When an FDA-regulated company interacts with the FDA, there are a few things on the line, such as consumer and patient well-being, millions or even billions of dollars, and your company’s reputation. Advice on the legal implications and how to be prepared can help you and your team through inspections with the FDA and other health authorities.
Download our recent webinar, Legal Considerations | Interacting with the FDA Before, During, and After Inspections, presented by FDA Law Partner Neil DiSpirito.
Neil discussed the legal concept of the FDA inspection as a Warrantless Search. Removing the 4th and 5th Amendments’ due process clauses in gathering evidence of not just an administrative but civil and criminal nature and what your rights are.
Evidence of these inspection-determined violations may be used to bring legal enforcement actions against the company. To avoid violations and potential enforcement actions, a business must know its rights and have a detailed plan and procedure for interacting with the FDA before, during, and after inspections. And when disagreements or allegations of noncompliance arise during the inspection or review process, having legal counsel readily available to respond and handle these inquiries or actions can be a game-changer and avoid a long regulatory enforcement policy and financial disaster.
The webinar was held on Tuesday, May 23, and the recording is a must for quality professionals and anyone on your team involved with an FDA inspection.
About the Speaker
Neil DiSpirito is an FDA law partner in Brown Rudnick’s Corporate and Global Life Sciences Practice Groups.
Clients call Neil when complex government regulations or decisions threaten their company’s future by jeopardizing transactions, mergers, acquisitions, licenses, new product applications enforcement proceedings, administrative actions, litigation, stalled applications or civil and criminal investigations and complaints.
Neil’s practice focuses on a wide array of regulatory and compliance issues in the pharmaceutical, biologic, supplement, and medical device industries (and related data privacy and security regulatory issues). Neil also advises on many business transactions and filings for FDA-regulated products and companies.
For over two decades, Neil has helped his clients navigate complex government regulations or decisions that impact their future. He has advised all types of life sciences companies on a broad range of U.S. and international regulatory compliance challenges and issues that arise in government regulatory approvals and actions, transactions, mergers, acquisitions, licensing, products liability litigation, and other disputes.
To learn more about Neil, please click here.
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