News

September 23, 2013

Brad Thompson Featured in Article, “FDA Emphasizes ‘Deregulatory’ Efforts in Mobile Medical Apps Final Guidance”

The Gray Sheet, 9/23/2013

Brad Thompson was quoted in an article titled “FDA Emphasizes ‘Deregulatory’ Efforts in Mobile Medical Apps Final Guidance.”


September 5, 2013

Part 2: Set FDA’s Mobile Medical App Guidance Free [MobihealthNews.com]

Bradley Merrill Thompson wrote an article titled “Part 2: Set FDA’s Mobile Medical App Guidance Free” on MobihealthNews.com.

Following is an excerpt:

In response to my prior post on this topic, athenahealth’s VP of Government Affairs, Mr. Dan Haley took the time to write some very thoughtful-provoking comments. I appreciate him taking the time to do so. I think it probably helps everyone to have a thorough debate of these issues. So in the spirit of debate, I’d like to offer a few reactions.

As I said in my original post, it’s important for us all to keep in mind that FDA is already regulating mHealth and the purpose of this guidance is to reduce the scope of that regulation. So the question is – is it useful for FDA at this time to come out with a final guidance on mobile health?

I will explain further why I think it clearly is.

Mr. Haley offers the view that FDA guidance is unnecessary at this point because there will be a new statutory scheme within about a year. After consulting his blog that he referenced in his prior comments, it appears that Mr. Haley is a government affairs professional and an attorney, so I know that he well-understands the process for creating new statutes, but let me recite it for everyone’s benefit.

September 4, 2013

Bradley Merrill Thompson Quoted in Article, “HIT Stakeholders Propose Modernizing, Limiting FDA Role in Oversight”

Inside Health Policy, 9/3/2013

Bradley Merrill Thompson was quoted in an article titled “HIT Stakeholders Propose Modernizing, Limiting FDA Role in Oversight.”

Following is an excerpt:

A key industry attorney and Health IT Now posed differing views about FDA’s role in a tri-agency regulatory strategy for health information technology, with the attorney pushing for FDA to provide clear but flexible oversight while the broad-based stakeholder group said the agency’s role should be limited to medical technologies. The comments come as a federal workgroup is slated to present its final recommendations to the Office of the National Coordinator for Health Information Technology next week.

On Wednesday (Aug. 28) Bradley Merrill Thompson, an attorney with Epstein Becker & Green who is also a member of the FDASIA Workgroup, submitted a white paper to ONC that, like the workgroup’s recommendations, identified several outdated aspects of FDA’s regulatory framework that he said should be addressed so the agency can better regulate the unique aspects of health IT.

To develop regulations that support development and innovation, electronic health should to be protected from over-regulation, he said. For example, FDA should be mindful of the innovation process for HIT and allow for tinkering, Thompson said. He also urged FDA to understand the process for developing and manufacturing health technology is typically non-linear and said the agency should not establish regulations for quality that attempt to make development a linear process.

“Regulatory restrictions in the name of a quality system that attempt to make development a purely linear process are doomed to cause confusion and unnecessary burden,” he said, adding that regulatory obligations that dramatically lengthen product life cycles would also stifle developers’ ability to constantly change and progress.

August 27, 2013

Set the FDA Mobile Medical App Guidance Free [MobihealthNews.com]

Bradley Merrill Thompson wrote an article titled “Set the FDA Mobile Medical App Guidance Free” on MobihealthNews.com.

Following is an excerpt:

I feel like a dissident trying to convince the government to free a political prisoner. That’s a pretty apt description, considering that the FDA’s Mobile Medical App (MMA) guidance document is being held hostage purely on political grounds.

Earlier this year, a DC advocacy group decided they wanted Congress to adopt an entirely different approach to health IT. The group seems to be concerned that regulatory systems adopted years ago may not make sense for the technology of today. I happen to agree with them in many respects. In fact, this week my law firm will submit to the federal government our white paper entitled: “Enhancing Innovation in e-Health through a Systems Approach to Regulation: A Blueprint for FDA Modernization.” The paper is designed to encourage innovation in e-health, and especially mHealth, and outlines specific changes needed to modernize the FDA regulatory system to effectively address unique aspects of e-health.

But somehow, from the fact that the FDA regulatory system is antiquated and in need of modernization, this DC advocacy group concluded that FDA publishing this summer its final guidance on mobile medical apps is a threat to what they want to accomplish on Capitol Hill. I do not understand that. Their concerns do not seem to be based in the substance of the guidance or the regulatory realities facing mHealth entrepreneurs today.

Nevertheless, in a letter that was obliquely written, the advocacy group, together with other groups they invited to join in, requested that HHS slow down its policymaking. Specifically they asked HHS not to release any new agency guidance on HIT until after January 2014 when HHS is scheduled to make strategic recommendations to Congress called for under section 618 of FDASIA. The apparent target for that requested delay is the publication of this FDA MMA guidance.

July 9, 2013

Brad Thompson Interviewed on Pharma Marketing Talk

On April 1st Brad Thompson participated in a conversation for Pharma Marketing Talk entitled, “Beyond Mobile Medical App Guidance: What to Worry About After FDA Publishes Its ‘Final’ Guidelines”. To listen to the conversation click here.

Read stories related to this conversation: here and here.

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