Abraham Gitterman focuses on FDA and healthcare regulatory, compliance, and fraud and abuse matters involving pharmaceutical and medical device manufacturers. He regularly counsels clients on FDA-regulated advertising and promotion, including use of social media; compliant medical affairs activities, including continuing medical education (CME); appropriate interactions with healthcare professionals; and mobile health applications. Abraham also assists with extensive reviews of corporate compliance programs, both generally and pursuant to Corporate Integrity Agreements (CIAs) with OIG, for various life science companies and healthcare entities to ensure compliance with the Anti-Kickback Statute; the False Claims Act; and the Federal Food, Drug, and Cosmetic Act. Abraham also has extensive experience counseling clients on the Physician Payments Sunshine Act and related state transparency and "gift ban" laws. He also advises clients on compliance with the Drug Supply Chain Security Act (DSCSA) and the Compounding Quality Act.
Prior to joining the firm, Abraham was a research associate at a national ACCME-accredited CME provider, where he assisted drafting medical education grant applications and evaluated various conflict of interest policies regarding physician relationships with manufacturers. Abraham received a Health Law Certificate from the Law & Health Care Program at the University of Maryland Francis King Carey School of Law. During law school, Abraham clerked with the U.S. Department of Justice, Consumer Protection Branch; The Office of Counsel to the Inspector General for the Department of Health and Human Services (OCIG); and the FDA Office of Policy. Abraham also founded the Health Law Regulatory & Compliance Competition.
Experience
- Counsel various pharmaceutical manufacturers in assessing the FDA and healthcare compliance risks associated with medical and commercial activities and planning.
- Serve as outside counsel to various pharmaceutical manufacturers for the review of promotional and medical materials, including serving on promotional and medical review committees.
- Advise various drug and device manufacturers on best practices for compliant social media activities, including use of patient and HCP influencers and ambassadors, including potential FDA and healthcare compliance risks.
- Assist various drug and device manufacturers on the FDA, FTC, and healthcare regulatory framework for digital health products, including mobile medical applications, general wellness products, clinical decision support tools, and other health IT products.
- Advise various drug and device manufacturers on best practices for compliant activities involving EHRs, clinical decision support (CDS), artificial intelligence (AI), and related digital health initiatives related to drugs, biologics, and medical devices, to address potential FDA, fraud and abuse, and healthcare compliance risks.
- Advise various drug and device manufacturers on best practices for compliant medical affairs interactions, promotional activities, payor communications, patient interactions, and reimbursement support, as well as interactions with healthcare professionals (HCPs) and healthcare institutions.
- Various pharmaceutical manufacturers in conducting extensive audits and reviews of their medical affairs functions, including medical science liaison activities and interactions.
- Counsel various drug and device manufacturers by providing strategic legal counseling on various federal and state track and trace, supply chain, distribution, and licensure issues, including compliance with the Drug Supply Chain Security Act (DSCSA) and state wholesale drug distribution, dispensing, and 3PL laws.
Perspectives
Recognition
1st Place, Fifteenth Annual Epstein Becker & Green Annual Health Law Writing Competition (2013)
Runner-Up, 11th Annual American Bar Association Health Law Student Writing Competition (2013)
Credentials
Education
- J.D., University of Maryland Francis King Carey School of Law, 2013, magna cum laude, Order of the Coif
- B.A., History, The Pennsylvania State University, 2008
- B.A., Political Science, The Pennsylvania State University, 2008
- B.A., Criminal Justice, The Pennsylvania State University, 2008
Admissions
- New Jersey
- Pennsylvania