+1 202 637 5632
+1 202 637 5910
Partner, Washington, D.C.
Philip Katz heads Hogan Lovell’s Pharmaceutical and Biotechnology regulatory practice. He advises companies, universities, trade associations, and individuals in matters arising under regulation by the U.S. Food and Drug Administration (FDA) and related federal and state agencies. His clients are primarily manufacturers and distributors of drugs (prescription and over-the- counter) and biologics, ranging from large public companies with mature product portfolios to startups that have yet to bring a product to market. Phil counsels them on matters of regulatory compliance, helps them anticipate and address regulatory issues in their day-to-day business operations and strategic planning, and advocates on their behalf before the FDA, other agencies, and in court.
His practice includes a particular focus on issues involving product development, approval, and lifecycle management (including application of the Hatch-Waxman Act, Orphan Drug Act, and the Biosimilars Price Competition and Innovation Act), responding to agency enforcement activities, and counseling business transactions. Before practicing law, Phil was a legislative staff member in the U.S. House of Representatives and later a lobbyist.
Phil has long been active in the Food and Drug Law Institute and a member of its Board of Directors, where he currently is the immediate past Chair of the Board, and a member of the Executive Committee.
A frequent speaker on a range of topics, Phil has been a guest university lecturer on matters of FDA law.
- Working with an innovator manufacturer’s medical, regulatory, and legal staff to draft and submit a petition raising bioequivalence issues that must be addressed before any generic products can be approved.
- Helping a client maintain compliance with Prescription Drug Marketing Act requirements and restrictions governing distribution of prescription drug samples.
- Advocating on a manufacturer’s behalf before state regulators to ensure that patient safety issues are considered as state formularies consider allowing generic substitution for the company’s product.
- Leading a 12-person team providing strategic advice on product life cycle issues and conducting U.S. and EU regulatory due diligence in a possible $7.5 billion acquisition of a pharmaceutical manufacturer.
- Defending a clinical investigator in the first disqualification hearing held in years, the result of the FDA's increasingly aggressive enforcement activities aimed at clinical investigators and their institutions.
- Advising an academic institution on how to internally address evidence of serious noncompliance by a clinical investigator, and helping the institution interact with FDA and the Office for Human Research Protection to bring the matter to a successful conclusion.
- Working with a company’s clinical trials and medical/science teams to seek FDA agreement to revise a Special Protocol Assessment for an ongoing clinical trial.
- Working with an industry organization to develop policy positions regarding proposals for expanded clinical trial registries and data reporting.
- Successfully suing FDA in federal court to block the agency from giving a competitor's product an advantage in the New Drug Application approval process, instead requiring FDA to treat all competitors equally.
- Representing a drug manufacturer in federal court and in negotiations with the FDA to resolve the agency's seizure of a large quantity of product at a distributor's warehouse. The settlement permitted the company to continue distributing the product.
- Helping a company obtain release of an imported active ingredient that had been detained at the port of entry, and then comply with requirements applicable to the manufacture for export of a finished product not approved for U.S. distribution.
Hogan Lovells Publications
30 October 2015
"Bring Your Own Smartphone: FDA Requests Comments on the Use of Innovative Technologies to Conduct Clinical Trials." Pharmaceutical and Biotechnology and Medical Device Alert, Hogan Lovells
23 February 2015
"FDA Publishes Draft Guidances and Memorandum of Understanding on Drug Compounding and Repackaging." Pharmaceutical and Biotechnology Alert, Hogan Lovells
13 February 2015
"FDA Announces Major Proposed Rule Amending Hatch-Waxman Regulations." Pharmaceutical and Biotechnology Alert, Hogan Lovells
26 June 2013
"Decision that design-defect claims against generic manufacturers are pre-empted may have broad impact." Supreme Court Alert, Hogan Lovells
07 January 2013
"Focus on Life Sciences Industry Trends for 2013." Life Sciences Alert, Hogan Lovells
04 October 2012
"FDA denies 5-year exclusivity to “stable esters” and confirms structure-based approach to exclusivity." Pharmaceutical and Biotechnology Alert, Hogan Lovells
27 April 2010
"Clinical Trials and Alien Tort Statute Jurisdiction." Pharmaceutical and Biotechnology Update, Hogan & Hartson LLP
26 April 2010
"New Health Care Reform Law Includes Tax Credit/Grant Program for Companies Developing Therapeutic and Diagnostic Products." Tax Update: Pharmaceutical, Biotechnology, and Medical Device Companies, Hogan & Hartson LLP
16 March 2009
"Waxman Bill Creates Risks, Opportunities." Pharmaceutical and Biotechnology Update, Hogan & Hartson LLP
12 July 2007
"Eighth Circuit Clarifies Ownership of Research Specimens in Washington University v. Catalona." Pharmaceutical and Biotechnology Update, Hogan & Hartson LLP
12 July 2007
"Eighth Circuit Clarifies Ownership of Research Specimens in Washington University v. Catalona." Health Update, Hogan & Hartson LLP
01 July 2005
"Expanded Research Exemption in Merck v. Integra." Pharmaceutical and Biotechnology Update, Hogan & Hartson LLP
25 February 2005
"FDA Drug Safety Reforms Take Shape." Pharmaceuticals & Biotechnology Update, Hogan & Hartson LLP
29 December 2004
"FDA Continues to Re-examine Part 11: Compliance Focus Now on Clinical Trials." FDA Update, Hogan & Hartson LLP
03 October 2012
"Regulatory: Individual liability for corporate FDCA violations—What you don’t know can hurt you." InsideCounsel, Summit Business Media
"Determining Patient Access to Investigational Drugs in the US." RAJ Pharma, Informa UK Ltd