A new Nature editorial. Pay heed or pay later.
Getting what you pay for
Getting what you pay for
US, 26 Nov 2009 - 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 (see page 406) 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. But in 2008, Congress gave enough money to fund only 55 staff for this job. With some 71,000 industry submissions in 2008, those employees can cope with only a small fraction. Similarly, because drug and device fees are dedicated largely to funding reviews for market approval, other functions at the agency, most notably food safety, have received short shrift.
Calls for more cash inevitably raise red flags in this era of ballooning deficits, but the imbalance between the FDA's means and its responsibilities makes the need inescapable. A bipartisan group including six former FDA commissioners and three former heads of the agency's parent department, the Department of Health and Human Services, has publicly urged Congress to boost the agency's appropriations. So have almost all FDA-regulated industries, including the Grocery Manufacturers Association, the Medical Device Manufacturers Association and most major drug companies, as well as dozens of patient groups.
How much extra money is enough? The FDA's science board was asked the same question by Congress in late 2007 after the board issued a scathing report on the agency's eroding scientific capabilities (see Nature 450, 1143; 2007). To set things right, the board concluded last year, Congress would need to add $450 million to the agency's budget in 2010, and $460 million each year between 2011 and 2013.
The administration of President Barack Obama has asked Congress for a further $295 million for the agency in 2010, which would bring its congressional appropriations to $2.3 billion — less than what is needed, according to the science board's estimates, but "a good start", as Hamburg told Nature earlier this month. Congress should provide at least that much, and make plans to boost that figure in subsequent years.
Historically, it has taken crises to goad legislators into giving the FDA the money and muscle it needs — a notable example being the poisonous cough syrup that killed more than 100 people in 1937, and led to the 1938 enactment of the Federal Food, Drug, and Cosmetic Act, which still forms the basis of the FDA's authority. Congress shouldn't wait for the next crisis.
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. But in 2008, Congress gave enough money to fund only 55 staff for this job. With some 71,000 industry submissions in 2008, those employees can cope with only a small fraction. Similarly, because drug and device fees are dedicated largely to funding reviews for market approval, other functions at the agency, most notably food safety, have received short shrift.
Calls for more cash inevitably raise red flags in this era of ballooning deficits, but the imbalance between the FDA's means and its responsibilities makes the need inescapable. A bipartisan group including six former FDA commissioners and three former heads of the agency's parent department, the Department of Health and Human Services, has publicly urged Congress to boost the agency's appropriations. So have almost all FDA-regulated industries, including the Grocery Manufacturers Association, the Medical Device Manufacturers Association and most major drug companies, as well as dozens of patient groups.
How much extra money is enough? The FDA's science board was asked the same question by Congress in late 2007 after the board issued a scathing report on the agency's eroding scientific capabilities (see Nature 450, 1143; 2007). To set things right, the board concluded last year, Congress would need to add $450 million to the agency's budget in 2010, and $460 million each year between 2011 and 2013.
The administration of President Barack Obama has asked Congress for a further $295 million for the agency in 2010, which would bring its congressional appropriations to $2.3 billion — less than what is needed, according to the science board's estimates, but "a good start", as Hamburg told Nature earlier this month. Congress should provide at least that much, and make plans to boost that figure in subsequent years.
Historically, it has taken crises to goad legislators into giving the FDA the money and muscle it needs — a notable example being the poisonous cough syrup that killed more than 100 people in 1937, and led to the 1938 enactment of the Federal Food, Drug, and Cosmetic Act, which still forms the basis of the FDA's authority. Congress shouldn't wait for the next crisis.
