Six U.S. senators are asking the U.S. Food and Drug Administration for greater transparency and clarification regarding regulatory review of mobile medical applications and want specific answers on a wide range of issues from rulemaking and establishment of standards to Congressional oversight.
In a letter to FDA Commissioner Margaret Hamburg dated March 18, the lawmakers state better clarity is needed on FDA policy to ensure consumer protection and safety and to spur technology innovation.
"It is important for the FDA to be well-equipped with the proper tools to be able to advance public health while taking care that innovation is not stifled through uncertainty or over-regulation," states the letter, signed by Sens. Michael Bennet (D-Colo.), Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Mark Warner (D-Va.) and Richard Burr (R-N.C.). "While the FDA's final guidance has provided clarity on the agency's approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated."
The action comes as healthcare apps increasingly are hitting the market and quickly progressing from providing basic health and fitness monitoring data to providing medical diagnostic capabilities. According to the latest Citrix Mobile Analytics Report, the top 10 most popular mobile health apps by subscriber usage are related to fitness and running, weight loss and nutrition and women's health.
The issue of regulatory oversight is a hot issue given a proposed bill--the Preventing Regulatory Overreach To Enhance Care Technology Act of 2014--which aims to curb FDA influence on mobile software. The PROTECT Act is being proposed by Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine), and has drawn criticism from the mHealth Regulatory Coalition, which says the proposal poses serious risks to patients. The coalition believes Congress must play a key role in ensuring FDA guidance on mobile applications.
For more information:
- read the letter (.pdf)
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