Martha M. Rumore
Martha M. Rumore, PharmD, Esq, MS, LLM, FAPhA is a pharmacist-attorney in Frier Levitt’s Life Sciences Department. Her practice focuses on healthcare law; Food, Drug Cosmetic law; pharmacy law and regulatory issues; PBM issues; as well as pharmaceutical and medical device intellectual property including trademark, copyright, trade secret and all aspects of patent law (due diligence, prosecution, opinion work, litigation, and transactional matters). Dr. Rumore has over 15 years of law firm experience in the area of Food, Drug & Cosmetic Law and pharmaceutical intellectual property, counseling on early market opportunities for pharmaceutical clients particularly in the area of ANDA and 510K applications and all facets of Paragraph IV litigation.
Dr. Rumore has also worked in Drug Regulatory Affairs in the pharmaceutical industry and hospital pharmacy, both at the Director level. She taught Pharmacy Law and Drug Regulatory Affairs at Arnold & Marie Schwartz College of Pharmacy and Touro College of Pharmacy for close to 20 years and currently teaches Food, Drug & Cosmetic Law at Maurice A. Deane School of Law at Hofstra University.
She is a frequent lecturer and has over 200 publications and presentations. Additionally, Dr. Rumore is a Fellow and former Trustee of the American Pharmacists Association, a former Board member of the American Society for Pharmacy Law and the Accreditation Council for Pharmacy Education and is a three-time recipient of the Larry Simonsmeier Legal Writing Award.
- Benjamin N. Cardozo School of Law, Master of Laws (LLM), Intellectual Property Law
- City University of New York, School of Law, J.D.
- Arnold & Marie Schwartz College of Pharmacy, M.S. Drug Information & Biomedical Communication
- St. John’s University, College of Pharmacy, Pharm.D.
- St. John’s University, College of Pharmacy, B.S. Pharmacy
- State of New Jersey
- State of New York
- Washington, D.C.
- U.S. Patent and Trademark Office
- U.S. District Court, Southern District of New York
- U.S. Court of Appeals, Federal Circuit
- U.S. District Court, District of New Jersey
Book Chapter. Legal and Regulatory Issues in Self-Care Pharmacy Practice. In Krinskt DL (ed).Handbook of Nonprescription Drugs. Chapter 4. 20th ed., American Pharmacists Association, Wash. D.C., 2020
Book Chapter. Patents in Pharmaceutical Development. In Smith CG, O’Donnell JT. The Process of Drug Discovery and Development. 3nd ed. Informa Press, 2020 (In press).
Book Chapter. Legal and Regulatory Issues in Self-Care. In Krinsky DL (ed). Handbook of Nonprescription Drugs. Chapter 4. 19th ed., American Pharmacists Association, Wash. D.C., 2017. pp.57-74.
Book Chapter. Legal Aspects of Drug Information Practice. In Malone PM, Stanovich J., Kier K, Malone MJ (eds.) Drug Information: A Guide for Pharmacists. Norwalk, Connecticut, McGraw Hill, New York, 1996, pp. 169-186; 2nd ed. 2001 pp. 276-201; 3rd ed. 2005, pp. 411-457; 4th ed. 2011 pp. 505-553, 5th ed. 2014 pp. 503-568, 6th ed. 2017 pp.489-543, 7th ed. 2020 (In press).
Rumore MM, Vogenberg R. PBM P&T Practices: The HEAT Initiative Gaining Momentum. P&T Journal. May 2017.
Vogenberg FR, Marcoux R, Rumore MM. Systemic Market and Organizational Changes: Impact on P&T Committees. P&T Journal. 2017:42(1):28-32.
Wong A YT, Rumore MM, Chan AK. Biosimilars in the United States: Emerging Issues in Litigation. BioDrugs. 2017 (April); DOI 10.1007/s40259-017-0216-7.
Chin A, Sniggs J, Rumore M. Analysis of Postmarket Safety Label Changes: Comparison of Expedited versus Standard New Drug Application Approvals. APhA 2017 Abstracts Contributed Papers. J Amer Pharm Assoc. 2017 (May):57(3); DOI
Rumore M. Evolving Biosimilar Litigation: Implications for Interpretation of the Biologics Price Competition and Innovation Act (BPCIA). APhA 2017 Abstracts Contributed Papers. J Amer Pharm Assoc. 2017 (May):57(3); DOI
Chin A, Sniggs J, Rumore MM. Analysis of Postmarketing Safety Labeling Changes: Comparison of Expedited Versus Standard NDA Approvals. In Process.
Rumore MM. Pharmacy-Based Naloxone Access. Res Ipsa Loquiter. June 2016;43(3):1, 3.
Rumore MM, Vogenberg FR. Biosimilars: Not Quite Ready for Prime Time. P&T Journal. 2016;41(6):366,368-375.
Vogenberg FR, Rumore MM. Oncology Biosimilars: Opportunity or Not? J Assoc Value Based Cancer Care. 2016(April);7(3):1-8.
Rumore MM, Cobb E, Sullivan M, Wittman D. Biosimilars: Challenges and Opportunities for Nurse Practitioners. J Nurse Practitioners. 2016;12(3):181-191.
Rumore MM. Medication Repurposing in Pediatric Patients: Teaching Old Drugs New Tricks. J Pediatr Pharmacol Ther. 2016;21(1):36-53.
Rumore MM, Choy M, Cohen KR. Analysis of MedWatch Alerts 2009-2014. J Amer Pharm Assoc 55(2): e233-234. doi:10.1331. March/April 2015.
Rumore MM. Post Caronia: Is a New Paradigm Needed for Off-Label Medication Usage? J Medical Marketing. 2013;13(4):212-220.
Rumore MM, Ligniti E, Schwartz R. Increasing HangTime for Premixed Solutions to 96 Hours: Phase I (Abstract) J Amer Pharm Assoc 53(2):85 (March/April 2013).
Patel Y, Rumore MM. Makena or Compounded 17P? (Letter to the Editor). P&T Journal. 2012:37(9):488-489.
Patel Y, Rumore MM. Hydroxyprogesterone Caproate Injection One Year Later: To Compound or Not to Compound- That is the Question? P&T Journal. 2012:37(7):405-411.
Rumore M. The Hatch-Waxman Act-25 Years Later: Keeping the Pharmaceutical Scale Balanced. August 2009. Pharmacy Times. Generic Drug Supplement. August 2009
Rumore M, Colloca B. New Law Brings Changes to Medicare Part D, Pharmacy Times, January 2009, pp. 43-45.
Rumore M. Recent Trends in Lanham Act Litigation Involving Generic Substitution (Abstract). J. Amer. Pharm. Assoc., 48(2):288, 2008.
Rumore M, Safe Harbor or Pirate Cove? Merck v. Integra and Its Seeming Impact on International Research Activities. SciTech Lawyer 3(3):12-15, Winter 2007.
Restino L, Rumore MM. Safe Harbor or Uncharted Seas? Integra v. Merck Currents. N.J. Lawyer 14(20):1,6, 2005.
Vepachedu S, Rumore M. Patent Protection and the Pharmaceutical Industry in the Indian Union. Intellectual Property Today 11:44-46, Oct. 2004.
Vepachedu S, Rumore M. The Pharmaceutical Industry and the New Patent Regime in the Indian Union. Andhra J. Indust. News, Issue 10, Jan. 10, 2005
Rumore M. Determinants of Patenting in the U.S. Pharmaceutical Industry Based on Recent CAFC Case Law. J. Amer. Pharm. Assoc. 44:298, Mar/April 2004.
Rumore M. Ranbaxy Pharmaceuticals v. Apotex. Redefining Claim Drafting and Patent Prosecution Under Festo. ABA Intellectual Property Newsletter. 22:12-15, Summer 2004.
Rumore M. Direct to Consumer Advertising of Prescription Drugs- Emerging Legal and Regulatory Issues. Hospital Pharmacy, 39:158-1068, Nov. 2004.
Rumore M. Recent Legislative Reform and Judicial Interpretations of Employee Health Benefit Malpractice Claim Preemption Under ERISA. J. Pharm. & Law. Winner of the 1999 Larry Simonsmeir Legal Writing Competition.
Rumore M. The Role of Pharmacists in the Pharmaceutical Trademark Evaluation Process. (Abstract). Amer. Pharm. Assoc. J. 6:83-95, 1997.
Rumore M. Analysis of Class I Recalls 1982-1996. Drug Info. J. 32:65-71, 1998.
Rumore M. Pharmacy and Tobacco. Annals Pharmacother. 1998;31:1253-56.
Rumore M. The Drug Product Recall System and the Pharmacist: Are Consumers Protected? New York State J Health System Pharm. 15:5-10, 1996.
Pharmacy Legislative, Regulatory & Case Law Update. Getaway Pharmacy Continuing Education Seminar. Staten Island, NY, July 29, 2018, Atlantic City. Sept. 22, 2019.
Biosimilars: Opportunities and Challenges for Pharmacists. Indian Congress of Pharmacy Practice- 2018 & 3rd Convention of the Indian Association of Colleges of Pharmacy. Hyderabad, India. May 28, 2018.
Biosimilars- The Patent Dance and State Substitution Laws. Academy of Managed Care Pharmacy. Webinar. Sept 20, 2017.
Sahetya SS, Rumore MM. Priority Review Voucher: Can the Objective be Realized? Poster. Drug Information Association Annual Meeting. Chicago, IL. June 18-22, 2017.
Makarious K, Fdaee S, Rumore MM. Analysis of FDA Guidance of Off-Label Medical Product Advertising. Poster. Drug Information Association Annual Meeting. Chicago, IL. June 18-22, 2017.
Pharmacy Legislative, Regulatory and Case Law Update. 32nd Annual Northeast Regional Pharmacy Conference Seminar by the Sea. Newport, R.I. March 17, 2017.
Rumore MM. Evolving Biosimilar Litigation: Implications for Interpretation of the Biologics Price Competition and Innovation Act (BPCIA). American Pharmacists Association Annual Meeting. San Francisco, CA. March 24-27, 2017.
Lakhram R, Gragjevi E, Rumore MM. Analysis of Off-Patent Pharmaceutical Price Increases: 2013-2016. Poster. American Pharmacists Association Annual Meeting. San Francisco, CA. March 24-27, 2017.
Chin A, Sniggs J, Rumore MM. Analysis of Post-market Labeling Changes: Comparison of Expedited Versus Standard NDA Approvals. Podium presentation. American Pharmacists Association Annual Meeting. San Francisco, CA. March 24-27, 2017.
Invited Speaker- New York State Council of HealthSystem Pharmacists. New York State Pharmacy Law Update-2016. New York, NY, November 12, 2016.
Invited Speaker. Legislative and Regulatory Update- Focus on Provider Status. Dean’s Hour. Touro College of Pharmacy. November 7, 2016.
Lakhram R, Gragjevi E, Rumore MM. Analysis of Off-Patent Pharmaceutical Price Increases: 2013-2016. Drug Information Association 52nd Annual Meeting. Philadelphia, PA. June 27, 2016.
Chin A, Sniggs J, Rumore MM. Analysis of Post-market Labeling Changes: Comparison of Expedited Versus Standard NDA Approvals. Drug Information Association 52nd Annual Meeting. Philadelphia, PA. June 27, 2016.
New York State Council of HealthSystem Pharmacists. New York State Pharmacy Law Update-2016. New York, NY, May 7, 2016.
Cost Avoidance Assessment of Pharmacist’s Interventions at a Metropolitan Pediatric Hospital, NSLIJ Afternoon of Innovation, New Hyde Park, NY, March 7, 2014. Recognized Innovation Award.
Legal, Regulatory and Compliance Update for Controlled Substances: Implications for Pharmacy Practice. Greater New York Hospitals Association. Webinar. April 22, 2014.
Piperacillin/Tazobactam (PT) Dosage Error Reduction in Pediatric Patients. Poster. New York State Council of Hospital Pharmacists Annual Meeting, Saratoga, NY, May 1, 2014.
Off- Label Medication Usage: Balancing the Standard of Care, Legal, and Safety Considerations. Greater New York Hospital Association. Teleconference and Webinar. October 24, 2013.