Understanding the Scope of FDA's Inspection Authority and Its Ability to Access Company Records

Why Should You Attend:

Companies that manufacture products regulated by the USFDA are subject to inspection by the Agency, although the scope of FDA’s authority varies with the type of product being produced. Nevertheless, FDA investigators are trained to ask for information to which they are not legally entitled, in the hope that companies will provide such information “voluntarily.” Company personnel need to understand these limits (and how to respond when FDA tries to go beyond them) to protect their businesses.

This session is designed for manufacturers of foods, dietary supplements, cosmetics, pharmaceuticals, and medical devices. It will provide a clear overview of the extent of FDA’s inspection authority and what limits apply to different categories of products. It will also present many practical considerations to help companies prepare for an FDA inspection, deal with inspectors who may try to push the limits, and know when it may be appropriate to take firm stand against providing certain information.

Areas Covered in the Webinar:

• Scope of FDA’s inspection authority for different categories of products.
• What the issues discussed in FDA’s July 2013 draft guidance on “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” mean for pharmaceutical companies.
• How to prepare for an inspection and steps to take to ensure that the event is handled correctly and efficiently.
• Keys to setting the tone for the inspection once the investigator has arrived.
• Successfully pushing back against FDA requests to take photographs or have access to excluded information.
• Considering when it may benefit the company to provide more information voluntarily.
• One thing not to do when asked by an FDA investigator.

Who will Benefit:

This topic applies to personnel/ companies in food, dietary supplements, cosmetics, pharmaceuticals, and medical devices industry. The employees who will benefit most include:

• In-house counsel
• Regulatory affairs managers
• Quality assurance/quality control personnel
• Production facility workers
• Corporate risk managers
• Audit
• Senior Management

Instructor Profile:

Frederick A. Stearns, is a partner in the law firm of Keller and Heckman LLP’s Washington, DC, office, where his practice involves a wide range of issues facing manufacturers of prescription and over-the-counter drugs, medical devices, dietary supplements, and cosmetics. He helps product manufacturers evaluate the need for marketing approval from FDA, pursue appropriate clearance when necessary, and address regulatory compliance issues with marketed products (including OTC drug monographs, product labeling and promotion, and current good manufacturing practices). Mr. Stearns also works with clients to respond to FDA enforcement activities, navigate the interrelationship of the patent laws and the FDA drug approval process, communicate with Agency officials, and develop innovative strategies to deal with evolving FDA regulatory requirements. In addition, Mr. Stearns works with companies to conduct FDA due diligence reviews, both for internal control/compliance assessment purposes and as part of product line or corporate acquisitions.

He is a frequent speaker at conferences on the legal issues involving the regulation of drugs, medical devices, dietary supplements, and cosmetics.

Mr. Stearns received his B.S. in Applied and Engineering Physics from Cornell University in 1988 and his J.D. with honors from The George Washington University Law School in 1993. He is a member of the District of Columbia and Virginia Bars.

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