Abram S. Barth

Associate

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  • JD (Health Law Concentration with Honors), cum laude, Boston University School of Law, 2007; symposium editor, American Journal of Law & Medicine; Paul J. Liacos Distinguished Scholar
  • MPH, Boston University School of Public Health, 2008; Health Law, Bioethics, and Human Rights Fellowship
  • BA (Philosophy), with Honors, University of Virginia, 2004

Qualifications

  • New York, 2018
  • District of Columbia, 2016
  • Massachusetts, 2008
  • Food and Drug Law Institute (Present)

Abram S. Barth

Associate

Abram Barth joined Ropes & Gray in 2015 as an associate in the life sciences and health care practice groups. Abram has a wide range of experience counseling on FDA regulation, with a particular focus on medical devices, combination products, and clinical research.

Prior to joining Ropes & Gray, Abram worked in the Food and Drug Administration’s Office of Chief Counsel, most recently as Associate Chief Counsel, serving as Team Leader of the device practice group. 

He has significant experience advising clients on the life cycle of medical devices, including clinical trials (IDEs, IRBs, informed consent), premarket submissions (510(k)s, PMAs), advertising and promotion, quality system regulation (QSR), medical device reporting (MDR), and postmarket surveillance and studies, as well as the premarket and postmarket regulation of combination products. In addition, Abram was a principal attorney advising the FDA and HHS on clinical research compliance and policy, and served as counsel to FDA’s IRB for six years.

Abram has advised FDA on emergency preparedness matters, including serving as the lead device attorney for FDA’s response to the 2014 Ebola outbreak and counsel during the 2009 H1N1 outbreak, regarding exportation, importation, and Emergency Use Authorization of investigational medical devices.

He has been recognized with numerous awards at FDA, including the Commissioner’s Award of Excellence, Commissioner’s Special Citation, Commissioner’s Special Recognition, and Group Recognition.

Abram also has taught FDA Policymaking at George Washington University School of Public Health.

Experience

FDA Regulatory and Compliance

  • Advised device companies on regulatory submission pathways, including 510(k) notification, de novo petition, and premarket approval application (PMA)
  • Reviewed and conducted risk assessment of promotional materials and policies for pharmaceutical and medical device companies
  • Counseled major device company on regulatory framework for device labeling, promotion, and advertising
  • Advised on regulation of mobile medical applications
  • Counseled on device jurisdictional and classification assessments
  • Advised on issues related to GMP compliance for drugs, devices, and combination products
  • Advised on issues related to Medical Device Reporting and adverse event reporting for combination products
  • Advised device companies on removals, corrections, recalls, and market withdrawals
  • Analyzed device companies’ Instructions For Use brochures for compliance with 510(k) clearance
  • Reviewed labeling updates for a medical device company
  • Advised pharmaceutical and device companies on informed consent obligations, IRB requirements, and sponsor and investigator responsibilities
  • Counseled pharmaceutical companies on expanded access programs
  • Performed regulatory diligence in numerous corporate transactions involving pharmaceutical and medical device companies
  • Advised a pharmaceutical company on regulatory issues associated with switching a product from prescription to over-the-counter status
  • Assisted a device company in responding to FDA Warning Letter alleging violations of Good Clinical Practice regulations
  • Counseled FDA-regulated companies on reporting adverse events during clinical trials
  • Advised a drug company regarding compliance with OTC Drug Review
  • Advised on orphan, pediatric, and 180-day exclusivity issues
  • Counseled food and dietary supplement companies regarding recalls, market withdrawals, and complaint handling procedures

Clinical Research

  • Counseled clinical trial sponsors, investigators, and IRBs in drafting consent forms, developing and negotiating clinical site agreements, and delineating roles and responsibilities in multisite and multiparty research
  • Assisted pharmaceutical companies in the development of policies and procedures for the conduct of clinical research
  • Advised research institutions regarding research compliance under HIPAA, FDA regulations, the Common Rule, state requirements, and international laws
  • Advised research institutions and drug and device companies on the proposed revisions to the Common Rule and drafted comments on their behalf
  • Counseled on the sharing, use, acquisition, transportation, and dissemination of identifiable and de-identified data and biospecimens for secondary research purposes
  • Advised on data security matters

Publications

Presentations

  • Food and Drug Law Institute, “Drug Post-Approval Issues,” Washington, D.C. (November 2-3, 2017)
  • Food and Drug Law Institute, “Quality System Regulation,” Washington, D.C. (April 26-27, 2017)
  • New York Pharma Forum, “The 21st Century Cures Act: Implications for Pharma and Biotech Companies,” New York, NY (March 21, 2017)
  • Food and Drug Law Institute, “Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs) and Informed Consent,” Washington, D.C. (November 2-3, 2016)
  • Food and Drug Law Institute, “FDA and CDRH Organization Structures,” Washington, D.C. (November 2-3, 2016)
  • Food and Drug Law Institute, Hot Topics in Medical Device Law, “Postmarket Studies: Confirming Device Performance,” Washington D.C. (March 31, 2016)
  • American Conference Institute, 27th Annual FDA Boot Camp, “Medical Product cGMPs,” New York, NY (March 10, 2016)