FDA in bad shape

Sunday, May 4, 2008 | 2:09 a.m.

An announcement last week by the Food and Drug Administration that it hopes to add 1,300 people by fall was not as encouraging as it sounded.

In reality, the hiring plan amounts to a desperate catch-up measure, one that would not begin to compensate for the battering the agency’s budget has taken during the Bush years.

CongressDaily, a Capitol Hill publication, reported in February what a subcommittee of the FDA’s science advisory board had concluded — that the FDA was incapable of adequately performing its oversight responsibilities for drugs, medical devices, food and animal feed, mainly because of severely inadequate funding.

The agency’s administrator, Dr. Andrew von Eschenbach, all but confirmed that assessment in a March speech. The New York Times reported his saying that “peril exists,” and that the FDA “may fail in its mission to protect and promote the health of every American.”

Of the new employees the FDA is seeking to hire, only 600 will be filling new positions. The other 700 will be filling positions that have been left open as people left the agency. The hirings will be funded by emergency money approved last year by Congress and user fees collected from pharmaceutical companies, which pay to expedite reviews of their proposed drugs.

To determine whether the FDA is actually headed for recovery, a truer indicator than last week’s hiring announcement is needed.

The Senate is working on just such an indicator. In his proposed 2009 budget, Bush added $50.7 million in government funding to the FDA’s budget, insufficient to even keep up with inflation. The Senate has passed a budget resolution raising that increase to $375 million.

That amount would allow hiring on the scale necessary to begin fixing the FDA. Only if this budget resolution is ultimately approved will there be an indication that the FDA is headed toward recovery.