Getting what you pay for
The US Food and Drug Administration cannot fulfil its mandate without a serious funding boost.
The US Food and Drug Administration (FDA) is in capable new hands. Its commissioner, Margaret Hamburg, a Harvard-trained physician six months into her tenure, brings to the job both a broad experience in science, public health and biosecurity and an ability to handle multiple, simultaneous demands -- a skill she displayed as New York City's youngest health commissioner.
For all her abilities, however, Hamburg is struggling to steer an underpowered ship that is loaded to the gunwales. The 103-year-old agency, based in Silver Spring, Maryland, has never before had so many demands placed on it, nor has its budget ever been so constrained relative to its duties. Between 2001 and 2007, for example, the number of US food-manufacturing plants under the FDA's jurisdiction increased from about 51,000 to more than 65,000, yet the number of staff in its foods programme fell from 3,167 to 2,757. At current inspection rates, any given domestic food company faces a less than one-in-four chance of being inspected once in seven years. And that looks frequent compared with the agency's estimated average inspection rate for foreign manufacturers of medium-risk medical devices: once every 27 years.
It is true that the FDA's funding has been boosted since 1993 by user fees paid by drug- and device-makers. In 2009, such fees amounted to nearly 23% of the agency's $2.7-billion budget. But this influx has, paradoxically, taken the pressure off Congress to fund the many mandates it continues to heap on the agency. For instance, the FDA is expected to monitor the accuracy of direct-to-consumer advertisements by drug companies, and the promotional materials they send to physicians.