Staff Writer

SAN DIEGO - Sunny San Diego continued to live up to its name on Friday, offering blue skies and warm breezes as the remaining attendees of the 2008 Biotechnology Industry Organization meeting scurried to last-minute meetings, watched the final panels and packed up their exhibit hall booths.

With slightly more than 20,000 registrants, this year's gathering was a little smaller than last year's Boston bash. And with the crowd spread out among so many simultaneous session tracks, company presentations, one-on-one meetings and exhibit hall booths, the conference never felt all that crowded - except when folks started lining up hours early to hear Governor Schwarzenegger speak during Wednesday's lunch.

Although the convention center halls began to empty late Thursday afternoon as visitors from 70 countries headed home, one panel that still managed to draw a decent crowd was FDA Town Hall, in which Deborah Henderson, director of the office of executive programs, provided a summary of the agency's near-term goals.

Top of mind at the FDA is implementation of the 2007 FDA Amendments Act (FDAAA), a "huge piece of legislation" that Henderson said will require significant effort to "figure out what Congress actually meant."

Included in FDAAA - and of primary interest to the biotech industry - is PDUFA IV.

Henderson said the agency's focus in executing the recently reauthorized act is to maintain its current services while improving information technology infrastructure and enhancing both premarket and postmarket activities.

As far as premarket reviews, Henderson said the agency is trying to "make things more transparent and predictable" and "end a lot of the last-minute activity" associated with approvals. Whether that will increase the number of first-cycle approvals remains to be seen; although approvable letters are on the rise, Henderson said she "can't think of anything in the current environment that would indicate a trend" toward multiple-cycle approvals and simply advised companies to "pay attention to the advice the FDA gives you."

Postmarketing surveillance also will become a top priority at the FDA, and PDUFA fees now will help fund those efforts. Additionally, the new Safety First and Safe Use initiatives give the agency more authority to require postmarketing trials, as well as risk evaluation and mitigation strategies and labeling changes.

As part of the heightened emphasis on safety, FDAAA requires the FDA to reduce conflicts of interest in its advisory committees. That mandate particularly is vexing, Henderson admitted, because it is "almost impossible" to find qualified experts without conflicts. "It may get to the point where we can't find the people we need," she said, which also presents a challenge because Congress has mandated more advisory committee panels.

And while finding less conflicted committee members is hard, finding employees is even harder. Henderson said the agency is about 460 people short of being fully staffed and is working hard to remedy the situation. She said that contrary to industry concerns, it is a shortage of employees rather than an increased focus on FDAAA that recently has caused the agency to miss a few PDUFA dates.

Looking to the future, Henderson expects to see more discussion - and potential legislation - regarding generic drug user fees, biosimilars and the safety of imported products. She also said that the FDA is "stepping up to the plate" to ensure that physicians and patients have the information they need to use drugs safely, rather than just approving new products and "throwing them over the wall."