In January 2011, control of the US House of Representatives will shift to the Republican party. Reducing the federal deficit is one of the party’s top priorities, and Republican leaders have proposed to cut domestic spending as a means to accomplish this end. But should all programs be put on the chopping block?
Not everyone thinks so. Margaret Hamburg, commissioner of the US Food and Drug Administration, told the Reuters Health Summit last week that lawmakers should think carefully before cutting taxpayer funding for her agency. “It should be recognized if we can’t do our job and do it well there isn’t any other entity that will backstop behind us,” said Hamburg.
Indeed, the agency’s “responsibilities outstrip our resources,” according to the commissioner. Despite budget increases, FDA struggles to perform its growing list of duties, which now includes regulating tobacco.
Hamburg is not alone in her assessment. Budgetary constraints have led FDA to use a risk methodology to target pharmaceutical manufacturing sites for inspection, but this approach is less than rigorous, according to a paper by Warren Adis, associate professor of information sciences at Iona College in New Rochelle, New York. “By failing to specify quality-assurance violations, the FDA is not providing the necessary oversight and guidance to the pharmaceutical manufacturing industry,” said Adis.
And FDA’s response to the increase in internationally outsourced drug manufacturing has not been strong enough, Hamburg acknowledged at the summit. She may have been thinking of the US Government Accountability Office’s recent report, which urged the agency to inspect more foreign manufacturing sites. In fiscal year 2009, FDA inspected only 11% of sites on its list of foreign establishments, according to the report. One of the report’s disturbing findings is that the agency may never have inspected about 64% of the foreign establishments in its inventory for 2009.
If we accept the premises that reducing the deficit should be an urgent priority and that we must cut spending do it, I don’t think that FDA’s funding should feel Congress’s budgetary blade. The public record contains ample evidence that the agency, which is struggling valiantly, is falling short of fulfilling its goals. Hamburg is right—no person or group stands ready to fill FDA’s shoes should the agency falter. Reducing taxpayer funding for the agency would raise citizens’ risk of exposure to tainted, subpotent, or superpotent drugs.
Public health seems to demand more money for the agency, not less. If it wants to reduce the deficit, Congress should find and eliminate waste from the budget. If boosting FDA’s funding is not politically feasible, Congress should at least leave it intact.