The U.S. Food and Drug Administration (FDA) announced today that it is requesting a budget of $3.2 billion, which represents a 19 percent increase over the current FDA fiscal year budget. Given the recent buzz over the FDA's intent to take a closer look at health and medical applications for the iPhone, we wonder if any of fraction of these billions will go toward sharpening the FDA's ability to regulate the exploding app market.
In early February, Don Witters from the FDA's Center for Devices and Radiological Health announced that he wanted to begin a dialog with the mHealth industry to establish clear pathways and regulations that ensure wireless quality of service, coexistence with other medical systems, data integrity, security and electromagnetic compatibility. Witters said his goal was safe, secure and reliable deployments of wireless technology in healthcare. During a Q&A period Witters asserted that in some cases where an iPhone was part of an mHealth service, it should be regulated as part of that system.
Here are two areas of the FDA's proposed budget that may have some bearing on mHealth services:
The increases include $166.4 million for a "Safer Medical Products" initiative that will provide targeted resources to improve the safety of human and animal drugs, medical devices, vaccines, blood and other medical products. The initiative "will allow the FDA to strengthen safety and security of the supply chain for medical products." So, they're gearing up on resources to better understand new advances in the categories listed above -- mobile apps could be "other medical products".
Another $74.4 million will come from "Current Law User Fees," which will lead to increases for fees that support FDA review of applications for new human drugs, animal drugs and medical devices. So, it'll cost more to get approval.