Philip Katz > Hogan Lovells US LLP > Washington DC, United States > Lawyer Profile
Hogan Lovells US LLP Offices
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
WASHINGTON DC 20004
DISTRICT OF COLUMBIA
United States
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Philip Katz
Work Department
Pharmaceuticals and Biotechnology
Position
Partner
Career
Philip Katz helps pharmaceutical and biotech companies successfully navigate U.S. Food and Drug Administration (FDA) and related regulatory matters. He counsels them on compliance; helps anticipate and address regulatory issues in their day-to-day business operations and strategic planning; and advocates for them before the FDA, other agencies, and in court. His clients develop, manufacture, and distribute drugs and biologics, spanning from large public companies with extensive product portfolios to startups trying to bring their first product to market.
Phil heads the firm’s Pharma/Biotech practice group, which has 30+ lawyers – many with years of experience at the FDA – who work collegially and in collaboration with our clients to help them achieve their business goals in a highly regulated environment in which good long-term relations with the FDA are essential.
Phil and his team bring together a detailed and nuanced knowledge of the law and FDA precedents, an informed understanding of the client’s business goals, and an experienced appreciation of the public policy implications to craft thoughtful, creative, and practical solutions. He and his team focus particularly on product development, approval, and lifecycle management; responding to agency enforcement activities; and counseling on business transactions. He has deep knowledge of the Hatch-Waxman Act, Orphan Drug Act, and Biosimilars Price Competition and Innovation Act.
Languages
English
Education
J.D., Georgetown University Law Center, magna cum laude, Order of the Coif, 1992; B.A., University of Virginia, with distinction, 1981
Top Tier Firm Rankings
- Transport > Aviation and air travel: litigation and regulation
- Antitrust > Cartel
- M&A/corporate and commercial > Corporate governance
- Media, technology and telecoms > Cyber law (including data privacy and data protection)
- Industry focus > Education
- Government > Government relations
- Dispute resolution > Appellate: courts of appeals / Appellate: supreme courts (states and federal)
- Dispute resolution > Product liability, mass tort and class action - defense: consumer products (including tobacco)
- Transport > Rail and road: litigation and regulation
- Real estate > Real estate investment trusts (REITs)
- Media, technology and telecoms > Telecoms and broadcast: regulatory
- Media, technology and telecoms > Telecoms and broadcast: transactions
- International Trade > Trade remedies and trade policy
Firm Rankings
- Dispute resolution > Appellate: courts of appeals / Appellate: supreme courts (states and federal)
- International Trade > CFIUS
- International Trade > Customs, export controls and economic sanctions
- Labor and employment > Employee benefits, executive compensation and retirement plans: transactional
- Energy > Energy regulation: oil and gas
- Environment > Environment: litigation
- Environment > Environment: regulatory
- Government > Government contracts
- Healthcare > Health insurers
- Healthcare > Life sciences
- Healthcare > Service providers
- Tax > US taxes: non-contentious
- Insurance > Advice to insurers
- Dispute resolution > Appellate: courts of appeals / Appellate: supreme courts (states and federal)
- Finance > Capital markets: debt offerings
- Finance > Capital markets: equity offerings
- Finance > Capital markets: global offerings
- Energy > Energy regulation: electric power
- Finance > Fintech
- Labor and employment > Immigration
- Dispute resolution > International litigation
- Tax > International tax
- M&A/corporate and commercial > M&A: large deals ($1bn+)
- Antitrust > Merger control
- M&A/corporate and commercial > Shareholder activism
- Finance > Structured finance: derivatives and structured products
- Media, technology and telecoms > Technology transactions
- M&A/corporate and commercial > Venture capital and emerging companies
- Antitrust > Civil litigation/class actions: defense
- Energy > Energy litigation: oil and gas
- Finance > Project finance
- Energy > Renewable/alternative power
- Finance > Restructuring (including bankruptcy): corporate
- Finance > Project finance
- Dispute resolution > International arbitration
- Finance > Financial services regulation
- Investment fund formation and management > Private equity funds (including venture capital)