FDA on pharmaceutical packaging track and trace systems. Industry executives certainly detonated some rhetorical bombs during the two-day meeting.
At one point, Jim Dowden from Genentech strode to one of the microphones in the audience during a Q&A session and prefaced his remarks by saying he promised others there that he would keep his mouth shut, but couldn't hold himself quiet. "When would you like that by?" he asked in exasperation, implying that the FDA would be requiring track and trace of drug packages at some set date, which is not the case (at least not yet).
Mr. Dowden's question underlined some of the confusion at the fully-subscribed, two-day workshop attended by 130-plus industry figures. Connie Jung, senior policy advisor for pharmacy affairs, said she had to turn people away. Rick Seibert, vice president, new business development, Sharp Corporation, tried to register six wee
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