Perhaps out of embarrassment at the stream of incidents involving contaminated products, the US Food and Drug Administration has requested the largest budget increase in its history. The agency intends to use part of the funds for its proposed Safer Medical Products initiative, which will scrutinize domestic and imported drugs. Will it use the money wisely?
Some details that FDA has given about its plans are encouraging. For example, it intends to increase the number of field tests of imported drugs from roughly 2870 this year to 6197 next year. The agency also wants to inspect more high-risk international and domestic manufacturing facilities than before. The target is 700 for 2010, which is 100 more than this year. Sounds good so far.
But here’s the catch. The number of unique FDA inspections of domestic and international facilities will remain the same in 2010 as in 2009. If the agency focuses on high-risk facilities, couldn’t problems easily crop up elsewhere, like in a frustrating game of whack-a-mole?
FDA’s stated intention to rely on state authorities and on international regulators’ inspection data could provide us additional protection. FDA has more than 70 agreements to share manufacturing information with regulators in countries such as China.
I’m all for cooperation, but I’d be more reassured if Congress gave the agency more muscle so that it could stand on its own. The Drug and Device Accountability Act of 2009, recently introduced by Senator Grassley, would give FDA more funds and more authority. The bill would increase the agency’s power to inspect foreign and domestic drug-manufacturing facilities and give FDA the power to issue subpoenas and detain products at the border if it suspected they were adulterated or misbranded.
The budget request is a good start, but the agency needs even more tools to ensure drug safety effectively.