James Boiani, Bradley Merrill Thompson Quoted in “Trump’s Two-for-One Reg Order Needs Agency Interpretation, Medtech Reg Experts Say”

Medtech Insight

James Boiani and Bradley Merrill Thompson, Members of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, were quoted in Medtech Insight, in “Trump's Two-for-One Reg Order Needs Agency Interpretation, Medtech Reg Experts Say,” by Ferdous Al-Faruque. (Read the full version – subscription required.)

Following is an excerpt:

James Boiani, an attorney with the law firm Epstein Becker Green who specializes in regulations for clinical diagnostics, says the order is written too broadly to provide a detailed interpretation in isolation. Each agency will need to interpret the language to determine the impact on regulators such as FDA and the industries they oversee, he told Medtech Insight. The fact that a permanent Health and Human Services Secretary has yet to be confirmed and a permanent FDA commissioner has yet to be nominated is likely to further delay full interpretation of the orders, he suggested.

“Regarding the definition of a regulation, is it a chapter/part in the CFR, or a section, sub-section, subparagraph, etc. that makes a regulation?” asks Boiani. “Will agencies ultimately get around this by condensing regulations?”

Bradley Thompson, a colleague of Boiani's and a device regulatory expert, says, based on the definition set forth by the order, he does not think a guidance document will necessarily be considered a regulation if the document's subject is “truly” addressed through the guidance.

“In the two-for-one document issued today, they do not say that regulation includes guidance documents,” Thompson said. “[It] makes me wonder if that's intentional. I could see them freezing all pronouncements, whether regulations or guidance documents. I could see them separately imposing these limits on new regulations because new regulations include new requirements, where guidance documents clarify existing requirements and thus there is not the need for the two-for-one limit.”