title: Bringing smart pills to market: FDA regulation of ingestible drug/device combination products.
abstract: Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills like this already exist. These so-called smart pills are an emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges. This article predicts how the Food and Drug Administration will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their "novel mode of action" rather than their "primary mode of action," (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products.
authors: Baker Botts LLP, Palo Alto, California, USA.
authors: Matthew
authors: M
authors: Avery
authors: University of California, Hastings College of the Law, USA.
authors: Dan
authors: D
authors: Liu
mesh_terms: D000284:Administration, Oral; D018795:Device Approval / Q000331:legislation & jurisprudence; D016503:Drug Delivery Systems / Q000191:economics / Q000295:instrumentation*; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence; D054855:Drug-Eluting Stents; D006801:Humans; D007880:Legislation, Drug; D062307:Medical Device Legislation; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*