Drugs & Biologics
Kleinfeld, Kaplan & Becker advises on legal and regulatory issues associated with prescription drugs and biologics, including research and development, FDA approval and user fee issues, marketing, and life-cycle management. Our firm also advises on over-the-counter (OTC) drugs, including development and marketing under the CARES Act of 2019. We also support clients in implementing corporate compliance programs to ensure marketing in compliance with law and industry guidelines, including drafting compliance programs and training employees.
Research and Approval
Our firm provides advice on all aspects of drug and biologic research, development, and approval, including:
- Investigational New Drug Applications (INDs)
- New Drug Applications (NDAs)
- Abbreviated New Drug Applications (ANDAs)
- Biologics License Applications (BLAs)
- Drug and device combination products
- Amendments and supplements to applications
- Compliance with post-approval requirements for changes in products, labeling and manufacturing processes
- Establishment registration and product listing
- User fees
- FDA reporting requirements
- Orphan drugs and pediatric drugs
- Controlled Substances
- HIPAA and Privacy Issues
Controlled Substances
Our firm represents clients before the Drug Enforcement Administration and in litigation relating to the oversight of controlled substances, List 1 chemicals, and anabolic steroids. We help resolve issues for our clients pertaining to scheduling, narcotic classification, quota allocation, and exempt status; as well as requirements relating to security, registration, import and export, records and reports, and related issues.
Our firm also advises on lawful production and marketing of Cannabis products, such as hemp products, and the status of such products under federal and state laws relating to controlled substances and hemp.
Current Good Manufacturing Practice (cGMP)
Our firm helps clients comply with FDA’s cGMP regulations by interpreting regulations, case law, agency guidance, and industry practice. We assist in responding to FDA inspectional observations, warning letters, and other enforcement actions relating to pharmaceutical quality.
Safety, Recalls and Reporting
Our firm helps clients assess the risks posed by safety-related manufacturing deviations and contamination, determine whether a recall is needed, and what the scope of any recall should be. We advise on reporting, recall implementation and effectiveness checks, documentation of corrective and preventive actions, and governmental inspections relating to product deviations and recalls.
Labeling and Advertising
Our firm advises on all areas of prescription and OTC drug labeling, including wording, formatting, submission and/or approval of labels, labeling (such as detail pieces), advertising and other promotional materials (including social media and web promotion). We also provide counsel on the interpretation of OTC administrative orders and Drug Facts labeling for OTC drugs. In addition, our firm advises on the use of educational activities and communications with healthcare professionals, and the preparation of policies governing legal compliance for pharmaceutical promotional activities. We also provide guidance on Medicare and Medicaid reimbursement issues, and compliance with drug sampling rules under the Prescription Drug Marketing Act.
Life-cycle Strategic Planning
Our firm advises on strategies for drug and biologic life-cycle management, including exclusivity for brand name and generic products, orphan drug and pediatric exclusivity, and antibiotic exclusivity. We also assist with bioequivalence and substitution issues under federal and state laws; and on patent issues applicable to FDA applications, such as patent registration and extension of patent terms. Our firm also handles legal issues relating to accelerated approval for new therapies for life threatening diseases.
Enforcement
Our firm represents clients in enforcement actions, including responses to FDA inspectional observations, warning letters, recall requests and import detentions, as well as more significant actions such as seizures and injunctions, negotiation of consent decrees, and implementation of FDA’s Application Integrity Policy (AIP).
Contracts and Due Diligence
Our firm supports clients in negotiating and drafting regulatory-related agreements such as guarantees, labeling agreements, supply agreements, quality agreements, etc. We also carry out due diligence analyses of drug and biologic companies and products that are being considered for acquisition or investment.