Strategic Regulatory Advice and Counseling

We advise clients at all stages of the regulatory lifecycle, on matters including:

  • Developing marketing authorization strategies and navigating the FDA processes for conventional drugs, biologics and biosimilars, and medical devices, as well as evaluating classification issues and potential regulatory pathways for combination and borderline products (food v. drug, conventional food v. dietary supplement, human tissue v. biologic, cosmetic v. device), and the business implications of product positioning on the choice of regulatory pathway
  • Crafting life cycle management strategies for small molecule pharmaceuticals and large molecule biological products under the Hatch-Waxman Amendments and the Biologics Price Competition and Innovation Act (BPCIA)
  • Planning and executing product development activities in compliance with Good Clinical Practice requirements
  • Providing post-market compliance counseling with respect to adverse event and medical device reporting, corrections, removals, and recalls, Phase IV study obligations, and changes to product labeling or design
  • Reviewing proposed promotional materials and activities to identify and mitigate regulatory risks
  • Facilitating quality system and cGMP compliance by recommending and tailoring strategies for companies throughout the supply chain, from API manufacturers to contract manufacturers, specification developers, and marketers of finished products (including “virtual” companies)
  • Actively assisting companies to prepare for and respond to questions raised during FDA inspections and to respond to Form 483 Observations and Warning Letters
  • Engaging with regulators to seek clarification, resolve disagreements, and address improper agency actions through both informal interactions, formal administrative procedures and, where necessary or advantageous, though federal court Administrative Procedure Act litigation.

Cross-Agency And Cross-Border Regulatory Advice

Members of FDA-regulated industries also must be aware of and comply with  ancillary federal, state, and international laws that affect their ability to operate. We advise on issues including wholesale distribution and similar state permit or license requirements; regulation of clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) and state laboratory licensure requirements; and state consumer protection laws.

We also work closely with DLA Piper's global Life Sciences sector colleagues in our offices around the world to address regulatory questions whose implications do not end at the US border. DLA Piper is well positioned to provide coordinated advice and multi-jurisdictional surveys, with the benefit of local perspective.

Transactions

FDA insight is critical to a variety of corporate transactions involving FDA-regulated products and companies − from commercial agreements, to M&A transactions, to private company financings, to IPOs. We support clients by applying the broad FDA knowledge that is essential for effective due diligence and for creating risk mitigation and management strategies. Our work includes:

  • Reviewing and analyzing contract manufacturing, supply and distribution agreements relevant to regulatory compliance provisions and documentation of responsibility
  • Conducting regulatory due diligence to identify risks in connection with product development and marketing authorization strategies, promotional and advertising practices, quality system and good manufacturing practices, adverse event reporting, recalls and other product safety concerns, and federal and state registration and licensure
  • Drafting and tailoring regulatory representations and warranties and other risk allocation provisions in M&A agreements, including asset, stock, and membership interest purchase agreements
  • Advising on transition, integration, and other post-closing matters in connection with M&A transactions, including transfer of regulatory authorizations.

Litigation Matters, Investigations, and Risk Assessments

We provide strategic advice for clients in litigation and pre-litigation matters implicating FDA legal and regulatory concerns. We also provide support on matters ranging from product liability cases involving state failure-to-warn claims and manufacturing issues, to investigations and litigation initiated pursuant to the False Claims Act and federal Anti-Kickback Statute.

We also assist in proactive compliance reviews, internal investigations, and litigation and enforcement risk assessments on topics related to compliance with FDA standards, industry standards, and internal policies and procedures, such as:

  • Clinical trial compliance
  • Pharmacovigilance
  • Promotion and advertising
  • Social media and internet communications