Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA’s Health Care Daily Report, in “Sen. Alexander Begins Investigation Into Agencies’ Use of Regulatory Guidance,” by Nathaniel Weixel.
Following is an excerpt:
Bradley Merrill Thompson, an attorney with Epstein Becker & Green PC, told Bloomberg BNA May 13 his concern is that too many documents are left in draft form. He said there’s not enough collaboration between the agency and regulated industry before the draft documents are released, and there’s no incentive for the FDA to make a draft final if there’s no opposition to it.
However, Thompson said guidances are an important part of how the FDA operates, and can serve everyone so long as the guidance development process improves.
“I don’t recommend moving away” from guidances in favor of more rulemaking, previous Thompson said. “I think FDA has the right balance. The ratio right now is pretty good.”