FDA pledges clear-and-present industry interaction

The FDA says it wants to be clear as crystal. The agency has been phasing in some "transparency" initiatives, to make it easier for industry and consumers to get the answers they need. The latest round: Phase 3, focusing on "regulated industries," a.k.a. drugmakers and food companies.

Outgoing Deputy Commissioner Joshua Sharfstein presented the plans, and in a release, the FDA detailed a list of 19 initiatives designed to make dealing with the agency a simpler, less frustrating experience. The apparent centerpiece--given that it made the release's headline--is a new website called FDA Basics for Industry, essentially an FAQ on how to do business with regulators. Or perhaps it got top billing because it's the only piece that's ready to go.

Other plans include answering regulatory-related email from industry within five business days and standardizing procedures in field districts nationwide. "Clarity and consistency are pillars of an effective regulatory system that efficiently regulates products essential to health," FDA Commissioner Margaret Hamburg said in a statement. "In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates."

- read the FDA release
- see the Basics for Industry site
- get more from Pharmalot