Practice Areas

Drugs & Biologics

KKB handles legal and regulatory issues associated with prescription drugs and biologics, as well as OTC drugs – including development, FDA approval, and marketing. Our focus is on strategic planning to minimize regulatory problems and maximize the availability of safe and effective products. We routinely negotiate with FDA on legal and policy issues, and engage in litigation relating to FDA regulation and enforcement.

KKB assists clients in developing and implementing healthcare compliance programs in accordance with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Healthcare Professionals, the AdvaMed Code of Ethics on Interactions with Health Care Professionals, and related state laws, such as California’s S.B. 1765 (2004). KKB drafts key documents for clients, including detailed policies and procedures, needed to support a client’s compliance program and will conduct training of affected employees. KKB monitors enforcement trends and helps clients keep compliance programs up to date.

Labeling and Advertising

KKB has expertise in all aspects of prescription and OTC drug labeling. We advise on the proper wording, formatting, submission and/or approval of labels, labeling (such as detail pieces), advertising and other promotional materials (including social media and internet promotion). We advise on the interpretation of OTC monographs and Drug Facts labeling for OTC drugs. We also advise 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 advise on state law in this area, such as laws governing reporting of gifts to healthcare professionals.

KKB advises on Medicare and Medicaid reimbursement issues and corporate compliance programs. We also advise on Prescription Drug Marketing Act compliance with drug sampling rules.

Research and Approval

KKB’s advice covers all aspects of drug research and approval, including:

  • Licensing and related issues for:
    • Investigational New Drug Applications (INDs)
    • New Drug Applications (NDAs)
    • Abbreviated New Drug Applications (ANDAs)
    • Biologics License Applications (BLAs)
    • Amendments and supplements to applications
  • Compliance with post-approval requirements for changes in products, labeling and manufacturing processes
  • Interpretation and application of FDA current good manufacturing practice (cGMP) requirements
  • Establishment registration and product listing
  • Establishment, application, and product user fees
  • FDA reporting requirements
  • Orphan drugs and pediatric drugs
  • Controlled Substances
  • HIPAA and Privacy Issues

Life-cycle Strategic Planning

KKB advises on strategic planning for the development of new drugs, including exclusivity for innovator drugs and generic drugs; bioequivalence and substitution issues under federal and state laws; and FDA-related patent issues, including patent listing, patent certification, and patent term extension.

Enforcement

KKB handles a wide range of drug-related enforcement activities by FDA, FTC, DEA and other federal and state regulatory agencies. These include:

  • FDA enforcement proceedings, including the conduct of inspections, responses to inspectional observations, Warning Letters, section 305 hearings, negotiation of consent decrees, litigation, and implementation of FDA’s Application Integrity Policy (AIP)
  • FDA-related import and export issues
  • Assistance with recalls
  • FTC investigations of advertising claims
  • Self regulatory cases involving drug claims (before the National Advertising Division (NAD))

Contracts, business planning and due diligence

KKB assists clients in drafting agreements relating to regulatory issues, such as guarantees, labeling agreements (for exemption from labeling requirements for drugs to be further manufactured), agreements for clinical studies, etc. We assist business planners in evaluating the investment needed to support new products, ingredients and claims. We also conduct due diligence reviews of drug companies and products that are being considered for acquisition.