Beaver Addresses Effect of New DOJ Policy on FDA Enforcement Actions

05 April 2018 Food Quality & Safety News
Partner Nate Beaver was quoted in an article for Food Quality & Safety, “What DOJ’s Policy on FDA Guidance Really Means,” about the impact that a new Justice Department policy prohibiting government litigators in civil cases from using noncompliance with guidance documents to prove violations of federal law will have on FDA enforcement actions.

Beaver said the change will make it more challenging for the FDA to pursue violations, especially where the agency has chosen to issue guidance documents rather than set rules. He also pointed out that one of the first steps the Trump administration took was an executive action that requires agencies to eliminate two rules for every new rule they finalize. Given that, he said, the FDA is likely to continue to avoid rulemaking except where absolutely necessary.

Related Services

Insights

RCE PTA Carve-Out Resumes After Interference
18 September 2019
PharmaPatents
The Ninth Circuit Expected to Rule that Doctors Can Be Wrong in the Winter v. Gardens False Claims Act Case
18 September 2019
Legal News: Government Enforcement Defense & Investigations
Upcoming Webinar: Maximizing Solar Tax Credits - Navigating the Start of Construction Rules (Part 1)
17 September 2019
Renewable Energy Outlook
When Birds Finally Find a Nest
17 September 2019
Dashboard Insights
Lacktman, Ferrante Cited in mHealth Intelligence About Ryan Haight Act
19 September 2019
mHealth Intelligence
Tinnen Discusses How Viewpoint Diversity Helps Businesses Thrive
18 September 2019
InsideTrack
Vernaglia Comments on AHA v Azar Decision
18 September 2019
MedPage Today
Lach Comments on Launch of New Group
16 September 2019
BizTimes Milwaukee
MedTech Impact Expo & Conference
13-15 December 2019
Las Vegas, NV
Review of 2020 Medicare Changes for Telehealth
11 December 2019
Member Call
BRG Healthcare Leadership Conference
06 December 2019
Washington, D.C.
CTeL Telehealth Fall Summit 2019
04-06 December 2019
Washington, D.C.