Drugs & Biologics

Our Work

Our FDA and health care regulatory attorneys work hand-in-hand with clients to address the entire range of regulatory and marketing issues that can occur throughout a pharmaceutical product’s life cycle, from the early stages of development through post-market.

How We Help

Product Development

Our product development work includes:

• Helping innovator drug companies develop strategies for marketing approval of drugs and biologics
• Drafting and filing Investigational New Drug Applications, New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), 505(b)(2) Applications, Animal Drug Applications, Biologic Licensing Applications, and Biosimilar 351(k) applications
• Drafting research and license agreements
• Assisting with clinical trial agreements and reporting issues
• Advising on FDA pre-market approval inspections
• Performing domestic and foreign pre-FDA inspection audits
• Representing companies before the FDA to expedite product approval
• Preparing for and participating in FDA Pre-IND, Pre-NDA, and advisory committee meetings
• Counseling clients on ways to extend — or limit — patent and exclusivity protection under the Hatch-Waxman Act
• Working with drug companies to overcome stalled development plans
• Filing Citizen Petitions (or responses to Citizen Petitions) to prevent or allow the approval of generic drugs
• Advising universities and hospitals on clinical research compliance
• Drafting Quality Agreements and Pharmacovigilance Agreements among manufacturers, suppliers, and NDA/ANDA applicants/sponsors
• Representing clients in DEA administrative hearings

Post-Approval

Our clients turn to us with a wide range of regulatory concerns after their pharmaceutical products have gone to market.

Recent regulatory-related activities include:

• Providing advice on adverse event reporting, Field Alert Reports, and the handling of recalled drugs, including the development of crisis management programs and plans
• Helping clients understand regulatory issues involving the marketing and manufacturing of drug and biologic products, including reviewing and offering advice on proposed advertising, labeling, and promotional materials
• Filing numerous supplements to approved NDAs and ANDAs, as well as assisting in the preparation of Annual Reports and Periodic Adverse Drug Experience Reports
• Serving as regulatory counsel in support of drug developers’ initial public offerings
• Counseling clients before, during, and after FDA inspections and preparing responses to FDA Forms 483 and Warning Letters
• Preparing Requests for Designation to obtain FDA rulings on whether products should be regulated as drugs, biologics, or devices
• Counseling clients on nationwide recalls of several drug products and devising strategies to limit adverse publicity
• Conducting audits of manufacturers’ adverse event reporting compliance
• Developing SOPs for post-marketing compliance issues affecting the promotion of pharmaceuticals
• Advising manufacturers, repackagers, distributors, 3PLs, and dispensers on compliance with the Drug Supply Chain Security Act (DSCSA) and state/federal licensure requirements associated with drug distribution
• Conducting investigations relating to potential research misconduct and possible diversion of controlled substances on clients’ behalf
• Responding to subpoenas from the US Department of Justice on investigations

Due Diligence Reviews

ArentFox Schiff attorneys are regularly called upon to provide due diligence reviews prior to the acquisition of a product, company, or pharmaceutical plant. Most recently, this included a months-long review of a European company’s intended acquisition of multiple plants in the United States.