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 "Senator Seeks Halt to FDA Moves on Mobile Medical Apps," written by Brett Norman.
Following is an excerpt:
Sen. Michael Bennet is pushing to add language to the FDA user fee legislation that would put an 18-month moratorium on the agency's guidance for regulating mobile medical apps.
The FDA is pushing back.
If the addition championed by the Colorado Democrat succeeds over FDA objections, it would be a crack in what has so far been a remarkably robust set of compromises between the agency, the industries it regulates and Republicans and Democrats. Both the Senate and the House want to wrap up work on the bipartisan user fee legislation quickly.
On Tuesday, Bennet praised the user fee negotiations as "a singularly and uniquely good process" and said the legislation "shouldn't be a vehicle for messaging amendments or extraneous amendments." But he also told reporters he planned to move forward with efforts to include the moratorium on the draft guidance because the parties involved should "stop for a second and take a breath."
Bennet and Sen. Orrin Hatch (R-Utah) offered an amendment with the moratorium language during the Senate HELP Committee markup of the bill last month, but withdrew it before a vote ?...
"In all honesty, it would just leave everybody in the dark," said Brad Thompson, an attorney who works with the mHealth Regulatory Coalition, which is pushing FDA to relax some of its proposed restrictions on health related apps. "We are quite willing and quite happy, frankly, for the FDA to move forward with the guidance documents. Open and direct discussion with the FDA is the best way to address the issues, not some legislative amendment."
