Bradley Merrill Thompson Quoted in “Device Tax Repeal, FDA’s Actions Affecting Industry Remain Top Issues”

Bloomberg BNA's Health Care Daily Report

Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in Bloomberg BNA’s Health Care Daily Report, in “Device Tax Repeal, FDA's Actions Affecting Industry Remain Top Issues,” by Dana A. Elfin and Michael D. Williamson.

Following is an excerpt:

Bradley Merrill Thompson, of Epstein Becker & Green in Washington, said that the FDA's “regulation of lab developed tests will be enormously controversial.” …

Regulation of health information technology also will get a lot of attention, Thompson said. Federal agencies including the FDA will publish the final report required under the Food and Drug Administration Safety and Innovation Act (FDASIA), and the FDA also will publish guidances on wellness and accessories. In addition, he said, the agency is set to publish a “long-overdue” guidance on clinical decision support software. …

Congress will continue to debate legislation and host hearings on the health IT issue, Thompson said. “Given the opportunities to improve public health through innovative health IT, much is at stake. We need to get this right. FDA has been going too slowly, given the opportunities that are present. But at the same time, we do need to make sure that we adequately protect the patient.”