Biography

DANIEL G. GOTTLIEB is an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green. He focuses his practice on health care matters impacting the medical technology and life sciences industry, including FDA and FTC advertising and promotional counseling, clinical research contracting and compliance, and fraud and abuse counseling.

Mr. Gottlieb's experience includes:

  • Counseling clients with respect to FDA and FTC advertising and promotional compliance, including supporting client's promotional review activities. In 2014, Mr. Gottlieb was seconded to a large medical device manufacturer to serve as the legal representative on the company's promotional review committee.
  • Supporting pharmaceutical and medical device companies' clinical trial contracting efforts. By capitalizing on Epstein Becker Green's relationships with local counsel throughout the world, Mr. Gottlieb is able to provide consistent legal oversight to clients' clinical contracting activities. Because of his oversight, clients can obtain more consistency in their clinical study agreements by making country-specific changes to their templates instead of making company-specific changes to a country template.
  • Counseling pharmaceutical and medical device companies with respect to clinical research compliance. Mr. Gottlieb plays an active role in overseeing the adaptation of informed consent documents necessary to meet local requirements. This allows Mr. Gottlieb to help his clients ensure that these adaptations meet the local legal and regulatory requirements, remain in compliance with U.S. FDA requirements, and continue to protect the clients' interests.
  • Advising medical technology companies in the development of FDA pre-market clearance and approval and reimbursement strategies. Epstein Becker Green's life sciences and medical technology attorneys not only include individuals well versed in FDA regulatory issues but also individuals with extensive experience in developing and implementing coding, coverage, and payment strategies for novel medical technologies. As a result, Mr. Gottlieb and his colleagues are able to build cross-functional teams to help innovative medical technology companies align their regulatory and reimbursement pathways early in the product development process.
  • Counseling pharmaceutical and medical device companies with respect to compliance with state and federal wholesale distribution licensure requirements.

Mr. Gottlieb also serves as legal counsel to the Combination Products Coalition (CPC), a group of leading pharmaceutical, medical device, and biologics manufacturers focused on regulatory issues impacting combination products. In this role, Mr. Gottlieb develops the CPC's priorities and strategic plan, based on feedback from the members. Mr. Gottlieb also is responsible for implementing aspects of the CPC's strategic plan, which has historically included meeting with individuals at FDA and members of Congress and their staff, and drafting comment letters on FDA guidance documents and proposed rules that are likely to significantly impact combination products.

Education

  • Seton Hall University School of Law (J.D.)
    • Health Law Concentration, magna cum laude, Order of the Coif
  • Georgia Institute of Technology (B.S.)

Bar Admissions

  • District of Columbia
  • New Jersey

Memberships

  • American Health Lawyers Association