Tuesday, November 5, 2013

FDA working on drug shortages smartphone app

The FDA has moved tentatively into the world of smartphones and social media, with its guidance often lagging behind industry expectations and its own activities being grown carefully. These in-house initiatives are now due to gain a new component. The FDA is working on a drug shortages smartphone app.

The app is part of a strategic plan the FDA devised after gauging through comments to a Federal Register notice what people want. This process reiterated that people want real-time information on drug shortages, with healthcare systems particularly keen to know how long they will last and what alternatives are available. "We recognize we need to improve our communications … with the public and healthcare providers about drug shortages," FDA deputy director of regulatory programs Dr. Douglas Throckmorton told reporters on a call attended by FierceBiotech IT.

Work on the smartphone app is progressing alongside efforts to improve the FDA drug shortages website. The U.S. authority plans to add therapeutic categories to the website, as well as giving users the ability to sort and search the data. The goal of both the smartphone app and website

improvements is to make information "more accessible and user friendly," particularly for people who are only interested in a specific therapeutic area, Throckmorton said. The FDA is yet to disclose whether it is developing the app for Android or Apple ($AAPL) devices, or when it expects to introduce the product.

An unofficial app performing a similar function--RxShortages--was introduced on Apple devices in 2010 and is also available on Android. The app relies on information from the FDA and the American Society of Health-System Pharmacists. The FDA is adding its own app to what it sees as a successful push to end and prevent drug shortages. Last year there were 117 shortages, less than half the number in 2011. The FDA claims the decline was partly caused by its work to prevent shortages. In 2012 it prevented 282 shortages, compared to 195 the previous year.

The declines come during a period in which the FDA has struggled to secure the funding it believes is needed to protect U.S. patients in the era of globalized drug supply. Despite these travails, Throckmorton is certain the FDA will have the cash for the shortages program. "This is a high priority for FDA. We're going to find the resources that are needed for us to do the job," he said.


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