Obama signs FDA safety bill, affirming agency's role in medical app guidance

President Obama yesterday signed the tweaked Food and Drug Administration Safety and Innovation Act, The Hill's Healthwatch blog reports, shoring up the FDA's role in creating guidance for mobile medical apps.

Discussions of the FDA's role in regulating mobile medical apps had taken place as far back as early 2010, and became more tangible last summer when the FDA published draft guidance for such technology.

The West Wireless Health Institute, flanked by health technology and life sciences advocacy groups the BIOCOM and CONNECT, said the signing of the bill will benefit patients by eventually leading to faster medical device innovation and lower costs.

"The entire mobile health ecosystem is developing inherently low-risk technologies to extend care beyond offices and hospitals," Joseph Smith, chief medical officer of WWHI said in a statement. "[T]hese novel, low-risk devices and integrated solutions can be expedited via these changes to the FDA's de novo pathway. It's great to see our region's healthcare innovation community work together with our elected officials on this legislation."

Congress sent the bipartisan-supported bill to Obama's desk in late June, according to Health Data Management, just prior to the Supreme Court announcing its decision to uphold the Affordable Care Act. The timeline is important, according to the Healthwatch post, because any overlap with the ruling could have caused the bill to be "dragged … into a morass of symbolic amendments."

U.S. Department of Health & Human Services Secretary Kathleen Sebelius called the signing of the bill--which also reauthorizes user fees collected by the FDA from the drug and medical device industries and creates a new fee for companies that sell generic drugs--"important to increasing patient access to affordable medicines."

"This legislation will drive timely review of new innovator drugs and medical devices, implement the program proposed in the 2013 President's Budget to accelerate the approval of lower-cost generic drugs, and fund the new approval pathway for biosimilar biologics created by the Affordable Care Act," Sebelius said in a statement.

To learn more:
- read The Hill's Healthwatch blog post
- here's the joint statement from West Wireless, BIOCOM and CONNECT
- here's Sebelius' statement
- here's the bill
- read the Health Data Management article

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