Increased scrutiny by the U.S. Food & Drug Administration has made skilled legal counsel essential for businesses in the biological, food, medical device, pharmaceutical and tobacco industries.

At Fox Rothschild, we help clients effectively address FDA concerns and anticipate hurdles that may arise as they strive to grow and expand their businesses. We provide strategic counseling on product formulation, premarket approval processes, labeling, required warning statements, good manufacturing practices, claim substantiation, recall issues and other matters across FDA product centers. We also help clients successfully navigate the complicated intersection of regulations promulgated by the Federal Trade Commission and the FDA, particularly in connection with advertising and product dissemination. Additionally, we advise clients on the scope of FDA health warning requirements and the intersection of such warnings with state requirements, such as those required by California’s Proposition 65.

Our team of attorneys has a deep understanding of the statutes and regulations under which the FDA operates, gained from experience serving both as lead outside counsel for regulatory and litigation matters for dietary supplement, medical device, pharmaceutical and tobacco companies and industry trade associations, and as in-house general counsel, chief compliance officer and other senior executive positions. Fox attorneys are also active in the renowned Food and Drug Law Institute, serving on its Academics Programs Committee and Policy Forum Editorial Advisory Board.

Regulatory Compliance

For both private and public companies, we offer guidance on regulatory compliance throughout the product life cycle, from development and approval/clearance to advertising, marketing and distribution. We not only advise manufacturers regarding their regulatory obligations, but also work with distributors and retailers to offer those companies guidance on their unique place in product distribution.

Our services include:

  • Providing strategic advice to senior management on new FDA rules
  • Proactively petitioning the FDA, on behalf of clients, to alter regulations
  • Advising on FDA compliance related to Quality System Regulations (QSR) and Current Good Manufacturing Practice (cGMP)
  • Counseling on the new Food Safety Modernization Act (FSMA), food labeling and consumer fraud
  • Counseling on the Tobacco Control Act and the Final Deeming Rule
  • Assisting in the development, implementation and operation of targeted compliance tracking systems and business programs, including FDA QSR/cGMP employee and internal auditor training
  • Assisting companies with tobacco manufacturing establishment registration and ingredient reporting
  • Advising and assisting companies with implementation of tobacco health warnings on packaging and advertising
  • Assisting companies in developing appropriate product testing protocols and working with independent laboratories to test tobacco products for harmful and potentially harmful chemicals (HPHCs)
  • Providing clinical trial development and oversight, including drafting and negotiating multisite collaborative clinical trial agreements
  • Preparing and submitting applications, including 510(k)/PMA/DMF, Abbreviated New Drug Application (ANDA), New Drug Application (NDA),Drug Master File (DMF) submission services, Tobacco Substantial Equivalence (SE) 905(j) reports, New Tobacco Product Application (PMTA), Modified Risk Tobacco Product Application (MRTP) and Tobacco Product Master File (TPMF)
  • Reviewing product promotional materials to ensure compliance – from labeling to advertising and beyond
  • Advising on company strategies to help minimize risk related to product liability, antitrust and corporate compliance
  • Conducting training on the False Claims Act, anti-kickback statutes, Health Insurance Portability and Accountability Act (HIPAA), Stark laws and Medicare and Medicaid conditions of participation

Crisis Intervention and Litigation Services

We offer assistance with:

  • FDA audits and enforcement
  • Internal corporate audits and investigations to manage and mitigate risk
  • Government inspections
  • Preparing replies to FDA 483 and warning letters
  • Implementing corrective action or product recall
  • Undergoing a clinical trial investigation
  • Medical Device Reporting (MDR) filing
  • Recall litigation and counseling
  • Consumer fraud and labeling litigation
  • Risk assessment and corporate due diligence
  • Preparing comments to any proposed rules of guidance from FDA centers