New FDA strategic roadmap includes health IT-related goals

The U.S. Food and Drug Administration this week unveiled a new roadmap that outlines its strategic priorities through 2018.

According to FDA Commissioner Margaret Hamburg (pictured), the plan--which includes many health IT-related goals--was in development for more than a year.

"More often than not today, a drug or medical product that ends up on the shelves of an American drugstore or in our hospitals will come, at least in part, from some foreign source," Hamburg said in a blog post touting the roadmap. "Nearly 40 percent of finished medicines that Americans now take are made elsewhere, as are about 50 percent of all medical devices. … These and other new challenges and transformative developments in global science, technology and trade are rapidly altering the environment in which we work to fulfill our broad public health mission. In order to continue to carry out that mission, we need a set of clearly defined priorities and goals, as well as the strategies for reaching them."

One objective of the plan, for instance, is to strengthen detection and surveillance of problems with FDA-regulated products. The agency points to its implementation of unique device identifiers over the next seven years as a way to achieve that goal, saying that they will strengthen the information base concerning device performance.

In June, the FDA released guidance to manufacturers for submissions to its Global Unique Device Identification Database.

Within that same objective, the agency highlights its Sentinel Initiative as a "proactive system that complements existing systems" that allows FDA to more easily keep track of adverse event reports by "actively query[ing] healthcare data holders--like electronic health record systems, administrative and insurance claims databases and registries."

FDA's Mini-Sentinel pilot program uses claims and EHR data from 18 large healthcare organizations, serving as data partners, to provide answers to FDA questions about drug safety. Participating partners include Kaiser Permanente, Aetna, the University of Pennsylvania and Weill Cornell's School of Public Health.

Another stated objective is to improve the predictability, consistency, transparency and efficiency of the review process. FDA's device approval process came under fire this week in two studies published in JAMA Internal Medicine.

One way FDA is working to improve transparency is through the agency's launch this week of a new online dashboard that posts information on its inspections, warning letters, seizures and injunctions, and statistics. Currently, the dashboard provides information from FY 2009 through FY 2013, and FDA plans to update the information semi-annually.

"FDA works within a global environment and is carrying out more inspections around the world," Douglas Stearn, director of the Office of Enforcement and Import Operations within the agency's Office of Regulatory Affairs, said in a blog post on the dashboard. "We collaborate with regulatory authorities across the globe to protect public health. Our data dashboard provides information about inspections in this global environment, and makes this information more readily accessible to the public. Now you can use the dashboard to see this kind of inspection-related information to better understand our regulatory decisions."

To learn more:
- here's the roadmap (.pdf)
- check out Hamburg's blog post
- read Stearn's post

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