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.
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.
People
Related News
17 April 2024
In the News
Steven Barth on Allure of Take-Private Deals – 'Public markets aren’t what they’re cracked up to be'
Foley & Lardner LLP partner Steven Barth offers extensive insight on the growing trend of family-owned consumer and retail businesses aiming to go private in the Axios article, “Family-owned companies see allure in take-private deals.”
16 April 2024
In the News
Claire Marblestone Assesses Increased Scrutiny of CA Health Care Transactions
Foley & Lardner LLP partner Claire Marblestone is quoted in the Law360 article, “Struggling Hospitals Seek Mergers As Regulators Push Back.”
15 April 2024
In the News
Nathaniel Lacktman Joins Double Take by Newton Podcast to Talk Telemedicine
Foley & Lardner LLP Nathaniel Lacktman appeared on Newton Investment Management’s Double Take by Newton podcast episode “Modernizing Medicine” to discuss the health care industry’s digital evolution and the benefits of telemedicine.