Senate bill undermines FDA regulatory role

Congressional efforts to amend the Federal Food, Drug and Cosmetic Act and to limit the FDA's statutory authority in regulating clinical and health software are not restricted to the House of Representatives. If you thought the SOFTWARE Act in the House was an isolated piece of legislation, then you should see what is brewing in the Senate. 

Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) announced that they introduced a bill--the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014--that targets the FDA's role. Like its companion bill in the House, the PROTECT Act in the Senate tries to paint a picture of the FDA as a maniacal, overreaching regulatory agency that is stifling innovation in the nascent mHealth industry. 

"Under current law, the [FDA] can use its definition of a medical device to assert broad regulatory authority over a wide array of low-risk health IT, including mobile wellness apps, scheduling software and electronic health records," states the announcement.

An earlier draft of the bill obtained by FierceMobileHealthcare charged that the FDA "has sought to expand its enforcement discretion by regulating the dynamic mobile health and mobile applications market" through its September 2013 release of final guidance on mobile medical apps, and the "role that the [FDA] has taken in regulating such technology exceeds the role Congress expected the agency to take." 

"In so doing, the [FDA] has set aside economic impact analysis and failed to defer to Congress' stated preference under the Food and Drug Administration Safety and Innovation Act (Public Law 112–144) that the agency make recommendations to Congress about a new risk-based, regulatory framework [for health IT including mobile medical apps]," stated the earlier draft of the bill. 

So, in other words, according to the senators, the FDA should never have issued its final guidance on mobile medical apps--an argument we have heard before. Not surprisingly, the PROTECT Act is supported by some of the same interests--IBM, Verizon, athenahealth, Software & Information Industry Association, McKesson--and under the proposed legislation clinical and health software would not be subject to regulation.

"The biggest issue with both the SOFTWARE Act and the PROTECT Act is that it would deregulate certain standalone software used for such things as guiding therapeutic decision-making," Bradley Merrill Thompson, the mHealth Regulatory Coalition's general counsel, told FierceMobileHealthcare. "For example, under both acts, a radiation dosage calculator would be removed from FDA regulation even though there is considerable risk in using such a program."

However, the PROTECT Act goes even further than the SOFTWARE Act in attempting to reduce the FDA's authority in such matters. The proposed legislation would make the National Institute of Standards and Technology the federal agency with oversight responsibility for technical standards used by clinical software. 

In addition, NIST, in collaboration with the Federal Communications Commission, the National Patient Safety Foundation and the Office of the National Coordinator for Health IT, "should work on next steps, beyond current oversight efforts, regarding health information technology, such as granting nongovernmental entities the authority to recommend certification processes and to encourage best practice standards," states the bill.

"Fundamentally the Senate legislation would make NIST responsible for technical standards and take FDA completely out of the equation," said Thompson. "That's just a terrible idea. FDA has a lot of experience in this area. They also have statutory authority that would be useful to regulating certain types of high risk health IT."

Legislators like to talk a good game about the creation of a new risk-based regulatory framework that "reduces regulatory burdens, promotes patient safety, and fosters innovation" yet that is precisely what we got in September with the FDA's final guidance on mobile medical apps. I don't know about you, but I've had enough of the FDA bashing from proposed legislation such as the PROTECT Act.

It's time for Congress to step aside and let the regulatory agency do its job without making changes to the existing law that in the end will only cause harm. - Greg (@Slabodkin)