Companies of all sizes engage Shook, Hardy & Bacon for strategic advice related to products regulated by the U.S. Food and Drug Administration (FDA).

Shook offers the complete spectrum of regulatory and litigation services to help clients bring products to market and keep them there. The firm draws on decades of industry experience to solve the complex legal challenges related to product development, commercialization and post-market enforcement.

We take an innovative approach to minimizing future risk while helping companies efficiently manage the routine but critical tasks required for compliance with the Federal Food, Drug, and Cosmetic Act (FDCC); Food Safety and Modernization Act (FSMA); and Nutrition Labeling and Education Act (NLEA). We also counsel clients on Generally Recognized As Safe (GRAS) determinations.

The products we cover include:

Our team includes seasoned attorneys knowledgeable in all areas of FDA regulation.  Our attorneys have worked at the FDA; completed secondments to global pharmaceutical companies; and served as national litigation defense counsel to leading pharmaceutical and medical device manufacturers as well as some of the world’s largest food, beverage and agribusiness companies.  

We provide comprehensive services related to:

We assist pharmaceutical and medical device clients on regulatory matters throughout the product life cycle—from clinical trials and the premarket review process through post-market compliance. We advise on how best to meet regulatory requirements, including adverse event reporting, Current Good Manufacturing Practice (CGMP) and Quality System Requirements (QSR), as well as appropriate marketing and promotion of the product.

We also assist clients in all aspects of food and beverage product development including: safety, labeling, and promotion including compliance with NLEA and GRAS determinations.  We have advised our clients on the various FSMA rules and how to implement and adopt best practices as outlined in various corresponding FSMA guidance documents.

Regulatory Strategy, Product Development and Product Approvals

We work closely with our clients from the earliest stage of a product’s life cycle. We represent a variety of clients in various disciplines such as research universities, cosmetic companies and global pharmaceutical and medical device companies. We regularly counsel and assist FDA-regulated companies that sponsor product research with federal laws and regulations as they pertain to clinical research, including FDA investigational new drug (IND) and investigational device exemption (IDE) requirements, human subjects’ protections (HSP), adverse event reporting (AE), as well as clinical trial registration and reporting requirements.

We regularly advise clients on obtaining FDA approval or clearance to market drugs, biologics, medical devices and food additives.  For many clients, we assist with regulatory approval strategies that include both assistance with standard requirements but also assisting with thinking outside of the box with novel new technologies.  We assist clients in preparation for advisory committee proceedings, responding to difficult questions from the FDA and appealing adverse decisions regarding clearance and approval.

We also assist food and dietary supplement companies with product formulation, appropriate labeling, and health claims such as nutrient content claims as well as with “structure/ function” claims.

Advertising & Promotion

We assist clients to comply with FDA and Federal Trade Commission (FTC) rules governing advertising and marketing of prescription and Over the Counter (OTC) pharmaceuticals, medical devices, food and beverages, as well as dietary supplements and cosmetics.  Our regulatory practice assists clients navigate both FDA and FTC regulatory and enforcement policies. Our extensive experience allows us to both anticipate and mitigate legal risks across all facets of a products marketing campaign.  We counsel pharmaceutical and medical device clients on proposed marketing materials as well as assist clients who have received regulatory correspondence such as OPDP Warning and Untitled letters, FTC enforcement actions, investigations by state attorneys general, Lanham Act lawsuits, challenges brought before the National Advertising Division (NAD) of the Better Business Bureau and other disputes involving allegations of false or misleading advertising. 

Post-Approval Compliance

We advise FDA regulated companies on compliance with the FDA regulations, guidance, policies and procedures.  We assist in the following areas:

  • Development of effective compliance programs including corrective and preventative action plans for life science companies.
  • Product safety monitoring and timely adverse event reporting.
  • Adherence to Good Manufacturing Practices (GMP) and Quality System Regulations (QSR)
  • Review of pharmaceutical, medical device, dietary supplement and food advertising and promotion.
  • Assist with supplemental application requirements for pharmaceuticals and medical devices.

FDA Enforcement

We assist clients with developing strategies and providing appropriate responses to critical and routine FDA enforcement correspondence.  We assist clients develop comprehensive responses to FDA inspections, FDA Warning Letters, requests for recall, proposed consent decrees and warned seizures.

Product Recalls

We regularly assist FDA regulated companies that manufacture and distribute products throughout the recall process, including working directly with the FDA recall coordinator. We assist both manufacturers and distributors with following best practices to remove and/or correct violative products.  We assist companies develop a recall plan in order to address the depth of recall, need to develop a press release to inform the public and to assist with required recall effectiveness checks.  In addition, we also are able to assist with recalls subject to Consumer Product Safety Commission (CPSC) jurisdiction. [Read More]

Due Diligence and Transactional Support

We conduct FDA due diligence reviews for companies engaging in acquisitions, mergers, licensing deals and investments in regards to FDA-regulated companies and/or products.  Our practice is able to identify and evaluate the myriad of FDA regulatory issues that may affect the overall worth of the proposed transaction.  We are able to work closely with corporate deal counsel to assist in both the negotiations and drafting appropriate terms.

Litigation 

Known as a “litigation powerhouse,” Shook represents clients in the U.S. and abroad in individual, class action and multijurisdictional actions. Named “Product Liability Defense Firm of the Year” by Who’s Who Legal for 14 consecutive years, we also routinely represent clients in arbitration and administrative proceedings. [Read More]