Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “Latest Senate FDA Reform Bill Would Delay Guidance on Mobile Health Apps,” written by Rebecca Kern.
Following is an excerpt:
A new provision in the Senate FDA user fee and reform bill would prevent issuance of an FDA guidance on the regulation of mobile medical applications software until the agency submits a report to Congress.
The broad-based bill was formally introduced in the Senate May 15 and is likely to be debated on the floor this week. It was approved by the Senate Health, Education, Labor and Pensions Committee in April. Since then, lawmakers have made some changes, and backroom negotiations over other provisions that could appear on the Senate floor continue. …
The new language would put a hold on FDA finalizing its mobile medical apps draft guidance until after the agency reports to Congress on its proposed strategy for an appropriate, risk-based regulatory framework for health information technology software, including mobile applications. HHS would be required to work with FDA, the National Coordinator for Health Information Technology and the Federal Communications Commission to submit the report no later than 18 months after the law is enacted. ?…
The mHealth Regulatory Coalition, which represents companies developing mobile health products, is against statutory language that would hold up the FDA process, said Bradley Thompson, an attorney who represents the coalition.
Although the coalition is pressing FDA to provide clarity on more issues, it does not want to see the policymaking process slowed down, particularly by an act of Congress, Thompson, with Epstein Becker & Green, said in an interview.
“We need to understand the rules of the road,” Thompson said, citing many positive policies in the draft guidance.